NCT07587749

Brief Summary

The purpose of this study is to compare two ways of caring for wounds after Mohs micrographic surgery (MMS) for skin cancer using skin substitutes and secondary intention healing, to determine which option leads to better healing after Mohs surgery.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
18mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 5, 2026

Last Update Submit

May 11, 2026

Conditions

Skin SubstitutesSkin Cancer HealingSecondary Intention Healing

Outcome Measures

Primary Outcomes (1)

  • Cosmetic Outcome Assessments

    Compare cosmetic outcomes at 12 weeks between wounds treated with (1) a skin substitute and (2) secondary intention healing alone. This will be done by a group of blinded independent reviewers using standardized photographs and the Patient and Observer Scar Assessment Scale (POSAS), which evaluates scar quality using a scale of 1-10, where 1 is "like normal skin" and 10 is the "worst imaginable".

    12 weeks

Secondary Outcomes (7)

  • Complete Wound Healing

    12 weeks

  • Pain Scores

    12 weeks

  • Rate of Complications

    12 weeks

  • Scar Appearance

    12 weeks

  • Treatment-Related Resource Consumption

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR
Biological: Skin Substitute

Control Group

ACTIVE COMPARATOR
Biological: Secondary Intention Healing

Interventions

Skin SubstituteBIOLOGICAL

Application of a commercially available skin substitute (e.g., acellular dermal matrix or fish-skin xenograft) to the wound base followed by routine daily wound care.

Intervention Group
Secondary Intention HealingBIOLOGICAL

Standard secondary intention healing with daily wound care only.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Adults 18 and older undergoing Mohs micrographic surgery
  • Wounds deemed clinically appropriate for secondary intention healing
  • Ability to adhere to daily wound care and follow-up visits
  • Willingness to consent to standardized medical photography

You may not qualify if:

  • Wounds requiring flap or graft reconstruction for structural/functional reasons
  • Active wound infection at time of reconstruction
  • Known allergy to any component of the skin substitute
  • Severe immunosuppression in which either approach may pose undue risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (3)

  • Ad Hoc Task Force; Connolly SM, Baker DR, Coldiron BM, Fazio MJ, Storrs PA, Vidimos AT, Zalla MJ, Brewer JD, Smith Begolka W; Ratings Panel; Berger TG, Bigby M, Bolognia JL, Brodland DG, Collins S, Cronin TA Jr, Dahl MV, Grant-Kels JM, Hanke CW, Hruza GJ, James WD, Lober CW, McBurney EI, Norton SA, Roenigk RK, Wheeland RG, Wisco OJ. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012 Oct;67(4):531-50. doi: 10.1016/j.jaad.2012.06.009. Epub 2012 Sep 5.

    PMID: 22959232BACKGROUND

  • Alrubaiy L, Al-Rubaiy KK. Skin substitutes: a brief review of types and clinical applications. Oman Med J. 2009 Jan;24(1):4-6. doi: 10.5001/omj.2009.2.

    PMID: 22303500BACKGROUND

  • Esmaeili A, Biazar E, Ebrahimi M, Heidari Keshel S, Kheilnezhad B, Saeedi Landi F. Acellular fish skin for wound healing. Int Wound J. 2023 Sep;20(7):2924-2941. doi: 10.1111/iwj.14158. Epub 2023 Mar 16.

    PMID: 36924081BACKGROUND

MeSH Terms

Interventions

Skin, Artificial

Intervention Hierarchy (Ancestors)

Artificial OrgansSurgical EquipmentEquipment and Supplies

Study Officials

  • Stan Tolkachjov, MD

    Baylor Scott and White Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Umer Nadir, MD

CONTACT

214-820-2361umer.nadir@bswhealth.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 14, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)