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

February 2, 2009 updated by: ConvaTec Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gelled
Aquacel Ag gelled.
Device: Aquacel Ag Gelled
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.
Active Comparator: Adherent
Aquacel Ag adherent
Device: Aquacel Ag Adherent
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the proportion of subjects healed.
Time Frame: 14 days
14 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConvaTec Inc.

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Daniel Caruso, MD, Maricopa Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

February 3, 2009

Last Update Submitted That Met QC Criteria

February 2, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CW-0412-05-A080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Split-Thickness Donor Sites.

Clinical Trials on Aquacel Ag Gelled

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe