Trial Outcomes & Findings for Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics (NCT NCT04479618)

Results Overview

If wound infection, healing impairing maceration, wound deterioration, etc. are suspected by the patient, the two blinded off-site observers viewing wound photos, or a member of the research study team, all dressings will be removed and the ulcer will be evaluated by a blinded to treatment group member of the medical staff at UHWI who is not involved in the study. Patients and families will be instructed to report any delayed complications, such as wound recurrence, noted within 3 months of study completion. All observed complications were mild pseudomonas infections, and all resolved with the application of dilute vinegar for fewer than two weeks.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

During the intervention, potential complications were assessed for presence at least weekly for 12 weeks

Results posted on

2023-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Practice (Negative Control) After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.
Overall Study STARTED	18	14	16
Overall Study COMPLETED	16	13	11
Overall Study NOT COMPLETED	2	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Practice (Negative Control) After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.
Overall Study Agreed to randomization, but withdrew when it did not lead to assignment to Group 2	1	0	1
Overall Study Lack of Efficacy	1	0	0
Overall Study No reliable phone and unable to come in weekly	0	1	1
Overall Study Unable to comply with protocol due to physical disability plus social isolation (no assistance)	0	0	1
Overall Study Intellectually disabled; caregivers neglected to follow protocol	0	0	1
Overall Study Emotionally unstable; (e.g.,data unreliable - completed four weeks' forms on day they were received)	0	0	1

Baseline Characteristics

Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Practice (Negative Control) n=16 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...), cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Total n=40 Participants Total of all reporting groups
Age, Continuous	37.4 years n=5 Participants	44.2 years n=7 Participants	47.9 years n=5 Participants	42.15 years n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	24 Participants n=4 Participants
Race/Ethnicity, Customized Jamaicans of West African descent	16 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	40 Participants n=4 Participants
Region of Enrollment Jamaica	16 participants n=5 Participants	13 participants n=7 Participants	11 participants n=5 Participants	40 participants n=4 Participants
Initial age of open Sickle Cell Leg Ulcer (SCLU), in weeks	402 weeks n=5 Participants	438 weeks n=7 Participants	363 weeks n=5 Participants	403 weeks n=4 Participants
Initial depth of study SCLU	3.94 millimeters n=5 Participants	5.54 millimeters n=7 Participants	4.09 millimeters n=5 Participants	4.50 millimeters n=4 Participants
Initial area of study SCLU	43 centimeters squared n=5 Participants	50.7 centimeters squared n=7 Participants	42 centimeters squared n=5 Participants	45.2 centimeters squared n=4 Participants
Mid-arm circumference indicates moderate malnutrition	7 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Initial Wound Quality of Life Scores	29.875 units on a scale n=5 Participants	41.385 units on a scale n=7 Participants	42.45 units on a scale n=5 Participants	40.825 units on a scale n=4 Participants
ASCQ-Me baseline scores Baseline ASCQ-Me Sickle-Cell Related Health History Scores (higher is worse)	19.9 units on a scale n=5 Participants	23.8 units on a scale n=7 Participants	19.3 units on a scale n=5 Participants	21.0 units on a scale n=4 Participants
ASCQ-Me baseline scores Baseline ASCQ-Me weekly domain score totals (raw scores, not converted to t-scores) (Lower is Worse)	85.2 units on a scale n=5 Participants	82.4 units on a scale n=7 Participants	78.0 units on a scale n=5 Participants	82.3 units on a scale n=4 Participants
Social isolation (lives alone without nearby support)	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Use of nicotine (e.g., smoking) in past week (yes/no)	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Education level, in years	11 years n=5 Participants	11 years n=7 Participants	9 years n=5 Participants	10.3 years n=4 Participants

PRIMARY outcome

Timeframe: During the intervention, potential complications were assessed for presence at least weekly for 12 weeks

If wound infection, healing impairing maceration, wound deterioration, etc. are suspected by the patient, the two blinded off-site observers viewing wound photos, or a member of the research study team, all dressings will be removed and the ulcer will be evaluated by a blinded to treatment group member of the medical staff at UHWI who is not involved in the study. Patients and families will be instructed to report any delayed complications, such as wound recurrence, noted within 3 months of study completion. All observed complications were mild pseudomonas infections, and all resolved with the application of dilute vinegar for fewer than two weeks.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=16 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Number of Participants Who Experienced a Wound Complication (A Measure of Dressing Safety)	4 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Measured at baseline and at 12 weeks.

Subtract the initial wound surface area from the final wound surface area. If the result is a positive number, the wound size remained the same or increased. If the number is negative, the wound size decreased. This is a dichotomous outcome.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=16 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Number of Participants Whose Wound Surface Area Decreased (A Measure of Effectiveness)	7 Participants	10 Participants	9 Participants	—	—

PRIMARY outcome

Timeframe: At final study visit, which took place after approximately 12 weeks of study participation.

Population: In addition to the study participants, the protocol required every family member and study team member who was involved in a participant's wound care to be asked the cultural acceptability question. Only 6 study participants had an involved family member, of whom 5 answered the acceptability question (one declined). In addition, 4 study team members participated in wound care and answered. The PI did not answer because as the developer of the improvised dressing, she has a conflict of interest.

Acceptable was defined in the study proposal as an average score of \> 4.0 Question: Does the study dressing's unconventional nature make it unacceptable to you? 5 point Likert scale (higher scores indicate increased acceptability): 5 - it is not a problem at all 4 - it is an unimportant problem 3 - it is a concern 2 - it is a serious problem 1 - it is so much of a problem that I would not use it

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=16 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members n=5 Participants Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) n=4 Participants Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Reported Cultural Acceptability of Available Technology (Improvised) Dressings	4.75 score on a scale Interval 3.0 to 5.0	5.0 score on a scale Interval 5.0 to 5.0	4.27 score on a scale Interval 3.0 to 5.0	4.6 score on a scale Interval 3.0 to 5.0	4.25 score on a scale Interval 3.0 to 5.0

PRIMARY outcome

Timeframe: Measured at baseline and weekly during the intervention, for 12 weeks. However, the change calculated here is only the difference between baseline and final (week 12) scores for the 5 parameters. Positive differences indicate improved scores.

The Adult Sickle Cell Quality of Life Measurement Information System tool (ASCQ-Me) Emotional, Pain, Social Functioning, Stiffness, and Sleep Impact Short Forms were administered by interview or self-administered (pencil \& paper). Each of these 5 forms is scored from 5 to 25, for a minimum of 25 and maximum of 125 total score. Higher scores indicate better self-reported overall sickle-cell disease-related health. (see Limitations) The tool developers expect results to be compared with a reference population whose T scores are provided in their guidance, but only the raw scores are reported here. Also, only the change in the means, from baseline to week 12 (the final scores), for the sum of the five parameters is reported here. This simple calculation does not account for outliers. A more detailed analysis can be requested from the researchers.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=16 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Change in Patient Overall Quality of Life: ASCQ-Me Questionnaire	7.516 score on a scale Interval -6.0 to 33.0	4.442 score on a scale Interval -19.0 to 39.0	15.045 score on a scale Interval -10.0 to 42.0	—	—

SECONDARY outcome

Timeframe: Measured at baseline and at the conclusion of the study, which is week 12.

Measured in cm2 electronically using software that automatically corrects for skew (HealthEPix). Due to the large number of study Sickle Cell Leg Ulcers that were at least partially circumferential, it was not possible to measure the wounds directly from photographs. The wound outlines were traced onto transparent plastic initially and at week 12. These tracings were measured using HealthEPix software, which also computed the wound surface area. The percent change in area was then calculated for each participant using Microsoft Excel (negative = improved). Because tracings were only collected initially and at week 12, it was not possible to obtain weekly ulcer size data. However, HealthEPix did provide accurate wound measurements (including area) from the tracings to allow an accurate calculation of the net change in wound surface area, from which percentage change was calculated. A negative number indicates the ulcer decreased in size.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=16 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Percent Change in Wound Surface Area From Baseline (A Measure of Effectiveness)	-1.647 % change in area Standard Deviation 59.184	-25.808 % change in area Standard Deviation 23.628	-36.071 % change in area Standard Deviation 44.465	—	—

SECONDARY outcome

Timeframe: Assessed Weekly. Closed by the end of the 12 week study period, or not closed by the end of the 12 week period. Verified 2 weeks later. This is a dichotomous variable.

Closed wound - 100% epithelialized with no discernible scab or exudate production (paper napkin remains dry when lightly pressed against area, and no recurrence in the subsequent two weeks), tested by a blinded UHWI physician (not a member of the study team). This outcome measure was modified from "wound closure time from initial assessment " because, due to the pandemic restrictions, participants were rarely able to come for closure verification on the exact week they appeared closed. No ulcers appeared closed before the final three weeks of the study. Two closures were verified on week 11 (group 1 and group 3) and one on week 12 (group 3). All were verified closed at 2 weeks - there were no instances of immediate recurrence.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=16 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Number of Participants Whose Wound Closed in 12 Weeks	1 Participants	0 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: At final study visit, which took place after approximately 12 weeks of study participation.

At the conclusion of the study, each participant was given a large quantity of dressing supplies from their choice of the three study protocols as a parting gift. The advanced dressings were unavailable in Jamaica outside of the study, and were the most expensive. The least expensive option was the study dressing (improvised) technique. The usual practice dressings were mid-range in cost and were the most familiar. Most of the participants had a long history of SCLUs (mean age of study ulcer was \>7 years), and these ulcers tend to recur, so they expected to require dressings for years to come.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=16 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Choice of Dressings After Study Completion (Which is a Proxy Measure for Dressing Acceptability) Chose usual practice supplies	2 Participants	1 Participants	2 Participants	—	—
Choice of Dressings After Study Completion (Which is a Proxy Measure for Dressing Acceptability) Chose improvised dressing supplies	5 Participants	8 Participants	3 Participants	—	—
Choice of Dressings After Study Completion (Which is a Proxy Measure for Dressing Acceptability) Chose advanced dressing supplies	9 Participants	4 Participants	6 Participants	—	—
Choice of Dressings After Study Completion (Which is a Proxy Measure for Dressing Acceptability) Number who kept same dressings	2 Participants	8 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: During the intervention, measured weekly for 12 weeks. Results were totaled for the entire study duration (12 weeks).

Lowest retail costs on Amazon.com were used for donated items, with actual costs for all other dressing materials. Often, participants did not limit the supply counts to those used on their study ulcer, providing instead a weekly total of all supplies used for all of their SCLUs (participants had 1 - 4 SCLUs). When weekly data was missing, it was extrapolated from data in adjacent weeks in which data was provided. Two participants (both in the usual practice group) did not provide any cost data.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=14 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Total Materials Costs in US Dollars	108.354 US Dollars Interval 7.28 to 556.56	55.76 US Dollars Interval 12.12 to 149.69	574.15 US Dollars Interval 81.81 to 2277.72	—	—

SECONDARY outcome

Timeframe: During the intervention, measured daily for all 12 weeks.

Estimated by each participant, in minutes, and recorded daily on a data sheet which they submitted weekly. Many participants included the time spent dressing all of their SCLUs, rather than only the study ulcer. The total number of minutes was tallied for each participant for each week. Weekly means were calculated for each participant and then for each group. The range is the range of the participant weekly means.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=15 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Average Number of Minutes/Week Spent Performing All Dressing Changes	153.356 minutes/week Interval 21.583 to 415.0	144.177 minutes/week Interval 21.0 to 266.5	86.497 minutes/week Interval 17.5 to 219.0	—	—

SECONDARY outcome

Timeframe: Scores were recorded by the participants daily throughout the study. Week 1 means were compared with week 12 means.

Persistent wound pain is wound pain that is present throughout the day, measured using the Faces Pain Scale - Revised (FPS-R), a 0 - 10 scale with 0 being the most desirable outcome. When daily data was missing, blanks were replaced with the average from the other days in the week. The means of scores from the final study week were subtracted from the means of scores from the initial study week, so if the change was an improvement, the value will be a positive number.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=16 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Change in Persistent Wound Pain: Faces Pain Scale - Revised (FPS-R)	4.314 score on a scale Interval 0.11 to 8.26	2.469 score on a scale Interval 0.02 to 7.23	3.36 score on a scale Interval 0.0 to 6.54	—	—

SECONDARY outcome

Timeframe: Scores were recorded by the participants daily throughout the study. Week 1 means were compared with week 12 means.

Pain that is the direct result of dressing changes, measured using the Faces Pain Scale - Revised (FPS-R), a 0 - 10 scale with 0 being the most desirable outcome. When daily data was missing, blanks were replaced with the average from the other days in the week. The means of scores from the final study week were subtracted from the means of scores from the initial study week, so if the change was an improvement, the value will be a positive number.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=15 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Procedural (Dressing Change) Wound Pain: Faces Pain Scale - Revised (FPS-R)	4.23 score on a scale Interval 0.0 to 8.4	2.61 score on a scale Interval 0.0 to 7.21	3.00 score on a scale Interval 0.0 to 6.32	—	—

SECONDARY outcome

Timeframe: Measured at baseline and weekly during the intervention, for 12 weeks. Only the change between the baseline score and the week 12 score is reported.

Assessed with the Wound-QoL tool, a self-assessment tool with 17 questions graded from 0 - 4, with 0 being the most desirable average outcome and 4 being the worst possible average outcome. Possible total scores range from 0 to 68. Sub-scales (body, psyche, and everyday life) can be evaluated independently (contact the researchers about obtaining that data, or for obtaining the weekly raw scores). Higher scores indicate worse SCLU-related quality of life. Final (week 12) total scores were subtracted from baseline total scores to calculate change in scores. If the change was an improvement, the number will be positive. Means for each group are given here.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=16 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Change in Patient Wound-specific Quality of Life: Wound-QoL Questionnaire	13.625 score on a scale Interval -19.0 to 38.0	7.692 score on a scale Interval -23.0 to 36.0	15.364 score on a scale Interval -20.0 to 53.0	—	—

SECONDARY outcome

Timeframe: During the intervention, recorded daily on the participants' weekly data sheet for the entire 12 week study period.

Approximate amount of time spent standing, or sitting with leg dependent without compression (mean of total hours per day). When daily data was missing, blanks were replaced with the average from the other days in the week. When an entire week was skipped, that participant's week was omitted from the calculations. The means of the daily means for each week for each participant for each group are reported here. Keeping the affected leg elevated when not using compression has been shown to dramatically improve SCLU healing. Therefore, a higher score on this outcome measure could be expected to lead to worse SCLU outcomes.

Outcome measures

Outcome measures
Measure	Usual Practice (Negative Control) n=15 Participants After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 Participants After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 Participants After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.	Involved Family Members Family member who has had some involvement with caring for the participant's wound. Maximum of one family member per participant. Surprisingly few family members were willing to have anything at all to do with the participants' wounds. Most either refused to even look at the wounds, or participants hid their wounds from them.	Involved Health Care Professional (Study Team Member) Due to the COVID-19 pandemic restrictions, many of the health care providers who expected to assist with the study were unable to do so. All of the team members who were actively involved in the wound dressing change process participated in the Acceptability question except for the PI, who abstained due to bias in favor of the dressing technique she developed.
Mean Number of Hours/Day the Wound Was Dependent	6.808 hours/day Interval 0.0 to 14.22	5.41 hours/day Interval 0.0 to 14.0	7.036 hours/day Interval 0.0 to 12.96	—	—

Adverse Events

Usual Practice (Negative Control)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Improvised Dressings (Experimental)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Advanced Dressings (Positive Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Usual Practice (Negative Control) n=16 participants at risk After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent. Usual Practice: A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Improvised Dressings (Experimental) n=13 participants at risk After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, ...cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change. Improvised dressing: A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.	Advanced Dressings (Positive Control) n=11 participants at risk After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present. Advanced dressing: A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.
Skin and subcutaneous tissue disorders Minor Pseudomonas infection	25.0% 4/16 • Number of events 4 • During the 12 week study period for each participant. Blinded off site observers and the research team observed photos of wounds weekly and participants were advised to come in for an evaluation if there was any evidence of infection or healing-delaying maceration. Wounds were also assessed in person every 4 weeks.	0.00% 0/13 • During the 12 week study period for each participant. Blinded off site observers and the research team observed photos of wounds weekly and participants were advised to come in for an evaluation if there was any evidence of infection or healing-delaying maceration. Wounds were also assessed in person every 4 weeks.	0.00% 0/11 • During the 12 week study period for each participant. Blinded off site observers and the research team observed photos of wounds weekly and participants were advised to come in for an evaluation if there was any evidence of infection or healing-delaying maceration. Wounds were also assessed in person every 4 weeks.

Additional Information

Linda Benskin, PhD, RN, Independent Researcher

BenskinL

Phone: +1 (512) 659-0812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place