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Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds

This study is not yet open for participant recruitment.
Verified by The University of Texas Health Science Center at San Antonio, May 2008

Sponsored by: The University of Texas Health Science Center at San Antonio
Information provided by: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00686296
  Purpose

To evaluate wound healing with the use of Taliderm™ dressing and compare it to wet to dry dressing in the treatment of open wounds after incision and drainage.


Condition Intervention
Wounds
Other: Taliderm™
Other: standard wet to dry dressing with gauze

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:   Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • The primary endpoint of this study will be rate of wound healing (judged as per cent complete wound closure) at the two (2) and three (3) week follow-up visits. [ Time Frame: two and three weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • occurence of wound infection [ Time Frame: two and three weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   120
Study Start Date:   June 2008
Estimated Primary Completion Date:   June 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Group II: Active Comparator
Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing. Gauze dressing changes will continue per standard of care until the scheduled follow-up visits (first or second visit). At the scheduled follow-up visits, the subject will have a Taliderm™ dressing applied and left in place until the next scheduled dressing change (up to eight hours), then will continue standard of care wet to dry gauze dressing changes until next scheduled follow-up visit.
Other: Taliderm™
Taliderm™ dressing application up to three applications
III: No Intervention
standard wet to dry dressing with gauze
Other: standard wet to dry dressing with gauze
wet to dry dressing standard of care
group I: Active Comparator
Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing
Other: Taliderm™
taliderm™ dressing application once

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Inpatients with soft tissue abscess that will result in an open surgical wounds greater than or equal to 4 cms in any dimension
  • Wound will require serial dressing changes
  • Greater than or equal to 18 years of age
  • Ability to obtain informed consent

Exclusion Criteria:

  • Inability to obtain informed consent
  • Pregnancy
  • Prisoner
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686296

Contacts
Contact: Rachelle Jonas, RN, BSN     210-567-3623     babbittr@uthscsa.edu    
Contact: Janet McCarthy, RN, CCRC     210-567-3623     mccarthyj@uthscsa.edu    

Locations
United States, Texas
University Hospital     Not yet recruiting
      San Antonio, Texas, United States, 78229
      Contact: John Myers, MD     210-567-3623        
      Principal Investigator: John G Myers, MD            
      Sub-Investigator: Stephen M. Cohn, MD            

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio

Investigators
Principal Investigator:     John G Myers, MD     The University of Texas Health Science Center at San Antonio    
  More Information

Responsible Party:   University of Texas Health Science Center at San Antonio ( John G. Myers, M.D. )
Study ID Numbers:   HSC-2007-0709-H
First Received:   May 26, 2008
Last Updated:   May 28, 2008
ClinicalTrials.gov Identifier:   NCT00686296
Health Authority:   United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
soft tissue abscess requiring incision and drainage  

Study placed in the following topic categories:
Abscess

ClinicalTrials.gov processed this record on September 05, 2008




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