Evaluation of ACell Hydrated Wound Dressing for Autogenou... | NCT00352729

Studies
Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

NCT00352729

Sponsor

United States Army Institute of Surgical Research

Status

Withdrawn

Last Update Posted

Jul 21, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Burns

Interventions

ACell dressing

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI decided to use another product

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Jul 13, 2006

First Submission Date that Met QC Criteria

Jul 13, 2006

First Posted Date

Jul 17, 2006Estimated

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

Jul 20, 2015

Last Update Posted Date

Jul 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to see if treating a donor site wound with the ACell dressing is as good as or better than the dressings we currently treat harvested donor sites with. This will be tested on consenting burn patients who require excision and grafting surgery for their burn wounds.

Hypothesis: The mean healing time for wounds treated with the ACell dressing will be less than the mean healing time for wounds treated with the Standard of Care dressing.

Detailed Description

This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of the ACell Dressing for use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing, which is currently Xeroform.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
A	Active Comparator		Device: ACell dressing

Name	Type	Description	Arm Group Labels	Other Names
ACell dressing	Device	dressing	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The specific aim of this study is to determine if the ACell dressing is superior to the ISR Burn Center's current standard of care dressing with respect to speed of healing, patient comfort or wound cosmesis.		14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

less than 30% total body surface area burn
burn wounds do not involve the donor site harvesting areas
requires excision and grafting of sufficient extent to justify two donor site of roughly equal size on non-dependent body surfaces.
The scheduled excision and grafting procedure is the first such operation for the subject
subject agrees to participate in follow-up evaluations

Exclusion Criteria:

Critical illnesses such as those requiring ventilator support, systemic infection, or hemodynamic instability
Major acute or chronic medical illness that could affect wound healing
Cellulitis or other infection of the potential donor sites
Donor site has been previously harvested for grafting
Subjects who are pregnant
Religious objections or allergy to porcine products

Accepts Healthy Volunteers

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
Michael Albrecht, MD	U.S. Army Institute of Surgical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
U.S. Army Insitute of Surgical Research		Fort Sam Houston	Texas	78234	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15157928	Background	Badylak SF. Xenogeneic extracellular matrix as a scaffold for tissue reconstruction. Transpl Immunol. 2004 Apr;12(3-4):367-77. doi: 10.1016/j.trim.2003.12.016.