Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAroa Biosurgery Limited
About this trial
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Myriad™ applied in conjunction with NPWT
- NPWT Alone
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Aroa Biosurgery Limited
Lead sponsor
Coalition for National Trauma Research
Collaborator
Source ClinicalTrials.gov