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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00686296
First received: May 26, 2008
Last updated: March 7, 2012
Last verified: March 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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 ]

Enrollment: 56
Study Start Date: December 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group II
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
No Intervention: III
standard wet to dry dressing with gauze
Other: standard wet to dry dressing with gauze
wet to dry dressing standard of care
Active Comparator: group I
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
University Hospital
San Antonio, Texas, United States, 78229
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

No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00686296     History of Changes
Other Study ID Numbers: HSC-2007-0709-H
Study First Received: May 26, 2008
Last Updated: March 7, 2012
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

ClinicalTrials.gov processed this record on September 18, 2014