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

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686296
• Other study ID #: HSC-2007-0709-H
• Status: Completed
• Phase: N/A
• First received: May 26, 2008
• Last updated: March 16, 2015
• Start date: December 2008
• Est. completion date: April 2011

Study information

• Verified date: March 2015
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

Other:
• Taliderm™
taliderm™ dressing application once
• Taliderm™
Taliderm™ dressing application up to three applications
• standard wet to dry dressing with gauze
wet to dry dressing standard of care

Locations

Country	Name	City	State
United States	University Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	occurence of wound infection		two and three weeks	No