Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites

Study Overview
=================
Brief Summary
-----------------
This phase IIIb, randomized, comparative, multi-center study is designed to evaluate two AQUACEL Ag protocols of care for the management of split-thickness donor sites. Both protocols of care will utilize AQUACEL Ag as the primary dressing. As per the randomization assignment, one protocol of care will have the AQUACEL Ag initially covered with a gauze dressing to create an adherent state and in the other protocol of care the AQUACEL Ag will be covered with a transparent film to maintain a gelled state. The primary objective of the study will be to quantify the proportion of subjects healed at 14 days. Secondary objectives will include: time to healing, degree of pain at dressing change and while wearing the dressing, simplicity of use, resources used in treatment and safety. Approximately 68 subjects will be enrolled from 10 centers from within the US and Canada.

Official Title
-----------------
A Phase IIIb, Randomized Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites.

Conditions
-----------------
Split-Thickness Donor Sites.

Intervention / Treatment
-----------------
* Device: Aquacel Ag Gelled
* Device: Aquacel Ag Adherent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject or legally authorized representative must provide written informed consent. Subject who is younger than legal consenting age must have a legally authorized representative who will provide written informed consent. The subject is scheduled to undergo a split-thickness skin graft (autograft) Harvesting of the donor site must be limited to the location and size of the anterior thigh The selected anterior thigh must be a first - time harvesting. Exclusion Criteria: Subjects with known skin sensitivity to any of the dressing components. Subjects who require a full thickness graft. The subject with a poor prognosis, which would make it unlikely that he/she would survive the 21 day study period. Subjects who have been previously randomized into the study, or who are presently participating in another clinical trial.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gelled<br>Aquacel Ag gelled. | Device: Aquacel Ag Gelled<br>* AQUACEL Ag is produced by changing a small fraction of the sodium ions present in AQUACEL for silver ions and then stabilizing the complex formed by adding chloride. This produces a characteristic silver gray product. There are no counter ions (such as nitrate or sulphadiazine ions) present: these compounds, found in many silver containing products, are known to retard wound healing. AQUACEL Ag maintains a moist wound-healing environment while, at the same time, killing wound pathogens that are immobilized within the dressing. It also reduces bioburden at the wound-dressing surface, thus minimizing the risk of wound infection and facilitating wound healing.<br>|
| Active Comparator: Adherent<br>Aquacel Ag adherent | Device: Aquacel Ag Adherent<br>* AQUACEL Ag is produced by changing a small fraction of the sodium ions present in AQUACEL for silver ions and then stabilizing the complex formed by adding chloride. This produces a characteristic silver gray product. There are no counter ions (such as nitrate or sulphadiazine ions) present: these compounds, found in many silver containing products, are known to retard wound healing. AQUACEL Ag maintains a moist wound-healing environment while, at the same time, killing wound pathogens that are immobilized within the dressing. It also reduces bioburden at the wound-dressing surface, thus minimizing the risk of wound infection and facilitating wound healing.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the proportion of subjects healed. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing. |  | 14 days | 
| Degree of pain at dressing change. |  | 14 days | 
| Degree of pain/discomfort while wearing the dressing at rest and during mobility. |  | 14 days | 
| Investigator's rating of dressing performance (per subject and overall). |  | 14 days | 
| Resources utilization. |  | 14 days | 
| Readiness for re-harvesting. |  | day 14 | 
| Safety. |  | 14 days +30 |