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A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

Primary Purpose

Keloid

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Suture

Clozex

About this trial

This is an interventional treatment trial for Keloid focused on measuring Clozex, Sutures

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Skin Research Group Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Suture

Clozex

Arm Description

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

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

Outcomes

Primary Outcome Measures

Global appearance at Keloid site.

Secondary Outcome Measures

Global appearance at Keloid site.

Full Information

NCT ID

NCT00519493

First Posted

August 21, 2007

Last Updated

March 6, 2019

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT00519493

Brief Title

A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

Official Title

A Two Part Study: An Investigator-initiated, Single-center, Single-blinded, Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Terminated

Why Stopped

Issues with application of Clozex intervention

Study Start Date

August 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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: Cosmetic appearance Pain Tenderness Itching Oozing Redness Warmth The investigator will assess the keloid site(s) with the use of this visual analog scale: Global appearance Color Matte/Shiny Contour Distortion Texture Oozing Redness Warmth Firmness

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keloid

Keywords

Clozex, Sutures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Suture

Arm Type

Active Comparator

Arm Description

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

Arm Title

Clozex

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Suture

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Clozex

Intervention Description

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

Primary Outcome Measure Information:

Title

Global appearance at Keloid site.

Time Frame

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

Secondary Outcome Measure Information:

Title

Global appearance at Keloid site.

Time Frame

3 months (+/-3 weeks)

Title

Global appearance at Keloid site.

Time Frame

6 months (+/-4 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Berman, M.D., Ph.D.

Organizational Affiliation

University of Miami Department of Dermatology and Cutaneous Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Skin Research Group Office

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

9810991

Citation

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.

Results Reference

background

Links:

URL

http://www.skininvestigation.com

Description

Homepage of Skin Research Group

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A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids

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