Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00519493
Study type Interventional
Source University of Miami
Contact
Status Terminated
Phase N/A
Start date August 2007
Completion date December 2007

See also
  Status Clinical Trial Phase
Recruiting NCT02923596 - Retrospective Study of Keloid Disorder N/A
Completed NCT02922972 - Treatment of Keloid Scar by Autologous Platelet Rich Plasma Obtained With RgenKit-BCT N/A
Terminated NCT01478243 - Study of Psycho-Social Impact of Keloid N/A
Recruiting NCT01423383 - Epidemiology Study of Keloid N/A
Completed NCT03228693 - Gene Expression and Biomarker Profiling of Keloid Skin N/A
Not yet recruiting NCT04326959 - Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Phase 1/Phase 2
Recruiting NCT03312166 - Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS] N/A
Recruiting NCT02823236 - Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars Phase 3
Recruiting NCT04597060 - The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids N/A
Completed NCT05887804 - Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial Phase 4
Completed NCT05939817 - The Effect of Intralesian Injection of Umbilical Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide on Type 1:3 Collagen Ratio and Interleukin-10 Levels in Keloid: A Randomised Controlled Trial Phase 4
Completed NCT03630198 - Pain Outcomes Following Intralesional Corticosteroid Injections Phase 4
Completed NCT04169438 - Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions N/A
Recruiting NCT01423981 - Web Based Investigation of Natural History of Keloid Disorder, an Online Survey N/A
Completed NCT01446770 - Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181 Phase 2
Recruiting NCT06138964 - Comparing the Effect of siSPARC Microneedle Patch Versus siSPARC+siLR4A Microneedle Patch on Post-surgical Scars Phase 3
Enrolling by invitation NCT05461157 - Preoperative Silicone Ointment and Wound Healing N/A
Not yet recruiting NCT04593706 - Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) N/A
Active, not recruiting NCT04988022 - Dupilumab in the Treatment of Keloids Phase 4
Withdrawn NCT02546076 - Comparison of Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars Phase 2