Skin Substitutes for Healing After Skin Cancer Surgery

Overseen By Umer Nadir, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Baylor Research Institute

Disqualifiers: Active infection, Severe immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to aid wound healing after Mohs surgery, a common procedure for skin cancer removal. One method uses a skin substitute, a product designed to replace or support the skin, while the other allows the wound to heal naturally through secondary intention healing. The goal is to determine which method results in better healing. Adults undergoing Mohs surgery who can manage daily wound care might be suitable for this trial. Participants must agree to have their wound progress photographed for the study. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that skin substitutes are generally safe after Mohs surgery for skin cancer. One study found that 36 patients experienced excellent results, with skin grafts taking successfully 95% to 99% of the time, and their wounds healed completely in about 31 days. Another study reported that 20 patients treated with a skin substitute called Hyalomatrix had no negative reactions, and their wounds healed well. These findings suggest that skin substitutes are well-tolerated and effective in promoting wound healing after surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about skin substitutes for healing after skin cancer surgery because they offer a promising new approach to wound healing. Unlike traditional methods such as secondary intention healing, which relies on the body's natural ability to close wounds over time, skin substitutes can provide immediate coverage and protection. These substitutes often include bioengineered materials that mimic natural skin, potentially speeding up the healing process and reducing complications like infections. This innovative approach could lead to faster recovery times and better cosmetic outcomes for patients.

What evidence suggests that this trial's treatments could be effective for healing after skin cancer surgery?

This trial will compare the effectiveness of skin substitutes with secondary intention healing for recovery after skin cancer surgery. Research has shown that skin substitutes can be highly effective for healing after Mohs surgery, a common procedure for skin cancer. Specifically, studies have found that these substitutes can lead to complete wound healing in about 31 days post-surgery. They accelerate healing, reduce pain and scarring, and protect against infection. In contrast, secondary intention healing, where wounds heal naturally, typically takes longer. On average, about 72.3% of wounds heal within 4 to 8 weeks using this method. Both approaches have their advantages, but skin substitutes might offer a quicker and more comfortable recovery. ^{4 6 7 8 9}

Who Is on the Research Team?

Stan Tolkachjov, MD

Principal Investigator

Baylor Scott and White Health

Are You a Good Fit for This Trial?

This trial is for people who have had Mohs surgery to remove skin cancer and need wound care afterward. Specific inclusion or exclusion criteria are not listed, but it generally applies to adults recovering from this type of surgery.

Inclusion Criteria

I am able to care for my wound daily and attend follow-up visits.

Willingness to consent to standardized medical photography

I am 18 or older and having Mohs surgery.

Exclusion Criteria

Known allergy to any component of the skin substitute

I have a severely weakened immune system that increases my risk for complications.

I have a wound that needs flap or graft surgery to heal properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either a skin substitute or undergo secondary intention healing after Mohs micrographic surgery

12 weeks

Weekly follow-up visits

Follow-up

Participants are monitored for cosmetic outcomes, complete wound healing, pain scores, rate of complications, scar appearance, treatment-related resource consumption, and patient productivity loss

12 weeks

Weekly follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Secondary Intention Healing
• Skin Substitute

Trial Overview

The study compares two ways to heal wounds after Mohs surgery: using a skin substitute (an artificial covering) versus letting the wound heal naturally on its own (secondary intention healing).

How Is the Trial Designed?

Group I: Control Group Active Control 1 Intervention

Group II: Intervention Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7950193/

Skin cancers and dermal substitutes: Is it safe? Review of the ...

Skin graft take was excellent (from 95% to 99%) in 36 patients, and complete wound healing was achieved in an average of 31 days after first surgery. Only ...

2.

dermatologyadvisor.com

dermatologyadvisor.com/news/skin-substitutes-effective-mohs-micrographic-surgery/

Skin Substitutes Are Effective in Mohs Micrographic Surgery

Skin substitutes may be associated with positive outcomes for Mohs micrographic surgery (MMS) among patients with cutaneous malignancy, according to study ...

3.

jaadinternational.org

jaadinternational.org/article/S2666-3287(25)00069-0/fulltext

Cosmetic and functional outcomes of excisional surgical ...

A total of 1655 surgical wounds, of which 1518 (91.7%) healed by SIH, from 35 studies, were included in this review. The most frequent ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5511644/

Dermal Substitutes Use in Reconstructive Surgery for Skin ...

Average time to second-stage skin grafting was 43.9 days. Three (23%) patients developed tumor recurrence and one died. Conclusions. Use of ...

5.

jcadonline.com

jcadonline.com/mohs-surgeons-postoperative-care-practices-for-secondary-intention-healing-a-national-survey/

Mohs Surgeons' Postoperative Care Practices for ...

Outcomes. On average, 72.3% of respondents reported complete healing within 4 to 8 weeks for all wounds undergoing SIH, regardless of location, while 15.7% ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07587749

NCT07587749 | Skin Subs vs Secondary Intention

This is a randomized-controlled trial comparing two ways of caring for wounds after Mohs micrographic surgery for skin cancer: skin substitutes, ...

7.

mohssurgery.org

mohssurgery.org/blog/uncategorized/healing-after-mohs-micrographic-surgery-how-skin-substitutes-can-help/

How Skin Substitutes Can Help

Healing After Mohs Micrographic Surgery: How Skin Substitutes Can Help ; Biologic substitutes come from human or animal tissue. Synthetic ...

8.

uhcprovider.com

uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/skin-soft-tissue-substitutes.pdf

Skin and Soft Tissue Substitutes

While cellular skin substitutes appear to benefit DFU healing over SWC alone, evidence on individual products to assess whether any particular ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7949901/

Reconstruction after skin cancer excision through a dermal ...

The 20 patients included in the protocol and treated by removing the skin cancer and application of Hyalomatrix were healed. No adverse reactions were ...