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| Sponsored by: |
University of Miami |
| Information provided by: | University of Miami |
| ClinicalTrials.gov Identifier: | NCT00519493 |
Purpose
This investigator initiated study, single-blinded, parallel, randomized study will be conducted in subjects with 2 or more keloids similar in size and duration on a similar area of the body. The response of the closure techniques will be evaluated by clinical and instrumental assessments. Each qualified subject will be assessed and the keloids will be randomly assigned to the Clozex or suture closure. One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex. A second keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures. The inflammation index and the keloid recurrence rate at each surgical wound closure site will be compared.
| Condition | Intervention | Phase |
|
Keloid |
Procedure: Suture Device: Clozex |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study |
| Official Title: | A Two Part Study: An Investigator-Initiated, Single-Center, Single-Blinded, Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids |
| Estimated Enrollment: | 15 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Suture: Active Comparator
A keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.
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Procedure: Suture
One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.
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Clozex: Active Comparator
One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex.
|
Device: Clozex
One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex.
|
This study will be undertaken to compare the efficacy of two closure techniques for excised keloids. (1) Clozex, a non-latex, hypoallergenic adhesive polymeric interlaced film designed to adhere to proximal wound edges for 7-10 days, will be used after the punch biopsy or excision of a keloid and (2) sutures to close a similar second keloid after the punch biopsy or excision of a keloid.
On day 12, the investigator and subject will assess the keloid site(s) with the use of a visual analog scale.
There is an optional follow-up at 3 months and 6 months to assess the recurrence of the keloid and the effectiveness of the treatments with a visual analog scale.
The subject will assess the keloid site(s) with the use of the following visual analog scale:
The investigator will assess the keloid site(s) with the use of this visual analog scale:
Eligibility
| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |||||
| Skin Research Group Office | |||||
| Miami, Florida, United States, 33136 | |||||
| University of Miami |
| Principal Investigator: | Brian Berman, M.D., Ph.D. | University of Miami Department of Dermatology and Cutaneous Surgery |
More Information
Homepage of Skin Research Group 
  |
| Responsible Party: | University of Miami Miller School of Medicine ( Brian Berman, M.D., Ph.D. ) |
| Study ID Numbers: | 20061027 |
| First Received: | August 21, 2007 |
| Last Updated: | June 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00519493 |
| Health Authority: | United States: Institutional Review Board |
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