NCT00974597

Brief Summary

The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of donor sites in burn surgery.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Last Updated

June 22, 2010

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

September 8, 2009

Last Update Submit

June 21, 2010

Conditions

Burn Surgery

Keywords

burndonor sitetreatment of burnsTreatment of Donor Sites

Outcome Measures

Primary Outcomes (1)

  • Compare rate of healing of donor sites

    6 month follow-up

Secondary Outcomes (3)

  • Compare complication rates

    6 month follow-up

  • Compare patient reported perception of pain

    6 month follow-up

  • Compare clinical outcome (scarring)

    6 month follow-up

Interventions

AWBAT™-D and Mepilex® Ag dressingsDEVICE

Comparison of AWBAT™-D and Mepilex® Ag dressings for treatment of donor sites in burn surgery.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Burn wounds requiring skin grafting
  • Matched donor sites available
  • % TBSA

You may not qualify if:

  • Severe inhalation injury
  • Pregnancy
  • Co-morbidity which may compromise healing
  • Known allergy to pork or pork products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doctors Hospital of Augusta

Augusta, Georgia, 30909, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 10, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Last Updated

June 22, 2010

Record last verified: 2009-12

Locations

US(1)