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TerminatedNCT00519493Updated Mar 8, 2019

A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

An interventional study of Suture and Clozex in Keloid, sponsored by University of Miami. Terminated at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-03-08.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

Why this study was terminated
Issues with application of Clozex intervention
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

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.

Read the 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
02

Conditions studied

  • Keloid

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Keywords

  • Clozex
  • Sutures
03

In context

Keloid

123 studies on the registry are indexed under Keloid; 23 are open to participants now.

This study's enrollment of 3 is below the median of 30 across 97 interventional studies indexed under Keloid.

Browse Keloid studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
3 participants (actual)

Study arms

  • Active comparator
    Suture

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

    Procedure: Suture

  • Active comparator
    Clozex

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

    Device: Clozex

Interventions

  • ProcedureSuture

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

  • DeviceClozex

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

06

What researchers measure

Primary outcomes

  1. Global appearance at Keloid site.

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

Secondary outcomes

  1. Global appearance at Keloid site.

    Time frame: 3 months (+/-3 weeks)

  2. Global appearance at Keloid site.

    Time frame: 6 months (+/-4 weeks)

07

Study locations

1 site
  • Skin Research Group Office
    Miami, Florida 33136, United States
08

References and documents

Publications

  • 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. PubMed 9810991 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00519493
Lead sponsor
University of Miami
Responsible party
Robert S. Kirsner (Professor, University of Miami) — Principal investigator
First posted
Aug 22, 2007
Start date
Aug 2007
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Mar 8, 2019

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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