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Skin SubstitutesPhase 4NCT07587749

Skin Subs vs Secondary Intention

A Phase 4 study testing Skin Substitute and Secondary Intention Healing in people with Skin Substitutes and Secondary Intention Healing, run by Baylor Research Institute at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Skin Substitute and Secondary Intention Healing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Jan 2027to Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Umer Nadir, MD contact

214-820-2361

umer.nadir@bswhealth.org

United States1 site

  • Baylor University Medical Center

    Dallas, Texas, 75246

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Skin Substitute, Secondary Intention Healing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Secondary Intention HealingBiological

    Standard secondary intention healing with daily wound care only.

Study groups in NCT07587749
Study groupRoleWhat they receive
Intervention GroupActive comparatorNot described
Receives: Biological: Skin Substitute
Control GroupActive comparatorNot described
Receives: Biological: Secondary Intention Healing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 12 weeks

Secondary outcomes (7)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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".

    Measured: 12 weeks

  5. Treatment-Related Resource Consumption

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

    Measured: 12 weeks

  6. Treatment-Related Resource Consumption

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

    Measured: 12 weeks

  7. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07587749
Sponsor's protocol ID
026-109
Status last verified
Oct 2026
First submitted
5 May 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 36924081

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Skin Substitute and Secondary Intention Healing in people with Skin Substitutes and Secondary Intention Healing, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Umer Nadir, MD (214-820-2361, umer.nadir@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cosmetic Outcome Assessments (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07587749, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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