Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures (NCT07385313) | Clinical Trial Compass
RecruitingPhase 4
Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
United States30 participantsStarted 2026-03-31
Plain-language summary
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
Who can participate
Age range18 Years
SexALL
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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 periphe…