A Test of Different Kinds of Bandages on Healing of Wounds

NCT01770860 | Completed Results

• 1 other identifier: ABDWDP0005
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This two-week study will compare the healing of minor wounds when no bandage is applied against four different types of bandages. The study investigators will make five small wounds similar to scrapes (about a half-inch square) on the back of subjects who qualify to participate in the trial and have given informed consent. Four of the wounds will be covered by different bandages and one will be left uncovered. Participants will visit the clinic every day for 2 weeks or until all the wounds are healed (whichever comes first). At the clinic, the bandages will be removed, the doctor will score the wounds, a picture will be taken of the wounds and new bandages will be applied. It is expected that some pain and itching will be experienced, because they are part of the normal wound healing process. Subjects will be asked about adverse events at each visit and will have the opportunity to discuss issues or concerns with the investigator or the doctor during the course of the trial. It is expected that the wounds will be completely healed within 14 days, but if not, the participant will need to return to the clinic for follow-up treatment until the wounds are completely healed. We will see if the different bandages help with the healing of the wounds during the study.

Conditions

Wound Healing

Keywords

Adhesive Bandages; Dermabrasion Wounds

Outcome Measures

Primary Outcomes (1)

• Time to Healing (Days)

  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.

  within 14 days

Secondary Outcomes (7)

• Forced Rank Score

  within 14 days

• Erythema

  within 14 days

• Edema

  within 14 days

• Maceration

  within 14 days

• Subjective Assessment of Pain

  within 14 days

Study Arms (5)

6660

ACTIVE COMPARATOR

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.

Device: 6660

4314

ACTIVE COMPARATOR

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.

Device: 4314

8336

ACTIVE COMPARATOR

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.

Device: 8336

4840

PLACEBO COMPARATOR

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.

Device: 4840

0000

NO INTERVENTION

Device: 0000 At each daily visit, designated study personnel will cut out the center pad of the bandage and apply only the adhesive tabs around the assigned wound site. Other Names: * Sheer Strips * BAND-AID® with QuiltVent™ Pad Technology 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.

Interventions

6660 DEVICE

At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.

Also known as: Sheer Strips, BAND-AID® with QuiltVent™ Pad Technology

6660

4314 DEVICE

At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.

Also known as: Flexible Fabric, BAND-AID® with QuiltVent™ Pad Technology

4314

8336 DEVICE

At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.

Also known as: Tough Strips® Waterproof, BAND-AID® with QuiltVent™ Pad Technology

8336

4840 DEVICE

At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.

Also known as: Flat Pad, BAND-AID® Dora the Explorer™

4840

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be able to read and understand English enough to understand the nature, risk and relevance of the study, read and sign the informed consent document, and follow study instructions
• After being completely informed about the study and being given a chance to have all questions answered, the subject has signed an informed consent document agreeing to:
• comply with lifestyle instructions, including: limiting bandage exposure to water or sunlight, the use of lotions, creams, cosmetics or sunscreens during the study, to allow at least 2 hours between showers and scheduled visits, and the use of contraception
• return to the clinical site for follow-up visits if the wounds are not healed by Day 14
• Subject is determined to be an appropriate participant according to protocol-defined conditions, including among other things, Body Weight and Fitzpatrick Skin Type between I (Always burns easily, never tans) and III (Burns moderately, tans gradually)
• In the opinion of the Investigator, participation in the trial will not compromise the subject's safety or the interpretation of study results

You may not qualify if:

• Medical condition or history, or use of drugs or treatments that could possibly compromise the safety of the research subject or the interpretation of results, per protocol or in the opinion of the investigator
• Known allergies or hypersensitivity to LATEX, anesthetics, adhesive bandages, wound treatment products or any component present in the test bandages
• Current participation in any other clinical trial or past participation in other clinical trials described in the protocol
• Body mass index (BMI) above 35, and/or Fitzpatrick Skin Type above III
• Pregnant, nursing or planning a pregnancy

Sponsors & Collaborators

• Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.: lead

Study Sites (1)

Hill Top Research

St. Petersburg, Florida, 33710, United States

Location

Results Point of Contact

• Title: Associate Director, Clinical Research
• Organization: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

973-385-7984

Study Officials

• Clare Kendall

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 18, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 4, 2014
• Results First Posted: August 4, 2014

Record last verified: 2014-07

Locations

US (1)