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NCT Number: NCT07587749

Skin Subs vs Secondary Intention

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.

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Key information

Conditions

Skin Substitutes Secondary Intention Healing Skin Cancer Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin Substitute

Biological

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.

Secondary Intention Healing

Biological

Standard secondary intention healing with daily wound care only.

Primary outcomes

  1. Cosmetic Outcome Assessments

    Time frame: 12 weeks

    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".

Secondary outcomes

  1. Complete Wound Healing

    Time frame: 12 weeks

    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.

  2. Pain Scores

    Time frame: 12 weeks

    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.

  3. Rate of Complications

    Time frame: 12 weeks

    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.

  4. Scar Appearance

    Time frame: 12 weeks

    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".

  5. Treatment-Related Resource Consumption

    Time frame: 12 weeks

    To evaluate the resource utilization and cost of the number of clinic visits by reviewing the patients electronic health record

  6. Treatment-Related Resource Consumption

    Time frame: 12 weeks

    To evaluate the resource utilization and cost of dressing supplies by reviewing the patients electronic health record.

  7. Patient Productivity Loss

    Time frame: 12 weeks

    To assess the loss of productivity due to patient-reported time off work, if feasible. This will be done by patients verbal self-report.

Study contacts

Contact information is provided by the study sponsor or research team.

Umer Nadir, MD

CONTACT

[email protected]

214-820-2361

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

Skin Substitutes Versus Secondary Intention Healing After Mohs Micrographic Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.