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Not yet recruiting NCT07587749

Skin Subs vs Secondary Intention

Phase IV Interventional Skin Substitutes Secondary Intention Healing Skin Cancer Healing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Skin Substitute, Secondary Intention Healing.
Who it may be relevant to
Registry conditions: Skin Substitutes, Secondary Intention Healing, Skin Cancer Healing. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Skin Substitutes Versus Secondary Intention Healing After Mohs Micrographic Surgery

Overview

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.

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.

Interventions

  • 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.
  • Biological Secondary Intention Healing
    Standard secondary intention healing with daily wound care only.

Primary outcome measures

  • Cosmetic Outcome Assessments [Time frame: 12 weeks]
Secondary outcome measures (7)
  • Complete Wound Healing [Time frame: 12 weeks]
  • Pain Scores [Time frame: 12 weeks]
  • Rate of Complications [Time frame: 12 weeks]
  • Scar Appearance [Time frame: 12 weeks]
  • Treatment-Related Resource Consumption [Time frame: 12 weeks]
  • Treatment-Related Resource Consumption [Time frame: 12 weeks]
  • Patient Productivity Loss [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Baylor University Medical Center — Dallas

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 microg PMID 22959232
  • 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 22303500
  • 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 36924081

Identifiers

NCT: NCT07587749 · 026-109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗