PermeaDerm for Surgical Wounds

Recruiting at 11 trial locations

Overseen By Elizabeth Kirshner

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Avita Medical

Must not be taking: Corticosteroids, Chemotherapy, Immunosuppressants

Disqualifiers: Morbid obesity, Immunodeficiency, Diabetes, others

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

Compensation: Varies

Number of Visits: 2

Duration: 5-10 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two temporary dressings, PermeaDerm (a type of wound dressing) and a human cadaveric allograft, to determine which is more effective for patients requiring a skin graft after surgery. Researchers aim to identify which dressing attaches better to the skin, prepares the wound more quickly for a skin graft, and results in fewer complications. This trial may suit individuals with a surgical wound covering up to 30% of their body, who have been hospitalized within three days of injury and have not received previous surgical intervention on the wound area. As an unphased trial, it offers patients the chance to contribute to important research that could enhance wound care options.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot use medications like systemic corticosteroids, chemotherapy, or immunosuppressants during the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that PermeaDerm is a special type of wound dressing approved by the FDA for various wounds, including surgical ones. This approval confirms its safety for certain uses. Studies have found that PermeaDerm creates a moist environment that aids healing and can reduce complications.

In contrast, the Frozen Human Cadaveric Allograft (FHCA) serves as another temporary wound covering. Derived from donated human skin, FHCA protects wounds temporarily. Its safety has been proven over many years of medical use.

Both treatments have been used in various medical settings, indicating general safety. However, like any medical treatment, risks may exist. Participants should discuss possible side effects with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

PermeaDerm is unique because it acts as a temporary biosynthetic wound matrix, offering an innovative way to manage surgical wounds. Unlike traditional treatments that often involve skin grafts or dressings, PermeaDerm provides a synthetic option that can potentially integrate with the body's healing process more seamlessly. Researchers are excited about its potential to reduce healing time and improve outcomes by offering a more adaptable and less invasive approach compared to existing options. Additionally, the trial is also exploring the use of Frozen Human Cadaveric Allograft (FHCA), which is distinct because it uses human tissue to promote natural healing, potentially offering more effective integration with the patient's own skin.

What evidence suggests that this trial's treatments could be effective for surgical wounds?

This trial will compare PermeaDerm, a temporary biosynthetic wound matrix, with Frozen Human Cadaveric Allograft (FHCA) for surgical wounds. Research has shown that PermeaDerm can aid in wound healing by creating a favorable environment, typically within 7 to 14 days. One study found that more patients experienced healing with PermeaDerm by day 14 compared to other treatments, although the difference wasn't statistically significant. While specific data on PermeaDerm for surgical wounds is lacking, similar products have effectively treated these types of wounds. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients needing skin grafts due to various wounds like burns, ulcers, or surgical complications. Participants should require a temporary dressing before receiving a skin graft. Specific eligibility criteria are not provided but typically include general health requirements and consent to follow-up.

Inclusion Criteria

My surgery was within 5 days after my injury.

The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule

The patient (or parent/guardian/legally authorized representative) agrees to abstain from any other treatment of the study area or enrollment in another interventional clinical trial for the duration of his/her participation in the study (8 weeks post-autografting)

Exclusion Criteria

The patient is unable to understand English or Spanish

The patient has a known hypersensitivity to bovine-derived collagen materials, porcine, aloe vera materials, or contraindications to the frozen human cadaveric allograft

I don't have signs of infection in the study area that could risk my safety or affect the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 days

Treatment

Participants receive either PermeaDerm or FHCA as a temporary dressing, followed by autografting when ready

5-10 days

Every 2-3 days for wound evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with digital photography documentation

8 weeks

Regular clinic check-ups

What Are the Treatments Tested in This Trial?

Interventions

• PermeaDerm

Trial Overview The study compares two types of temporary dressings: PermeaDerm Biosynthetic Wound Matrix and Frozen Human Cadaveric Allograft (FHCA). It will assess cost-effectiveness, wound attachment, readiness for skin grafting, healing time, and any complications post-treatment.

How Is the Trial Designed?

Group I: PermeaDerm Temporary Biosynthetic Wound Matrix Experimental Treatment 1 Intervention

Group II: Frozen Human Cadaveric Allograft (FHCA) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Avita Medical

Lead Sponsor

Trials

18

Recruited

720+

Published Research Related to This Trial

The study developed two distinct outcome measures to evaluate the management of primary surgical wounds: one for healthcare professionals focusing on exudate and allergic reactions, and another for patients addressing comfort, dressing removal, and overall satisfaction.

These measures were created through a mixed-methods approach involving 64 patients and 15 healthcare professionals, ensuring they are relevant and acceptable, with each taking less than five minutes to complete.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing outcome measures assessing wound management and patient experience: a mixed methods study. Elliott, D.[2022]

In a study involving 150 patients with acute and chronic wounds, the Cutimed(®) Siltec foam dressing significantly improved exudate management and reduced maceration over a 4-month period.

The dressing also provided benefits such as atraumatic application and removal, reduced non-adherence, and enhanced patient experience, highlighting its effectiveness in wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

150 patient experiences with a soft silicone foam dressing. Bateman, SD.[2015]

Sepaderm®, a new wound management system, effectively treated various wound types, including a chronic venous ulcer that had previously not healed.

The system's design allows for easy use, effective removal of excess exudate, and protection of the wound bed, contributing to successful healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sepaderm for the management of acute and chronic wounds . Thibodeaux, K., Tam, SW.[2015]

Effective postoperative wound care is crucial for rapid healing and minimizing complications, emphasizing the need for optimal management practices by health professionals.

The new Leukomed Control dressing is highlighted for its transparency, flexibility, and breathability, which allows for extended wear and early wound assessment without frequent changes, potentially improving patient comfort and healthcare efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing surgical wound care: review of Leukomed Control dressings. Milne, J.[2016]

In a study involving 129 patients and 150 wounds, the use of Cutimed® Siltec® and Cutimed Siltec B dressings significantly reduced wound exudate and pain during dressing changes, indicating their effectiveness in wound management.

Both clinicians and patients reported high satisfaction with the dressings, rating their comfort, ease of use, and absorption capabilities as 'good' to 'very good', highlighting their potential for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicentre, observational evaluation of the product characteristics of two absorbent foam dressings. Seckam, A.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06750809

Study Details | NCT06750809 | Randomized Controlled ... The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin ...

2. avitamedical.com avitamedical.com/products-permeaderm/

PermeaDerm - AVITA Medical, Inc. Demonstrated clinical advantages. PermeaDerm creates an optimal environment to promote wound healing, typically within 7-14 days, after which it can be easily ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40341353/

A Randomized, Controlled Trial Comparing PermeaDerm ... Though not statistically significant, more patients achieved healing with PermeaDerm at day 14 (P = 0.36), particularly those with superficial partial-thickness ...

4. withpower.com withpower.com/trial/phase-wounds-and-injuries-2025-22ae3

PermeaDerm for Surgical Wounds While there is no direct data on PermeaDerm, similar treatments like Sepaderm have shown success in managing surgical wounds by effectively handling wound ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/RCEL/pressreleases/33149707/avita-medicals-study-on-permeaderm-a-potential-game-changer-in-wound-care/

Avita Medical's Study on PermeaDerm: A Potential Game ... ' The study aims to compare the clinical outcomes and costs of using PermeaDerm versus frozen human cadaveric allograft (FHCA) as temporary ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/K153678.pdf

August 8, 2016 PermeaDerm, Inc. c/o Aubrey Woodroof, Ph.D ... All configurations provide a moist wound healing environment with a slitted silicone/nylon membrane coated with gelatin and aloe vera extract.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4511025/

Evolution of a Biosynthetic Temporary Skin Substitute In vivo testing of temporary skin substitutes shows that after 14 days, healing of full-thickness dermal wounds in rats with a PermeaDerm ...