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

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.

Study Overview

• Status: Completed
• Conditions: Wounds
• Intervention / Treatment: Other: Taliderm™; Other: Taliderm™; Other: standard wet to dry dressing with gauze

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 once; Other: Taliderm™; Taliderm™ dressing application up to three applications
Other: 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; Other: Taliderm™; Taliderm™ dressing application up to three applications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	two and three weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
occurence of wound infection	two and three weeks

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: May 26, 2008
• First Submitted That Met QC Criteria: May 28, 2008
• First Posted (Estimate): May 29, 2008

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: soft tissue abscess requiring incision and drainage
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: HSC-2007-0709-H