NCT07385313 Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
| NCT ID | NCT07385313 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Aroa Biosurgery Limited |
| Condition | Soft Tissue Defects |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2026-03-31 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
Eligibility Criteria
Inclusion Criteria: * Patients will be considered eligible for the study based on the following criteria: * Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan * Male or female patients aged 18 years or above * Patient is requiring reconstruction of a full thickness soft tissue defect, that includes exposed structures (bone, tendon, or neurovascular), upper or lower extremity. * Total defect size, range 25 to 800 cm2 Exclusion Criteria: * Patients will be excluded from the study based on the following criteria: * Patients with known sensitivity to ovine (sheep) derived material * Pregnant or lactating females. * Patients who are prisoners. * Patients who are likely not to complete the study. * Patients who, in the opinion of the Investigator, are unlikely to comply with the protocol. * Patients currently participating in or have participated in another clinical study within the past 30 days prior to enrolment that at the discretion of the Investigator makes them unsuitable for inclusion in the study. * Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study. * Any medical condition, recent treatment or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study. * Obesity (BMI\>45) * Blood glucose ≥350 mg/dL at admission * History of chronic peripheral vascular disease * Current immunosuppression * Recent neoadjuvant chemotherapy or radiotherapy * Previous or concurrent application of a cell/tissue-based product (CTP, or skin substitute) at the wound site within 30 days of the Screening Visit * Defect is a third degree burn
Contact & Investigator
Julie Rizzo, MD
PRINCIPAL INVESTIGATOR
Brooke Army Medical Center
Frequently Asked Questions
Who can join the NCT07385313 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Defects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07385313 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07385313 currently recruiting?
Yes, NCT07385313 is actively recruiting participants. Contact the research team at Lizette@NatTrauma.org for enrollment information.
Where is the NCT07385313 trial being conducted?
This trial is being conducted at Aurora, United States, San Antonio, United States.
Who is sponsoring the NCT07385313 clinical trial?
NCT07385313 is sponsored by Aroa Biosurgery Limited. The principal investigator is Julie Rizzo, MD at Brooke Army Medical Center. The trial plans to enroll 30 participants.