Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519493
Status:
TERMINATED
Last Update Posted:
2019-03-08
First Post:
2007-08-21
Brief Title:
A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
A Two Part Study An Investigator-initiated Single-center Single-blinded Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Issues with application of Clozex intervention
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sites 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 sites 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 sites with the use of this visual analog scale
1 Global appearance
2 Color
3 MatteShiny
4 Contour
5 Distortion
6 Texture
7 Oozing
8 Redness
9 Warmth
10 Firmness
On day 12 the investigator and subject will assess the keloid sites 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 sites 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 sites with the use of this visual analog scale
1 Global appearance
2 Color
3 MatteShiny
4 Contour
5 Distortion
6 Texture
7 Oozing
8 Redness
9 Warmth
10 Firmness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None