A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Miami.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00519493
First received: August 21, 2007
Last updated: October 18, 2010
Last verified: June 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Two Part Study: An Investigator-initiated, Single-center, Single-blinded, Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The investigator and subject will assess the keloid sites for Global appearance, Color, Matte/Shiny, Contour, Distortion, Texture, Oozing, Redness, Warmth, Firmness. [ Time Frame: 3 months (+/-3 weeks) ] [ Designated as safety issue: Yes ]
  • The investigator and subject will assess the keloid sites for Global appearance, Color, Matte/Shiny, Contour, Distortion, Texture, Oozing, Redness, Warmth, Firmness. [ Time Frame: 6 months (+/-4 weeks) ] [ Designated as safety issue: Yes ]

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
Active Comparator: Suture
A keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.
Procedure: Suture
One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.
Active Comparator: Clozex
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.

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
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or females, in good health, and at least 12 years of age.
  • Individuals with 2 or more keloids on the trunk, arm, leg, and neck between 0.5 and 2 cm in length.
  • Individuals who are willing and able to participate in the requirements of the study, including signing the informed consent.
  • In the opinion of the investigator, the 2 keloids can be excised in a similar manner and closed properly with the two techniques and will benefit from the procedure.
  • In the opinion of the investigator, the keloid could benefit from surgical procedure.

Exclusion Criteria:

  • Individuals with keloids that do not fit into the criteria.
  • Individuals who are planning pregnancy, pregnant, or breast feeding.
  • Individuals with a history of medical or dermatologic conditions which, in the opinion of the investigator, would put the subject at heightened risk or would limit complicate the study evaluations required by the protocol.
  • Individuals who present with excessive body hair in the designed keloid area.
  • Individuals with uncontrolled diabetes.
  • Individuals with autoimmune disorders (HIV/AIDs, SLE).
  • Subjects who have received keloid treatment within one month of the first day of the study.
  • Individuals who plan to receive keloid treatment(s) during the study.
  • Individuals who are currently taking prescription or over the counter medication or interventions on a regular basis that as part of their mechanism of action, have the potential to mask an inflammatory reaction. Examples of such medications include, but are not limited to, corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), antihistamines, aspirin (81mg or less daily dosage permissible), or other medications that in the opinion of the investigator or designee may expose the subject to heightened risk or complicate the study assessments.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519493

Locations
United States, Florida
Skin Research Group Office
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Brian Berman, M.D., Ph.D. University of Miami Department of Dermatology and Cutaneous Surgery
  More Information

Additional Information:
Publications:
Responsible Party: Brian Berman, M.D., Ph.D., University of Miami Miller School of Medicine
ClinicalTrials.gov Identifier: NCT00519493     History of Changes
Other Study ID Numbers: 20061027
Study First Received: August 21, 2007
Last Updated: October 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Clozex
Sutures

Additional relevant MeSH terms:
Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014