A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings

July 19, 2018 updated by: University of California, Irvine

A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings With Regards to Healing Time, Cosmesis, Infection Rate, and Patient's Perceived Pain: a Pilot Study.

The research will be looking at patient outcomes for healing of donor sites after a split-thickness skin graft procedure for a burn or skin tissue loss. Donor site healing time, infection rate, cosmetic outcome, and patient's rating of pain will be compared between two donor site dressings, Glucan II and Aquacel Ag.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

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
    • California
      • Orange, California, United States, 92868
        • University of California Irvine 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Burn injured patients or patients who have had full thickness skin loss requiring skin grafting and donor site dressings

Description

Inclusion Criteria:

  • Adults over age 18 who have sustained a 1 - 30% total body surface area burn or skin tissue loss and require skin grafting

Exclusion Criteria:

  • Individuals under the age of 18.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single arm study
Burn patients or patients with skin loss requiring split-thickness skin graft
Other: Aquacel Ag
Aquacel Ag will be applied to one donor site.
Other: Glucan II
Glucan II to be applied to a donor site on same patient for comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healing time
Time Frame: 7 - 14 days
7 - 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Infection rate
Time Frame: 1-21 days
1-21 days
Cosmetic outcome
Time Frame: 6 months
6 months
Pain rating
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Marianne E Cinat, MD, University of California, Irvine
  • Principal Investigator: Suzanne Bailey, PT, University of California, Irvine
  • Principal Investigator: Melissa Carmean, PT, CWS, BS, University of California, Irvine

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

December 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

December 27, 2007

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-4881

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.

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