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

September 12, 2025 updated by: University of California, Davis
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • Recruiting
        • University of California, Davis - Dermatology Department
        • Principal Investigator:
          • Daniel Eisen, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Keemberly Kim, MD
        • Sub-Investigator:
          • Ilana Breen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Second Intention Wound Healing
Experimental: Pinch Grafting
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to re-epithelialization
Time Frame: 1-8 weeks
Participants will submit weekly photos to blinded reviewers to assess for re-epithelization.
1-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
Time Frame: 3 months
The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability, and surface area). All items are scored on a scale ranging from 1 ("like normal skin") to 10 ("worst scar imaginable"). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.
3 months
Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
Time Frame: 3 months
This is the patient portion of the POSAS assessment, which will be independently recorded. The patient scale of the POSAS consists of six items (pain, itch, thickness, color, stiffness, and irregularity). All items are scored on a scale ranging from 1 ("as normal skin") to 10 ("yes, very different"). The sum of the six items results in a total score of the POSAS patient scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Daniel Eisen, MD, University of California, Davis - Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2099470

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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