A Test of Different Kinds of Bandages on Healing of Wounds
Condition: Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

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.
    

Intervention name(s): 6660; 4314; 8336; 4840
Intervention type(s): Device; Device; Device; Device
Intervention description(s): At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.; At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.; At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.; At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
Other intervention name(s): Sheer Strips; BAND-AID® with QuiltVent™ Pad Technology; Flexible Fabric; BAND-AID® with QuiltVent™ Pad Technology; Tough Strips® Waterproof; BAND-AID® with QuiltVent™ Pad Technology; Flat Pad; BAND-AID® Dora the Explorer™
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Keywords: Adhesive Bandages; Dermabrasion Wounds