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

Not Applicable

Completed

• Conditions: Wounds
• Interventions: Other: standard wet to dry dressing with gauze; Other: Taliderm™

• Registration Number: NCT00686296
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-26
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Study Start: 2008-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
III	standard wet to dry dressing with gauze	standard wet to dry dressing with gauze
Group II	Taliderm™	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.
group I	Taliderm™	Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
occurence of wound infection	two and three weeks

Trial Locations

Locations (1)

University Hospital; 🇺🇸 San Antonio, Texas, United States