Back to resultsPilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds
Primary Purpose
Wounds
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Taliderm™
Taliderm™
standard wet to dry dressing with gauze
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring soft tissue abscess requiring incision and drainage
Eligibility 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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Other
Active Comparator
Arm Label
Group II
III
group I
Arm Description
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.
standard wet to dry dressing with gauze
Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing
Outcomes
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.
Secondary Outcome Measures
occurence of wound infection
Full Information
NCT ID
NCT00686296
First Posted
May 26, 2008
Last Updated
March 16, 2015
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT00686296
Brief Title
Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds
Official Title
Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
soft tissue abscess requiring incision and drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
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.
Arm Title
III
Arm Type
Other
Arm Description
standard wet to dry dressing with gauze
Arm Title
group I
Arm Type
Active Comparator
Arm Description
Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing
Intervention Type
Other
Intervention Name(s)
Taliderm™
Intervention Description
taliderm™ dressing application once
Intervention Type
Other
Intervention Name(s)
Taliderm™
Intervention Description
Taliderm™ dressing application up to three applications
Intervention Type
Other
Intervention Name(s)
standard wet to dry dressing with gauze
Intervention Description
wet to dry dressing standard of care
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
occurence of wound infection
Time Frame
two and three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John G Myers, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds
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