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TerminatedNCT00581217Updated Jul 23, 2018

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

An observational study in Burns, sponsored by University of California, Irvine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-23.

Sponsored by University of California, Irvine · Observational

Why this study was terminated
Study Investigator has suddenly died, study has no results.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Burns

Keywords

  • Burn injury
  • Skin graft
  • Donor site dressing
  • Outcomes
  • Infection rate
  • Healing time
  • Cosmetic Result
  • Pain
  • Burn injured patients requiring skin grafting
03

In context

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

  • Individuals under the age of 18.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)

Groups and cohorts

  • Single arm study

    Burn patients or patients with skin loss requiring split-thickness skin graft

    Other: Aquacel Ag · Other: Glucan II

Interventions

  • OtherAquacel Ag

    Aquacel Ag will be applied to one donor site.

  • OtherGlucan II

    Glucan II to be applied to a donor site on same patient for comparison

06

What researchers measure

Primary outcomes

  1. Healing time

    Time frame: 7 - 14 days

Secondary outcomes

  1. Infection rate

    Time frame: 1-21 days

  2. Cosmetic outcome

    Time frame: 6 months

  3. Pain rating

    Time frame: 6 months

07

Study locations

1 site
  • University of California Irvine Medical Center
    Orange, California 92868, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00581217
Lead sponsor
University of California, Irvine
Responsible party
Sponsor
First posted
Dec 27, 2007
Start date
Dec 2007
Primary completion
Mar 2010
Completion
Sep 2010
Last update
Jul 23, 2018

Study contacts

Marianne E Cinat, MD
principal investigator · University of California, Irvine
Suzanne Bailey, PT
principal investigator · University of California, Irvine
Melissa Carmean, PT, CWS, BS
principal investigator · University of California, Irvine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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