Clinical trial NCT00731367: Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites
Official title: A Phase IIIb, Randomized Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Split-Thickness Donor Sites.
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-08-11
Enrollment: 73
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To evaluate the proportion of subjects healed.
timeFrame: 14 days
Secondary outcomes:
measure: Time to healing.
timeFrame: 14 days
measure: Degree of pain at dressing change.
timeFrame: 14 days
measure: Degree of pain/discomfort while wearing the dressing at rest and during mobility.
timeFrame: 14 days
measure: Investigator's rating of dressing performance (per subject and overall).
timeFrame: 14 days
measure: Resources utilization.
timeFrame: 14 days
measure: Readiness for re-harvesting.
timeFrame: day 14
measure: Safety.
timeFrame: 14 days +30
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
Study officials:
affiliation: Maricopa Medical Center
name: Daniel Caruso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blome-Eberwein S, Johnson RM, Miller SF, Caruso DM, Jordan MH, Milner S, Tredget EE, Sittig KM, Smith L. Hydrofiber dressing with silver for the management of split-thickness donor sites: a randomized evaluation of two protocols of care. Burns. 2010 Aug;36(5):665-72. doi: 10.1016/j.burns.2009.06.193. Epub 2009 Dec 6.