Pinch Grafting Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects on the Scalp

NCT ID: NCT06287866

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2026-12-01

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.

Conditions

Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Second Intention Wound Healing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pinch Grafting

Group Type: EXPERIMENTAL

Pinch Graft

Intervention Type: PROCEDURE

In the pinch graft technique, the investigators will numb and then shave off a thin piece of skin and place it in the wound bed.

Interventions

Pinch Graft

In the pinch graft technique, the investigators will numb and then shave off a thin piece of skin and place it in the wound bed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Able to give informed consent themselves
• Patient scheduled for cutaneous surgical procedure on the scalp with predicted second intention closure
• Willing to return for follow up visit
• Active user of MyChart
• Willing to send weekly messages until wound is healed

Exclusion Criteria

• Incarceration
• Under 18 years of age
• Pregnant women
• Unable to understand written and oral English
• Scalp wounds with planned primary repair reconstruction
• Surgical defects with bone exposure
• No MyChart access or use

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Eisen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis - Dermatology

Locations

University of California, Davis - Dermatology Department

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

John Robb, BS, BA

Role: CONTACT

jmrobb@ucdavis.edu

9165512636

Keemberly Kim, MD

Role: CONTACT

keekim@ucdavis.edu

9168161525

Facility Contacts

John Robb, BS

Role: primary

jmrobb@ucdavis.edu

916-551-2636

Daniel Eisen, MD

Role: backup

dbeisen@ucdavis.edu

916-551-2611

References

Burns DA, Sarkany I. Management of stasis ulcers by pinch graft. Br J Dermatol. 1976 Jul;95 Suppl 14:82. doi: 10.1111/j.1365-2133.1976.tb07931.x. No abstract available.

Reference Type: BACKGROUND

PMID: 776204 (View on PubMed)

Millard LG, Roberts MM, Gatecliffe M. Chronic leg ulcers treated by the pinch graft method. Br J Dermatol. 1977 Sep;97(3):289-95. doi: 10.1111/j.1365-2133.1977.tb15185.x.

Reference Type: BACKGROUND

PMID: 336073 (View on PubMed)

Ramanujam CL, Zgonis T. Pinch graft harvesting technique for surgical closure of the diabetic foot. Clin Podiatr Med Surg. 2012 Oct;29(4):585-8. doi: 10.1016/j.cpm.2012.07.004. Epub 2012 Aug 30.

Reference Type: BACKGROUND

PMID: 23044064 (View on PubMed)

Claude O, Binder JP, Bustamante K, Blanchet-Bardon C, Andrivon F, Revol M, Servant JM. [Role of cutaneous pinch grafts in the healing of patients with dystrophic epidermolysis bullosa wounds: report of four cases]. Ann Chir Plast Esthet. 2005 Jun;50(3):189-96. doi: 10.1016/j.anplas.2004.11.010. Epub 2004 Dec 18. French.

Reference Type: BACKGROUND

PMID: 15963838 (View on PubMed)

Willenbrink TJ, Brodland DG. Pinch Grafts Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects Below the Knee: A Prospective Randomized Trial. Dermatol Surg. 2024 Nov 1;50(11):1010-1016. doi: 10.1097/DSS.0000000000004272. Epub 2024 Aug 1.

Reference Type: BACKGROUND

PMID: 39088685 (View on PubMed)

Joo J, Custis T, Armstrong AW, King TH, Omlin K, Kappel ST, Eisen DB. Purse-string suture vs second intention healing: results of a randomized, blind clinical trial. JAMA Dermatol. 2015 Mar;151(3):265-70. doi: 10.1001/jamadermatol.2014.2313.

Reference Type: BACKGROUND

PMID: 25372450 (View on PubMed)

Other Identifiers

2099470

Identifier Type: -

Identifier Source: org_study_id