Altrazeal™ Versus Aquacel® Ag for Partial Thickness Skin Donor Sites
The primary objective of the study is to evaluate the time to wound healing in skin graft donor sites with a new treatment (Altrazeal dressing) compared to standard of care treatment (Aquacel Ag- Carboxymethylcellulose dressing) in partial thickness skin graft donor sites.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Comparison Study of a Flexible HydrogelNanoparticle Wound Dressing (Altrazeal) Versus a Sodium Carboxymethylcellulose Dressing (Aquacel Ag) as Dressings for Partial Thickness Skin Graft Donor Sites|
- Time to wound healing (re-epithelialization), in days assessed by the physician according to the study center's Standard of Care, for each wound dressing. [ Time Frame: 24 days ] [ Designated as safety issue: No ]
- Patient's comfort [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
- Patient's pain [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
- Infections [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
This is a single center, randomized, therapeutic exploratory study to monitor wound healing with the new AltrazealTM flexible hydrogel nanoparticle dressing compared to the existing treatment standard (Aquacel ® AG sodium carboxymethylcellulose dressing) in patients with at least two skin graft donor sites. 40 patients with at least 2 skin graft donor sites, ranging in age from 3 and 85 years, will be enrolled. Children (age 3 to 16 inclusive) will be included in the patient population if possible, but should not exceed 50% of all patient enrolled. Researchers will first identify the skin donor sites (A and B) for each patient and take baseline digital images and measurements immediately following surgery (Day 1). Trained personnel will apply the dressings provided by the Sponsor for and labeled as A or B by the Sponsor in a random fashion. Typical meticulous wound care and adequate analgesic medical coverage will be provided for the duration of the study. Both the patient and medical staff will be trained on instructions for use of each dressing. The patients will be monitored daily as part of standard procedure while they are in the in-patient setting. If and when patients move to the out-patient setting, they will continue to be monitored at least every-other-day at the study center. On each day (in-patient) or every-other-day (outpatient), the physician will determine whether each skin graft donor site has healed per standard care guidelines (i.e. > 95% re-epithelization), and pain and adverse events will be monitored. The last study visit will be on Day 24 or on the day when both wounds have been assessed as "healed", whichever comes first.