Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site

Overseen By Kathryn Bartz, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nebraska Methodist Health System

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Immunosuppression, Diabetes, Obesity, 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: 2

Duration: 4 weeks

5 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on high-dose steroids or other immunosuppressive medications, you may not be eligible to participate.

What data supports the effectiveness of the treatment Restrata Graft, Standard of Care Skin Graft?

The study on minced skin grafts for chronic wounds suggests that alternative grafting techniques can be effective, as they were found to be non-inferior to conventional methods. This implies that innovative grafting methods, like Restrata Graft, may also be effective in treating skin defects. ^{1 2 3 4 5}

How does the Standard of Care Skin Graft treatment differ from other treatments for skin defects?

The Standard of Care Skin Graft is unique because it uses the patient's own skin (autologous graft) as the gold standard for wound closure, which is often preferred for burns and chronic ulcers. However, when autologous grafts are not possible, skin substitutes are used as an alternative, making this treatment flexible in addressing the availability of donor skin. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial is testing whether using a special type of graft along with a skin graft helps adult patients heal better after certain forearm surgeries.

Research Team

Robert Lindau, MD

Principal Investigator

Nebraska Methodist Hospital

Eligibility Criteria

Inclusion Criteria

All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.

Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo radial or ulnar forearm free flap surgery with either standard care or Restrata graft

4 weeks

1 visit (in-person for surgery)

Follow-up

Participants are monitored for tendon exposure and skin graft incorporation

4 weeks

1 visit (in-person for assessment)

Treatment Details

Interventions

• Restrata Graft
• Standard of Care Skin Graft

Participant Groups

Group I: B - Restrata Graft Experimental Treatment 1 Intervention

Group II: A - Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Nebraska Methodist Health System

Lead Sponsor

Trials

3

Recruited

760+

Acera Surgical, Inc.

Industry Sponsor

Trials

7

Recruited

170+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Readability, reliability and credibility of online patient information on skin grafts. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Cost study of dermal substitutes and topical negative pressure in the surgical treatment of burns. [2014]

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

Minced skin grafts for chronic wounds compared to conventional mesh grafts. [2023]

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

Graft survival following living-donor renal transplantation: a comparison of tacrolimus and cyclosporine microemulsion with mycophenolate mofetil and steroids. [2021]

5. Australia pubmed.ncbi.nlm.nih.gov

Skin grafts: a rural general surgical perspective. [2019]

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

Calculation of practical skin donor area for meshed skin grafting in real-world surgery. [2021]

7. Iran pubmed.ncbi.nlm.nih.gov

Can Skin Allograft Occasionally Act as a Permanent Coverage in Deep Burns? A Pilot Study. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The dermis graft: another autologous option for acute burn wound coverage. [2013]

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

Skin grafting. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Which dressing do donor site wounds need?: study protocol for a randomized controlled trial. [2021]