Platelets in Acute Wounds: A Pilot Study (PAWS) | NCT00199992

Studies
Platelets in Acute Wounds: A Pilot Study (PAWS)

NCT00199992

Sponsor

Medtronic

Status

Completed

Last Update Posted

Sep 20, 2005Estimated

Enrollment

Phase

Not Applicable

Conditions

Wounds

Interventions

application of autologous platelet gel

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Aug 2005

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

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

Sep 12, 2005

Last Update Posted Date

Sep 20, 2005Estimated

Description Module

Brief Summary

Comparison of wound healing treatments; platelet gel vs. control

Detailed Description

Comparison of autologous platelet gel to a control treatment in acute wounds, specifically punch biopsy wounds. Eight patients included in this pilot/feasibility study. Wound healing evaluated over 6 months for wound closure and long term outcome.

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

Name	Type	Description	Arm Group Labels	Other Names
application of autologous platelet gel	Procedure

Measure	Description	Time Frame
Time to complete closure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy non-smokers, >18 years of age, BMI<30 -

Exclusion Criteria:

Smokers, obese, keloid formers, bleeding disorders, medications -

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
David HOM, M.D.	Hennepin County Medical Center/ University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DaVita Clinical Research		Minneapolis	Minnesota	55404	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17519207	Derived	Hom DB, Linzie BM, Huang TC. The healing effects of autologous platelet gel on acute human skin wounds. Arch Facial Plast Surg. 2007 May-Jun;9(3):174-83. doi: 10.1001/archfaci.9.3.174.

Measure	Description	Time Frame
pain
long-term scar appearance