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

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ClinicalTrials.gov Identifier: NCT00581217
Recruitment Status : Unknown
Verified May 2010 by University of California, Irvine.
Recruitment status was:  Active, not recruiting
First Posted : December 27, 2007
Last Update Posted : May 13, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Burns Other: Aquacel Ag Other: Glucan II

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Study Start Date : December 2007
Primary Completion Date : March 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Healing time [ Time Frame: 7 - 14 days ]

Secondary Outcome Measures :
  1. Infection rate [ Time Frame: 1-21 days ]
  2. Cosmetic outcome [ Time Frame: 6 months ]
  3. Pain rating [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581217


Locations
United States, California
University of California Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
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
More Information

Responsible Party: Marianne Cinat, MD, FACS, University of California Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00581217     History of Changes
Other Study ID Numbers: 2006-4881
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: May 13, 2010
Last Verified: May 2010

Keywords provided by University of California, Irvine:
Burn injury
Skin graft
Donor site dressing
Outcomes
Infection rate
Healing time
Cosmetic Result
Pain
Burn injured patients requiring skin grafting

Additional relevant MeSH terms:
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents