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Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical Wounds

NCT06750809 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-11

No results posted yet for this study

Summary

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.

Conditions

  • Surgical Wound
  • Trauma Wound
  • Autografts
  • Partial-thickness Burn
  • Partial Thickness Wounds

Interventions

DEVICE

PermeaDerm Biosynthetic Wound Matrix

Study participants randomized (1:1) to this arm will receive PermeaDerm Biosynthetic Wound Matrix prior to skin graft.

DEVICE

Frozen Human Cadaveric Allograft (FHCA)

Study participant randomized (1:1) to this arm will receive Frozen Human Cadaveric Allograft (FHCA) prior to skin graft.

Sponsors & Collaborators

  • Avita Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750809 on ClinicalTrials.gov