Split-Thickness Skin Graft Donor Site Wound Healing Study | NCT00392301

Studies
Split-Thickness Skin Graft Donor Site Wound Healing Study

NCT00392301

Sponsor

University of Mississippi Medical Center

Status

Withdrawn

Last Update Posted

Feb 22, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Split-thickness Skin Graft Donor Sites

Interventions

Not provided

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not funded - and PI left for another position in 2012

Expanded Access Info

Start Date

Oct 2009Estimated

Primary Completion Date

Jul 1, 2012Actual

Completion Date

Jul 1, 2012Actual

First Submitted Date

Oct 23, 2006

First Submission Date that Met QC Criteria

Oct 24, 2006

First Posted Date

Oct 25, 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

Feb 20, 2018

Last Update Posted Date

Feb 22, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Annette Wysocki, PhD, RN, Associate Dean for Research and Professor, University of Massachusetts, AmherstPrincipal Investigator

Lead Sponsor

University of Mississippi Medical CenterOTHER

Collaborators

Not provided

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 research study is to discover whether instruments widely used in skin research can be used to measure wound healing in split thickness skin graft donor sites and whether these instruments can detect differences in healing when two different dressing products are used.

Detailed Description

Currently there is no standard treatment to promote wound healing for split thickness skin graft donor sites and healing is determined based on clinical observation of the graft donor site and clinical judgement. Here we propose to use two instruments commonly used in skin research to measure wound healing. This study will validate the use of these two instruments, one that measures transepidermal water loss and the other that measures skin pigmentation to determine healing. To further validate the use of these instruments we will determine if these instruments can detect differences between two different wound dressing products that have been previously reported to heal skin graft donor sites at different rates.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants 18 years of age and over who have a split-thickness skin graft donor site.

Exclusion Criteria:

Individuals under 18 years of age.
Individuals who do not have a split thickness skin graft donor site.

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

Subjects with split thickness skin graft donor sites

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annette B. Wysocki, PhD, RN	University of Mississippi Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Mississippi Medical Center		Jackson	Mississippi	39216	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11324883	Background	Disa JJ, Alizadeh K, Smith JW, Hu Q, Cordeiro PG. Evaluation of a combined calcium sodium alginate and bio-occlusive membrane dressing in the management of split-thickness skin graft donor sites. Ann Plast Surg. 2001 Apr;46(4):405-8. doi: 10.1097/00000637-200104000-00009.
1907769	Background	Feldman DL, Rogers A, Karpinski RH. A prospective trial comparing Biobrane, Duoderm and xeroform for skin graft donor sites. Surg Gynecol Obstet. 1991 Jul;173(1):1-5.