Restrata + Skin Graft for Forearm Reconstruction

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to aid forearm healing after a specific type of surgery. Researchers are testing whether the Restrata graft, combined with a standard skin graft, can enhance healing. Participants will be divided into two groups: one will receive the standard skin graft, while the other will receive the Restrata graft. The trial seeks adults who require a specific forearm surgery and can have photos taken to document their healing progress. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in surgical healing.

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.

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

Research has shown that the Restrata graft is generally safe for people and aids in healing various wounds, including challenging ones like diabetic foot ulcers. Studies have found that it promotes healing without causing major side effects. However, Restrata has not been tested on wounds that reach deep into muscles or bones. So far, studies have not reported any major safety issues, suggesting that Restrata is safe for most people to use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Restrata Graft because it offers a unique approach to healing donor sites on the forearm. Unlike the standard split-thickness skin graft, which relies on transferring skin from one area of the body to another, Restrata is a bioengineered skin substitute. This innovative treatment aims to enhance healing by providing a scaffold that supports the body's natural repair processes, potentially reducing complications and improving recovery time. By focusing on these aspects, Restrata could offer a more efficient and comfortable healing experience compared to traditional methods.

What evidence suggests that the Restrata graft is effective for forearm flap reconstruction?

Research has shown that the Restrata graft, tested in this trial, may enhance wound healing. In one study, 96% of wounds treated with Restrata healed completely, taking about 96 days on average and leaving minimal scars. Another report found that a wound was ready for a skin graft just four weeks after using Restrata. Additionally, wounds with exposed areas healed sufficiently in about 5.2 weeks. These findings suggest that Restrata could improve healing when used with a split-thickness skin graft. Participants in this trial will receive either the Restrata graft or the standard of care skin graft to compare their effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

Robert Lindau, MD

Principal Investigator

Nebraska Methodist Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Restrata Graft
• Standard of Care Skin Graft

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10790141/

Utility of a Synthetic Hybrid-Scale Fiber Matrix in Surgical ... The average time to achieve sufficient regranulation over exposed structures was 5.2 weeks across all wound etiologies. These results are ...

2. acera-surgical.com acera-surgical.com/restratasheet/

Restrata Synthetic Electrospun Fiber Matrix Sheet Full closure was achieved in 10 weeks. ... Patient developed a healthy granulation base and received a split-thickness skin graft (STSG) 4 weeks post Restrata ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S266739672100077X

Lower extremity wounds treated with a synthetic hybrid ... 96% (n = 22) of the wounds demonstrated complete healing. The average time to heal was 96.1 days, with minimal scar formation. The majority of the wounds only ...

4. fastracjournal.org fastracjournal.org/article/S2667-3967(24)00002-8/fulltext

A prospective, blinded, randomized controlled clinical trial ... The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06578650

Study Details | NCT06578650 | A Prospective, Single-arm ... This study intends to quantify the time from initial resection and product application to time of complete granulation of the wound bed in weeks. Official Title.

6. acera-surgical.com acera-surgical.com/

Acera Surgical Inc. **Disclaimer: Restrata has not been studied in wounds that extend into the tendon, muscle, joint capsule, or bone. Please refer to the Product's Instructions ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K193583.pdf

December 15, 2022 Acera Surgical, Inc. President/CEO ... Restrata® is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores/ ulcers, venous ulcers, ...

8. acera-surgical.com acera-surgical.com/restratameshed/

Restrata :: Acera Surgical Inc. Proven to provide healing in refractory wounds1, suitable for patients with ethical or religious objections to skin grafts, and without the special storage and ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/95/NCT03312595/Prot_SAP_000.pdf

Clinical Outcomes After Treatment with RestrataTM Wound ... the following study is evaluate the initial safety and effectiveness of Restrata™. Wound Matrix in treating diabetic foot ulcers in human subjects, and to ...