PermeaDerm for Surgical Wounds

Recruiting at 8 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

Trial Summary

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.

What data supports the effectiveness of the treatment 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 exudate (fluid that leaks from wounds) and promoting healing. Additionally, other dressings like Cutimed Siltec have been positively evaluated for their ability to manage exudate and improve patient comfort, suggesting that PermeaDerm might offer similar benefits. ^{1 2 3 4 5}

What is the purpose of this trial?

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 graft to heal their wound. The researchers will review cost and other treatment results including how well both temporary dressings attach to the skin, how prepared the wound bed is to receive a skin graft, how long it takes for the skin to be ready to receive a skin graft, how well the skin graft takes and any complications. Patients will first have the temporary dressing applied to their wound, then a few days later, a skin graft will be performed. Patients will have photos of their wounds taken throughout the study including at all the clinic check-ups with the last check-up occurring about 8 weeks after treatment.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Sepaderm for the management of acute and chronic wounds . [2015]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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