Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-03 @ 5:24 PM
Study NCT ID:
NCT06287866
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2024-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pinch Grafting Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects on the Scalp
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
Pinch Grafting Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects on the Scalp
Status:
RECRUITING
Status Verified Date:
2025-09
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:
Oftentimes, following surgery on the scalp, wounds are left to heal by themselves. This is called "second intention." Open wounds left to heal on the scalp often take 8 weeks or more to completely heal. The investigators are investigating how second intention closure compares to another established reconstruction technique, called "pinch graft." In the pinch graft technique, a dermatological surgeon numbs and then shaves off a thin piece of skin (usually from the groin area) and places it in the wound bed it (also known as "grafting"), to encourage growth of new healthy skin. This study will compare time-to-healing in the second intention method versus the pinch graft method.
Detailed Description:
Pinch graft methodology was first developed in 1976 as a treatment to accelerate healing of lower leg ulcerations, particularly venous or gravitational ulcerations (1, 2). It was later adapted as a tool to hasten healing in surgical wounds, such as surgical closure of diabetic foot wounds (3). It has also been used in the healing of patients with wounds related to dystrophic epidermolysis bullosa (4). More recently, pinch grafts have been investigated as a reconstruction option for Mohs micrographic surgery defects (5). In this study, patients with below the knee Mohs surgical defects were randomized to receive either PG reconstruction or SIH reconstruction. Patients with PG reconstruction healed 20 days sooner (i.e., faster time to reepithelialization) than those who underwent SIH. Complication rates, including infection and reported pain, were also lower in the PG cohort compared to the SIH cohort. SIH is often recommended as a reconstruction technique for surgical wounds without adjacent skin laxity to support primary closure, such as the anterior lower extremity and scalp. There is no study to date examining the use of pinch grafts in scalp wounds. In our study, the investigators explore whether PG is a viable and useful reconstruction method for wounds on the scalp that otherwise would be left to close via SIH. Specifically, in our study, the investigators examine the comparative time to healing and complication rates between PG and SIH in Mohs surgical defects of the scalp.
Study Oversight
Has Oversight DMC:
False
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?: