N/A
N=46
A Test of Different Kinds of Bandages on Healing of Wounds
Wound Healing
Bottom Line
View on ClinicalTrials.gov: NCT01770860 ↗Enrolled (actual)
46
Serious AEs
2.2%
Results posted
Aug 2014
Primary outcome: Primary: Time to Healing (Days) — 13.1; NA; 13.1; NA days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 6660 (Device); 4314 (Device); 8336 (Device); 4840 (Device)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Healing (Days) |
13.1; NA; 13.1; NA; NA | — |
| SECONDARY Forced Rank Score |
1.48; 3.04; 2.44; 3.77; 3.29 | <0.0001 sig |
| SECONDARY Erythema |
1.74; 0.90; 0.90; 0.97; 0.88 | <0.0001 sig |
| SECONDARY Edema |
1.44; 0.57; 0.69; 0.56; 0.64 | <0.0001 sig |
| SECONDARY Maceration |
4.37; 70.98; 65.21; 39.34; 63.99 | <0.0001 sig |
| SECONDARY Subjective Assessment of Pain |
5.24; 4.55; 2.45; 3.85; 2.45 | 0.0476 sig |
| SECONDARY Subjective Assessment of Itch |
21.33; 26.22; 16.43; 25.87; 20.10 | — |
| SECONDARY Subjective Assessment of Wound Healing |
22; 20; 14; 30; 26 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01770860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.