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A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

NCT00519493 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-03-08

No results posted yet for this study

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.

Conditions

  • Keloid

Interventions

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.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Brian Berman, M.D., Ph.D. · University of Miami Department of Dermatology and Cutaneous Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00519493 on ClinicalTrials.gov