A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids
| Status: | Terminated |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 3/10/2019 |
| Start Date: | August 2007 |
| End Date: | December 2007 |
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.
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
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
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.
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