Study Evaluating AWBAT-D Versus the Standard of Care of S... | NCT01252836

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

NCT01252836

Sponsor

Georgetown University

Status

Withdrawn

Last Update Posted

Dec 15, 2016Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Healing of Donor Site
Pain Level

Interventions

AWBAT-D

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

P.I decided to prematurely end this study.

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Dec 1, 2010

First Submission Date that Met QC Criteria

Dec 2, 2010

First Posted Date

Dec 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2016

Last Update Posted Date

Dec 15, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	Treatment with Tegaderm	Device: AWBAT-D
AWBAT-D	Experimental	Application of AWBAT-D on donor site.	Device: AWBAT-D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AWBAT-D	Device	Application of AWBAT-D bioengineered device	AWBAT-D Control

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Subjects < 18 years of age
Subjects with an allergy to porcine products.
Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm2.
Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um.
Subjects undergoing repeat skin graft harvesting at the same donor site.
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.
Subjects participating in any other trials involving the split-thickness skin graft donor site.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher A Attinger, MD	Georgetown University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown University Hospital Center for Wound Healing		Washington D.C.	District of Columbia	20007	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Data was not collected for use in future research and will not be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided