NCT00519493

A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

A Two Part Study: An Investigator-initiated, Single-center, Single-blinded, Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

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: 1. Cosmetic appearance 2. Pain 3. Tenderness 4. Itching 5. Oozing 6. Redness 7. Warmth The investigator will assess the keloid site(s) with the use of this visual analog scale: 1. Global appearance 2. Color 3. Matte/Shiny 4. Contour 5. Distortion 6. Texture 7. Oozing 8. Redness 9. Warmth 10. Firmness

Conditions

• Keloid

Interventions

Type	Name	Description
PROCEDURE	Suture	One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.
DEVICE	Clozex	One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex.

Timeline

• Start date: 2007-08-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-08-22
• Last updated: 2019-03-08

Locations

1 site across 1 country: United States