NCT06287866

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Apr 2024Dec 2026

First Submitted

Initial submission to the registry

February 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 2, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

February 23, 2024

Last Update Submit

September 12, 2025

Conditions

Keywords

Pinch graft

Outcome Measures

Primary Outcomes (1)

  • Time to re-epithelialization

    Participants will submit weekly photos to blinded reviewers to assess for re-epithelization.

    1-8 weeks

Secondary Outcomes (2)

  • Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

    3 months

  • Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

    3 months

Study Arms (2)

Second Intention Wound Healing

NO INTERVENTION

Pinch Grafting

EXPERIMENTAL
Procedure: Pinch Graft

Interventions

Pinch GraftPROCEDURE

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.

Pinch Grafting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 776204BACKGROUND
  • 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.

    PMID: 336073BACKGROUND
  • 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.

    PMID: 23044064BACKGROUND
  • 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.

    PMID: 15963838BACKGROUND
  • 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.

    PMID: 39088685BACKGROUND
  • 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.

    PMID: 25372450BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Eisen, MD

    University of California, Davis - Dermatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Robb, BS, BA

CONTACT

Keemberly Kim, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Two blinded observers will record their scores independently using the POSAS instrument.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 1, 2024

Study Start

April 2, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations