NCT01770860

A Test of Different Kinds of Bandages on Healing of Wounds

An Assessment of QuiltVent™ Pad Technology on the Healing of Induced Dermabrasion Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. · Industry
• Sex: All
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is evaluating the performance of various bandages on facilitating the healing of induced dermabrasion wounds. To qualify for this study, subjects must meet the inclusion/exclusion criteria within the protocol-specified parameters at both the screening and baseline visits. Once a subject is qualified, 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 and one wound will be left open to the air to serve as a no treatment control. Treatments and control will be randomized to application site. During this 14-day clinical study, subjects will return to the site for daily evaluations; study bandages will also be replaced daily by study personnel. Adverse events will be observed and collected by querying each subject at each visit, and during any follow-up period.

Conditions

• Wound Healing

Interventions

Type	Name	Description
DEVICE	6660	At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
DEVICE	4314	At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
DEVICE	8336	At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
DEVICE	4840	At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-01-18
• Last updated: 2014-08-04
• Results posted: 2014-08-04

Locations

1 site across 1 country: United States