Clinical trial · Interventional
Skin Subs vs Secondary Intention
Skin Substitutes Versus Secondary Intention Healing After Mohs Micrographic Surgery
NCT07587749CI-TRIAL-00111575not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Secondary Intention Healing | — | UNRESOLVED | — |
| Skin Cancer Healing | — | UNRESOLVED | — |
| Skin Substitutes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Secondary Intention Healing | Biological | — | UNRESOLVED |
| Skin Substitute | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention Group
- interventionNames
- Biological: Skin Substitute
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- interventionNames
- Biological: Secondary Intention Healing
Primary outcomes (1)
- measure
- Cosmetic Outcome Assessments
- timeFrame
- 12 weeks
- description
- 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".
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDAd 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 22959232
- BACKGROUNDAlrubaiy 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
- BACKGROUNDEsmaeili 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