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

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