NCT00581217

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

2.2 years

First QC Date

December 21, 2007

Last Update Submit

July 19, 2018

Conditions

Burns

Keywords

Burn injurySkin graftDonor site dressingOutcomesInfection rateHealing timeCosmetic ResultPainBurn injured patients requiring skin grafting

Outcome Measures

Primary Outcomes (1)

  • Healing time

    7 - 14 days

Secondary Outcomes (3)

  • Infection rate

    1-21 days

  • Cosmetic outcome

    6 months

  • Pain rating

    6 months

Study Arms (1)

Single arm study

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

Other: Aquacel AgOther: Glucan II

Interventions

Aquacel AgOTHER

Aquacel Ag will be applied to one donor site.

Single arm study
Glucan IIOTHER

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

Single arm study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Individuals under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

BurnsPain

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 27, 2007

Study Start

December 1, 2007

Primary Completion

March 1, 2010

Study Completion

September 1, 2010

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations

US(1)