Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233812
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-09
Brief Title:
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement A Split-scar Randomized Non-inferiority Comparison
Status:
RECRUITING
Status Verified Date:
2024-01
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 study hypothesis is that the use of running epidermal sutures in full-thickness skin graft FTSG placement for patients undergoing dermatologic surgery Mohs micrographic surgery or excision is non-inferior to the use of simple interrupted sutures with respect to cosmetic outcome This will be a split-scar within-person study in which half of each participants scar will receive the study intervention running epidermal sutures with the other half receiving the control intervention simple interrupted sutures The primary outcome total observer score of the Patient and Observer Scar Assessment Scale POSAS 20 will be assessed by two blinded observers at a 3-month follow-up visit and compared between scar halves
Detailed Description:
A FTSG is used in lieu of linear repair or local tissue skin flap rearrangement when surrounding skin tissue laxity is unavailable or the patient prefers a graft instead Typically the skin for a FTSG is harvested from a local or distant donor site depending on skin tissue match and tissue availability and sutured into place The site where the FTSG was taken is primarily repaired or allowed to heal via second intent This study is important because it provides a comparison of cosmetic outcome between interrupted versus running cutaneous sutures The information provided would help determine if a more efficient suturing technique is non-inferior to a less efficient one thus saving time for the patient and provider There is no current standard of practice with dermatologic surgeons using both interrupted and running sutures as there is a paucity of literature on this topic as related to full thickness grafts after dermatologic surgery Running epidermal sutures are more time efficient and thus decrease patient intra-operative time save on suture material increase surgeon productivity and may improve the overall patient operative experience There have been multiple other split scar studies and studies related to the cosmetic outcomes of various suturing practices However there have been none that have looked at simple versus running epidermal stitching of FTSG placement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None