Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00964470

Acronym

AWBAT-D

Enrollment

Registered

2009-08-25

Start date

2009-08-31

Completion date

Unknown

Last updated

2010-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Donor Site Burns

Keywords

Burn, donor site, skin graft, dressing, AWBAT™-D, XEROFORM™, GLUCAN II™

Brief summary

The purpose of this study is to compare the rate of healing and the non-adherence of three types of dressings. The study will also compare rate of infection, scarring and perception of pain associated with treatment.

Detailed description

The purpose of this study is to evaluate AWBAT™-D compared to Xeroform™ or Glucan II™ for the treatment of donor sites in burn surgery. Primary Study Goals: * To compare the rate of healing of donor sites. * To compare patient reported perception of pain * To compare the potential clinical complication rates of: * non-adherence, * seroma * hematoma * infection Secondary Study Goal: • To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.

Interventions

DEVICEAWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings

Dressing, donor site dressings

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Burn wounds measuring 1% - 30% TBSA requiring skin grafting * Anterior bilateral donor sites of approximately the same size taken from the thighs or abdomen

Exclusion criteria

* Ventilator dependence * Pregnancy /Lactation * Mechanism of injury was electrical, chemical or frostbite * Co-morbidity which may compromise healing * Known allergy to porcine or porcine products

Design outcomes

Primary

Measure	Time frame
• To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection	2 year follow-up

Secondary

Measure	Time frame
• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.	2 year follow-up

Countries

United States

Contacts

Primary ContactSteven Moss

smoss@aubreyinc.com760-602-8300

Backup ContactTara Cordova

tcordova@aubreyinc.com760-602-8300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026