Study Evaluating AWBAT-D Versus the Standard of Care of Split-thickness Skin Graft Donor Sites

Randomized, Prospective, Pilot Study Evaluating a Temporary Skin Substitute (AWBAT-D) Versus the Standard of Care in the Postoperative Treatment of Split-thickness Skin Graft Donor Sites

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01252836

Enrollment

Registered

2010-12-03

Start date

2010-09-30

Completion date

2015-04-30

Last updated

2016-12-15

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

Conditions

Healing of Donor Site, Pain Level

Brief summary

Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.

Detailed description

The study is designed as a randomized-controlled trial to examine split thickness skin graft donor wound site healing using AWBAT-D compared to current standard of care: Tegaderm. This will involve randomizing subjects to treatment with the AWBAT-D dressing or Tegaderm and monitoring outcomes. The AWBAT-D device has collagen and we hypothesize that the wounds treated with it will heal faster and with a decreased pain level. The purpose of this study is to evaluate if there are differences in outcomes between AWBAT-D and Tegaderm in healing split thickness skin graft donor sites.

Interventions

DEVICEAWBAT-D

Application of AWBAT-D bioengineered device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Subject is 18 years of age or older 2. Subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um. 3. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.

Exclusion criteria

1. Subjects \< 18 years of age 2. Subjects with an allergy to porcine products. 3. Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm2. 4. Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um. 5. Subjects undergoing repeat skin graft harvesting at the same donor site. 6. Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. 7. Subjects participating in any other trials involving the split-thickness skin graft donor site.

Design outcomes

Primary

Measure	Time frame	Description
Time for donor site to heal with AWBAT-D	6 weeks	As compared to current standard of care, Tegaderm.

Secondary

Measure	Time frame	Description
Pain at donor site	6 weeks	Pain at donor site is less than that of standard of care treatment, Tegaderm.

Countries

United States

Outcome results

None listed

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