Trial Outcomes & Findings for A Test of Different Kinds of Bandages on Healing of Wounds (NCT NCT01770860)

NCT ID: NCT01770860

Last Updated: 2014-08-04

Results Overview

Wound epithelialization will be recorded daily for each wound (until healed) by the doctor on a scale of 0-5, where 0= No presence of epithelialization (no sign of healing), a bandage is necessary and 5=Wound is 100% epithelialized (healed), no bandage necessary. The median time to healing will be estimated from the survival curves using the Kaplan-Meier method for each test product. Time to healing is defined as the time from wounding to 12:00 pm of the day the wound is 100% epithelialized (receives a score of 5). If the wound is not 100% epithelialized on Day 14 or on the last day of visit, Time to healing will be considered as censored.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: within 14 days
• Results posted on: 2014-08-04

Participant Flow

One additional subject was enrolled but withdrew before randomization.

Participant milestones

Measure	4 Commercially-available Bandage and 1 Control Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
Overall Study STARTED	46
Overall Study Randomization	45
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	4 Commercially-available Bandage and 1 Control Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	1
Overall Study Administrative decision made by the PI	1

Baseline Characteristics

A Test of Different Kinds of Bandages on Healing of Wounds

Baseline characteristics by cohort

Measure	4 Commercially-available Bandage and 1 Control n=45 Participants Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
Age, Continuous	44.4 years STANDARD_DEVIATION 7.47 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants
Fitzpatrick Skin Classification Fitzpatrick Skin Classification - II	11 participants n=5 Participants
Fitzpatrick Skin Classification Fitzpatrick Skin Classification - III	34 participants n=5 Participants

PRIMARY outcome

Timeframe: within 14 days

Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. Forty six subjects were enrolled but one withdrew before randomization.

Wound epithelialization will be recorded daily for each wound (until healed) by the doctor on a scale of 0-5, where 0= No presence of epithelialization (no sign of healing), a bandage is necessary and 5=Wound is 100% epithelialized (healed), no bandage necessary. The median time to healing will be estimated from the survival curves using the Kaplan-Meier method for each test product. Time to healing is defined as the time from wounding to 12:00 pm of the day the wound is 100% epithelialized (receives a score of 5). If the wound is not 100% epithelialized on Day 14 or on the last day of visit, Time to healing will be considered as censored.

Outcome measures

Measure	Bandage QuiltVent™ Sheer Strips (With Pad Removed) n=45 Participants No treatment	Bandage QuiltVent™ Sheer Strips n=45 Participants	Bandage QuiltVent™ Flexible Fabric n=45 Participants	Bandage QuiltVent™ Tough Strips Waterproof n=45 Participants	Bandage Dora the Explorer™ n=45 Participants
Time to Healing (Days)	13.1 days Interval 12.95 to 13.14	NA days Due to the censoring status of the data, the median time to healing could not be estimated	13.1 days Interval 13.05 to 13.15	NA days Interval 10.9 to Due to the censoring status of the data, the median time to healing could not be estimated	NA days Due to the censoring status of the data, the median time to healing could not be estimated

SECONDARY outcome

Timeframe: within 14 days

Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.

The wound evaluator will rank the overall appearance of all five wounds in relation to each other on a daily basis until all five are healed on a scale of 1 to 5, where 1= Worst and 5=Best. The forced Rank was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.

Outcome measures

Measure	Bandage QuiltVent™ Sheer Strips (With Pad Removed) n=44 Participants No treatment	Bandage QuiltVent™ Sheer Strips n=44 Participants	Bandage QuiltVent™ Flexible Fabric n=44 Participants	Bandage QuiltVent™ Tough Strips Waterproof n=44 Participants	Bandage Dora the Explorer™ n=44 Participants
Forced Rank Score	1.48 scores on a scale Standard Deviation 0.58	3.04 scores on a scale Standard Deviation 0.90 • Interval 1.24 to 1.88	2.44 scores on a scale Standard Deviation 0.95 • Interval 0.65 to 1.28	3.77 scores on a scale Standard Deviation 1.01 • Interval 1.97 to 2.61	3.29 scores on a scale Standard Deviation 0.95 • Interval 1.5 to 2.13

SECONDARY outcome

Timeframe: within 14 days

Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.

Until healed, erythema (redness) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Erythema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed here using a mixed model.

Outcome measures

Measure	Bandage QuiltVent™ Sheer Strips (With Pad Removed) n=44 Participants No treatment	Bandage QuiltVent™ Sheer Strips n=44 Participants	Bandage QuiltVent™ Flexible Fabric n=44 Participants	Bandage QuiltVent™ Tough Strips Waterproof n=44 Participants	Bandage Dora the Explorer™ n=44 Participants
Erythema	1.74 scores on a scale Standard Deviation 0.64	0.90 scores on a scale Standard Deviation 0.42 • Interval -1.02 to -0.67	0.90 scores on a scale Standard Deviation 0.49 • Interval -1.01 to -0.66	0.97 scores on a scale Standard Deviation 0.48 • Interval -0.94 to -0.59	0.88 scores on a scale Standard Deviation 0.43 • Interval -1.03 to -0.68

SECONDARY outcome

Timeframe: within 14 days

Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.

Until healed, edema (swelling) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Mean Edema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.

Outcome measures

Measure	Bandage QuiltVent™ Sheer Strips (With Pad Removed) n=44 Participants No treatment	Bandage QuiltVent™ Sheer Strips n=44 Participants	Bandage QuiltVent™ Flexible Fabric n=44 Participants	Bandage QuiltVent™ Tough Strips Waterproof n=44 Participants	Bandage Dora the Explorer™ n=44 Participants
Edema	1.44 scores on a scale Standard Deviation 0.52	0.57 scores on a scale Standard Deviation 0.38	0.69 scores on a scale Standard Deviation 0.43	0.56 scores on a scale Standard Deviation 0.42	0.64 scores on a scale Standard Deviation 0.39

SECONDARY outcome

Timeframe: within 14 days

Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.

Until healed, maceration (a slight whitening of the skin around the wound compared to the surrounding unbandaged area) will be scored as P=Present or A=Absent. Percentage of maceration was derived as the maceration presence times over study period divided by visit number 13.

Outcome measures

Measure	Bandage QuiltVent™ Sheer Strips (With Pad Removed) n=44 Participants No treatment	Bandage QuiltVent™ Sheer Strips n=44 Participants	Bandage QuiltVent™ Flexible Fabric n=44 Participants	Bandage QuiltVent™ Tough Strips Waterproof n=44 Participants	Bandage Dora the Explorer™ n=44 Participants
Maceration	4.37 percentage of maceration Standard Deviation 9.15	70.98 percentage of maceration Standard Deviation 22.12	65.21 percentage of maceration Standard Deviation 23.43	39.34 percentage of maceration Standard Deviation 31.88	63.99 percentage of maceration Standard Deviation 26.64

SECONDARY outcome

Timeframe: within 14 days

Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.

Until healed, pain assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of pain was derived as the pain presence times over study period divided by visit number 13.

Outcome measures

Measure	Bandage QuiltVent™ Sheer Strips (With Pad Removed) n=44 Participants No treatment	Bandage QuiltVent™ Sheer Strips n=44 Participants	Bandage QuiltVent™ Flexible Fabric n=44 Participants	Bandage QuiltVent™ Tough Strips Waterproof n=44 Participants	Bandage Dora the Explorer™ n=44 Participants
Subjective Assessment of Pain	5.24 percentage of pain Standard Deviation 12.39	4.55 percentage of pain Standard Deviation 10.13	2.45 percentage of pain Standard Deviation 6.38	3.85 percentage of pain Standard Deviation 7.87	2.45 percentage of pain Standard Deviation 5.69

SECONDARY outcome

Timeframe: within 14 days

Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.

Until healed, itch assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of itch was derived as the itch presence times over study period divided by visit number 13.

Outcome measures

Measure	Bandage QuiltVent™ Sheer Strips (With Pad Removed) n=44 Participants No treatment	Bandage QuiltVent™ Sheer Strips n=44 Participants	Bandage QuiltVent™ Flexible Fabric n=44 Participants	Bandage QuiltVent™ Tough Strips Waterproof n=44 Participants	Bandage Dora the Explorer™ n=44 Participants
Subjective Assessment of Itch	21.33 percentage of itching Standard Deviation 28.24	26.22 percentage of itching Standard Deviation 29.46	16.43 percentage of itching Standard Deviation 21.73	25.87 percentage of itching Standard Deviation 26.24	20.10 percentage of itching Standard Deviation 22.15

SECONDARY outcome

Timeframe: within 14 days

Population: The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.

Until healed, subjects will be shown photographs of each wound they have not previously classified as healed at each daily visit, and asked to determine if the wound is healed. Yes or No responses will be recorded, along with text entries of the reasons for the response. This outcome measure reports the number of subjects who report that the wound has healed.

Outcome measures

Measure	Bandage QuiltVent™ Sheer Strips (With Pad Removed) n=44 Participants No treatment	Bandage QuiltVent™ Sheer Strips n=44 Participants	Bandage QuiltVent™ Flexible Fabric n=44 Participants	Bandage QuiltVent™ Tough Strips Waterproof n=44 Participants	Bandage Dora the Explorer™ n=44 Participants
Subjective Assessment of Wound Healing	22 Participants	20 Participants	14 Participants	30 Participants	26 Participants

Adverse Events

4 Commercially-available Bandage and 1 Control

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure

4 Commercially-available Bandage and 1 Control n=46 participants at risk Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.

Infections and infestations Bronchopneumonia

2.2% 1/46 • 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events. The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event. Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.

Other adverse events

Measure	4 Commercially-available Bandage and 1 Control n=46 participants at risk Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
Nervous system disorders Headache	13.0% 6/46 • 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events. The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event. Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.
Injury, poisoning and procedural complications Excoriation	2.2% 1/46 • 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events. The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event. Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.
Injury, poisoning and procedural complications Laceration	2.2% 1/46 • 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events. The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event. Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.
Injury, poisoning and procedural complications Ligament Sprain	2.2% 1/46 • 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events. The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event. Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.
Respiratory, thoracic and mediastinal disorders Dysphonia	2.2% 1/46 • 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events. The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event. Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	2.2% 1/46 • 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events. The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event. Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Congestion	2.2% 1/46 • 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events. The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event. Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.
Infections and infestations Tooth Abscess	2.2% 1/46 • 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events. The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event. Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.
General disorders Influenza Like Illness	2.2% 1/46 • 30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events. The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event. Adverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.

Additional Information

Associate Director, Clinical Research

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Phone: 973-385-7984

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60