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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

August 21, 2007
October 18, 2010
August 2007
March 2009   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00519493 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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) ]
  • 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) ]
Not Provided
Not Provided
 
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

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Keloid
  • 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.
  • Active Comparator: Suture
    A keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.
    Intervention: Procedure: Suture
  • Active Comparator: Clozex
    One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex.
    Intervention: Device: Clozex
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00519493
20061027
No
Brian Berman, M.D., Ph.D., University of Miami Miller School of Medicine
University of Miami
Not Provided
Principal Investigator: Brian Berman, M.D., Ph.D. University of Miami Department of Dermatology and Cutaneous Surgery
University of Miami
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP