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

NCT ID: NCT04479618

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-06
• Study Completion Date: 2022-02-20

Brief Summary

One in 300 Jamaicans have HbSS sickle cell disease, and of these, up to 70% will suffer from sickle cell leg ulcers (SCLUs). Of these, 24% will have a chronic SCLU (one lasting longer than 6 months). SCLUs heal very slowly, and sometimes they never close. SCLU patients would benefit from an economical, less painful, dressing option. In addition, because SCLUs often compromise education and employment opportunities, improving wound care for this population benefits their entire community.

This three-armed evaluator-blinded randomized controlled trial will determine if a cut-to-fit food-grade plastic-based improvised dressing decreases pain, improves quality of life, and is safe, effective, and acceptable for managing SCLUs in Jamaica. The negative control will be usual practice, and the positive control will be the advanced wound dressing with the strongest evidence supporting its use in a tropical climate (polymeric membrane dressing).

Patients with SCLUs will be actively recruited from three adjacent parishes. The first 120 SCLU patients meeting study criteria presenting to UHWI, Mona, will be randomized immediately after initial cleansing/debriding into group (1) current usual practice, group (2) improvised dressings, or group (3) advanced dressings. Data will be added to each participant's data collection tool weekly. Results will be reported using descriptive statistics and ANCOVA. The expected outcome is both improvised and advanced dressing superiority to usual practice.

Because proposed improvised dressing materials are easily obtainable, their use would increase the capacity of wound patients to safely and effectively care for themselves.

Signed informed consent will be obtained from patients/parents. Only principal research investigators will have access to participant confidential information. The literature review demonstrates that risks are not higher than usual practice.

Detailed Description

This study's primary purpose is to determine if an improvised dressing, made from inexpensive materials available for purchase in rural as well as urban settings, is a safe and effective, culturally and medically acceptable choice for managing sickle cell leg ulcers in a tropical climate. Three research questions will be addressed:

1. Is the improvised dressing, consisting of a cut-to-fit new plastic bag sealed at the periwound with zinc oxide paste, safe and effective (see definitions, below) when compared with usual practice (saline-soaked gauze) and when compared with an advanced wound dressing (PMD), on sickle cell leg ulcers (SCLUs) in Jamaica?

2. Does use of the improvised dressing, when compared with usual practice, improve the quality of life of patients (decrease pain, increase ability to engage in desirable activities, decrease wound-related materials costs, decrease time required to perform dressing changes, improve Wound QoL scores, and improve ASCQ-Me pencil-and-paper interview scores) with SCLUs in Jamaica?

3. Is the improvised dressing culturally acceptable to health care providers, patients, and families for managing SCLUs in Jamaica?

The expected study outcome is improvised dressing superior effectiveness and quality of life, when compared with usual practice, without increased safety and acceptability issues. The improvised dressing is likely to be the least expensive choice, with the added benefit of being available as first aid treatment throughout Jamaica. The advanced dressing is likely to be more expensive with respect to materials costs, although fewer dressing changes are anticipated and pain medication expenses are likely to be reduced. Based upon the review of the literature, no serious infections or other safety issues are anticipated for any group. However, to ensure that complications are not overlooked, in addition to the onsite researchers' vigilance, weekly wound photos will be assessed for complications (signs of infection, wound deterioration, or clinically relevant maceration) by two off-site blinded wound experts.

Definitions:

Sickle cell leg ulcer - a wound in a HbSS or HbSβ0 positive patient, open greater than one month, below the level of the knee excluding the plantar surface of the foot.

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)

Safe - infection and other complications (healing-impairing maceration, keloid, and contracture rates) not statistically significantly higher than usual practice, with no major adverse events attributable to the method

Effective - ulcer closure rates or ulcer surface area reduction rates not statistically significantly lower than usual practice

Acceptable - average acceptability scores of 4 or higher on a 1 - 5 scale

Conditions

Sickle Cell Leg Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Usual Practice

Intervention Type: DEVICE

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, purchased from the Papine Market across John Golding Road from the University of the West Indies), 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.

Group Type: EXPERIMENTAL

Improvised dressing

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Advanced dressing

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Saline Gauze; Wrap Therapy (modified for a tropical environment); Polymeric membrane dressings; PolyMem

Eligibility Criteria

Inclusion Criteria

• Diagnosed with HbSS or HbSβ0 sickle cell disease
• Ages 13 - 70 years at study initiation (able to comprehend and give consent)
• Males and females, pregnancy is not an issue
• Open wound below the knee, not including the plantar surface of the foot
• Wound open for longer than one month (defined as a chronic SCLU)
• Traumatic, spontaneous, or recurrent SCLU (all etiologies)

Exclusion Criteria

• Patient younger than 13 years of age at study initiation
• Patient older than 70 years of age at study initiation
• Wound open for less than one month by conclusion of study enrollment period (acute wounds could be traumatic wounds unrelated to sickle cell diagnosis)
• Diagnosis of cancer, hypertension, or chronic renal failure
• Diabetes (will screen for undiagnosed diabetes)
• Active wound infection (evidenced by clinical signs of malodor, dark-colored or thick drainage, or significantly increased warmth at the periwound) which is not resolved by the conclusion of the study enrollment period
• Osteomyelitis (if osteomyelitis is suspected, an ESR will be drawn; > 70mm/h with high platelet levels and low serum albumin warrants a bone biopsy)
• Hydroxyurea use (may be a confound because it reduces inflammation and negates much of the pathology of SSD - may choose to abstain for the study)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wound Healing Foundation

OTHER

Sponsor Role: collaborator

University Hospital of the West Indies

OTHER

Sponsor Role: collaborator

The University of The West Indies

OTHER

Sponsor Role: collaborator

Ferris Mfg. Corp.

INDUSTRY

Sponsor Role: collaborator

Benskin, Linda, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA

OTHER

Sponsor Role: lead

Responsible Party

Linda Benskin

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda L Benskin, PhD

Role: PRINCIPAL_INVESTIGATOR

Independent Nurse Researcher for Rural Tropical Areas, AND Ferris Mfg. Corp.

Rajeev Venugopal, MBBS

Role: STUDY_CHAIR

Consultant Plastic Surgeon, University Hospital of the West Indies

Locations

University Hospital of the West Indies

Mona, Kingston, Jamaica

Countries

Jamaica

References

Benskin LL. A review of the literature informing affordable, available wound management choices for rural areas of tropical developing countries. Ostomy Wound Manage. 2013 Oct;59(10):20-41.

Reference Type: BACKGROUND

PMID: 24106254 (View on PubMed)

Benskin LLL. Discovering the Current Wound Management Practices of Rural Africans [Dissertation]. 2013. Available from: http://utmb-ir.tdl.org/handle/2152.3/538

Reference Type: BACKGROUND

Scientific and Clinical Abstracts From WOCNext(R) 2022: Fort Worth, Texas diamond June 5-8, 2022. J Wound Ostomy Continence Nurs. 2022 May-Jun 01;49(3 Suppl 1):S1-S99. doi: 10.1097/WON.0000000000000882. No abstract available.

Reference Type: DERIVED

PMID: 35639023 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

SCLUJamaica2020

Identifier Type: -

Identifier Source: org_study_id