A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

NCT00519493 | Terminated

• 1 other identifier: 20061027
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Clozex; Sutures

Outcome Measures

Primary Outcomes (1)

• Global appearance at Keloid site.

  12 (+/-2) days after excision of keloid

Secondary Outcomes (2)

• Global appearance at Keloid site.

  3 months (+/-3 weeks)

• Global appearance at Keloid site.

  6 months (+/-4 weeks)

Study Arms (2)

Suture

ACTIVE COMPARATOR

A keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.

Procedure: Suture

Clozex

ACTIVE COMPARATOR

One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex.

Device: Clozex

Interventions

Suture PROCEDURE

One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.

Suture

Clozex DEVICE

One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex.

Clozex

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Skin Research Group Office

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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. doi: 10.1097/00006534-199811000-00022.

  PMID: 9810991 BACKGROUND

Related Links

• Homepage of Skin Research Group

MeSH Terms

Conditions

Keloid

Interventions

Sutures

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Brian Berman, M.D., Ph.D.

  University of Miami Department of Dermatology and Cutaneous Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 22, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

US (1)