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

NCT00686296 | Completed DMC

• 1 other identifier: HSC-2007-0709-H
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Keywords

soft tissue abscess requiring incision and drainage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• occurence of wound infection

  two and three weeks

Study Arms (3)

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™

III

OTHER

standard wet to dry dressing with gauze

Other: standard wet to dry dressing with gauze

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™

Interventions

Taliderm™ OTHER

taliderm™ dressing application once

group I

standard wet to dry dressing with gauze OTHER

wet to dry dressing standard of care

III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to obtain informed consent
• Pregnancy
• Prisoner

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• John G Myers, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2008
• First Posted: May 29, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

US (1)