Skin Subs vs Secondary Intention

Skin Substitutes Versus Secondary Intention Healing After Mohs Micrographic Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Substitutes; Secondary Intention Healing; Skin Cancer Healing
• Intervention / Treatment: Biological: Skin Substitute; Biological: Secondary Intention Healing

Detailed Description

This is a randomized-controlled trial comparing two ways of caring for wounds after Mohs micrographic surgery for skin cancer: skin substitutes, which are special wound-healing materials that may help wounds heal, and secondary intention healing, a common method in which wounds are allowed to heal on their own. This research is being done because we do not yet know which option leads to better healing after Mohs surgery. Patients will be randomized into one of two groups and receive either the skin substitute or undergo secondary intention healing.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Umer Nadir, MD; Phone Number: 214-820-2361; Email: umer.nadir@bswhealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Biological: Secondary Intention Healing; Standard secondary intention healing with daily wound care only.
Active Comparator: Intervention Group	Biological: Skin Substitute; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Wound Healing	Assess the amount of time to took for the wound to heal completely, also defined as full epithelialization. This will be compared using a t-test model or the Mann-Whitney U tests. A t-test model uses an standard statistic test that is used to determine if there is significant differences between two groups. The Mann-Whitney U tests is a rank-sum test that is used to determine if there is a difference between two different groups.	12 weeks
Pain Scores	Evaluate the patient-reported pain during the first 2 weeks of healing and weekly, at follow-up visits, until wound closure. Patients will verbally rating their pain on a scale of 1-10 where 1 is no pain and 10 is severe pain. Patient will keep a record of their daily pain levels and share the scores at their weekly follow-up visits.	12 weeks
Rate of Complications	To determine the rate of complication and assess for infection, bleeding, hypergranulation, and unplanned interventions. During the follow-up visits the physician will conduct a visual assessment for these items and will use a chi-square or Fisher's exact tests. A Chi-Square test is a statistical tool that is used to determine if there is a different between expected and observed frequences in one or more category. Fisher's exact test is a tool used to determine if there are non-random associations between two categorical variables.	12 weeks
Scar Appearance	To evaluate the patient-reported scar satisfaction by patients 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
Treatment-Related Resource Consumption	To evaluate the resource utilization and cost of the number of clinic visits by reviewing the patients electronic health record	12 weeks
Treatment-Related Resource Consumption	To evaluate the resource utilization and cost of dressing supplies by reviewing the patients electronic health record.	12 weeks
Patient Productivity Loss	To assess the loss of productivity due to patient-reported time off work, if feasible. This will be done by patients verbal self-report.	12 weeks

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Stan Tolkachjov, MD, Baylor Scott and White Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Equipment; Equipment and Supplies; Artificial Organs; Skin, Artificial
• Other Study ID Numbers: 026-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes