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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of California, Irvine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581217
First received: December 21, 2007
Last updated: May 11, 2010
Last verified: May 2010
  Purpose

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 Intervention
Burns
Other: Aquacel Ag
Other: Glucan II

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Healing time [ Time Frame: 7 - 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infection rate [ Time Frame: 1-21 days ] [ Designated as safety issue: No ]
  • Cosmetic outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pain rating [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2007
Estimated Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 21, 2007
Last Updated: May 11, 2010
Health Authority: United States: Institutional Review Board

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:
Burns
Wounds and Injuries
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014