Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 4:34 PM
Study NCT ID:
NCT01298167
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2011-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Fast Absorbing Gut Suture Versus Cyanoacrylate Tissue Adhesive in the Epidermal Closure of Linear Repairs Following Mohs Micrographic Surgery
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to look at which nonpermanent superficial closure method, cyanoacrylate tissue glue or fast absorbing gut suture, leads to a better cosmetic and functional outcome in repairs of facial wounds after Mohs surgery.
Detailed Description:
Cyanoacrylate is a rapidly polymerizing topical adhesive commonly used as an alternative to traditional sutures. Both cyanoacrylate and fast absorbing gut suture eliminate the need for suture removal which can represent a significant savings in patient and staff time as well as related healthcare resources. Both cyanoacrylate and fast absorbing gut suture are currently routinely used for epidermal closure at Yale following Mohs micrographic surgery. Physician preference currently dictates which epidermal closure method is chosen for a given surgery.
Cyanoacrylate has been reported to decrease trauma to the epidermal edges, minimize suture tract marks in surgical scars, and decrease the risk of inflammatory reaction to suture material. Cyanoacrylate, however, does not allow for wound eversion.
Wound eversion minimizes the risk of a depressed scar from tissue contraction during healing. As with all sutures, fast absorbing gut suture allows for wound eversion which is reported to maximize the likelihood of a good epidermal approximation. On the other hand, fast absorbing gut suture degrades by proteolysis which can result in an inflammatory reaction. Any inflammatory reaction on the skin while healing can affect the final cosmetic outcome (ie. post-inflammatory hyperpigmentation).
A recent article (Tierney 2009), reported that tissue adhesive may not be as effective in achieving optimal cosmesis as fast absorbing gut for defects on the trunk and extremities. However, we would like to study these two methods for the repair of facial wounds, which are in low tension areas as compared to trunk and extremities. Therefore, it is unknown exactly which of these two method is better than the other in epidermal closure of facial wounds follow Mohs micrographic surgery.
Cyanoacrylate has been reported to decrease trauma to the epidermal edges, minimize suture tract marks in surgical scars, and decrease the risk of inflammatory reaction to suture material. Cyanoacrylate, however, does not allow for wound eversion.
Wound eversion minimizes the risk of a depressed scar from tissue contraction during healing. As with all sutures, fast absorbing gut suture allows for wound eversion which is reported to maximize the likelihood of a good epidermal approximation. On the other hand, fast absorbing gut suture degrades by proteolysis which can result in an inflammatory reaction. Any inflammatory reaction on the skin while healing can affect the final cosmetic outcome (ie. post-inflammatory hyperpigmentation).
A recent article (Tierney 2009), reported that tissue adhesive may not be as effective in achieving optimal cosmesis as fast absorbing gut for defects on the trunk and extremities. However, we would like to study these two methods for the repair of facial wounds, which are in low tension areas as compared to trunk and extremities. Therefore, it is unknown exactly which of these two method is better than the other in epidermal closure of facial wounds follow Mohs micrographic surgery.
Study Oversight
Has Oversight DMC:
True
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?: