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| Tracking Information | |||||
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| First Received Date ICMJE | August 21, 2007 | ||||
| Last Updated Date | June 4, 2008 | ||||
| Start Date ICMJE | August 2007 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The investigator and subject will assess the keloid sites for Global appearance, Color, Matte/Shiny, Contour, Distortion, Texture, Oozing, Redness, Warmth, Firmness. [ Time Frame: 12 (+/-2) days after excision of keloid ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
The investigator and subject will assess the keloid sites for Global appearance, Color, Matte/Shiny, Contour, Distortion, Texture, Oozing, Redness, Warmth, Firmness. [ Time Frame: 12 (+/-2) days after excision of keloid ] | ||||
| Change History | Complete list of historical versions of study NCT00519493 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids | ||||
| Official Title ICMJE | A Two Part Study: An Investigator-Initiated, Single-Center, Single-Blinded, Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids | ||||
| Brief Summary | 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. |
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| Detailed Description | 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:
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Keloid | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | Beausang E, Floyd H, Dunn KW, Orton CI, Ferguson MW. A new quantitative scale for clinical scar assessment. Plast Reconstr Surg. 1998 Nov;102(6):1954-61. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 15 | ||||
| Estimated Completion Date | March 2009 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00519493 | ||||
| Responsible Party | Brian Berman, M.D., Ph.D., University of Miami Miller School of Medicine | ||||
| Study ID Numbers ICMJE | 20061027 | ||||
| Study Sponsor ICMJE | University of Miami | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Miami | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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