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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Myriad™ applied in conjunction with NPWT
DeviceMyriad™ applied in conjunction with NPWT ('Myriad+NPWT')
NPWT Alone
DeviceControl Arm: NPWT alone ('NPWT')
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Interventional ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Tissue Coverage
Time (days) to complete tissue coverage of the exposed structure
Time frame
Up to 56 days/ 8 week follow upSecondary outcomes
1
Complete coverage of exposed structures
Percent of defects with complete coverage of exposed structures by 4 weeks
Time frame
up to 28 days (4 weeks)2
Post operative complications
Percent of patients with post operative complications (defined as seroma, hematoma, minor infection (cellulitis), major infection (requiring additional surgical intervention, incision and drainage, debridement, additional usage of/change in antibiotic therapy), or skin necrosis/dehiscence)
Time frame
Up to 56 days/ 8 week follow up3
NPWT Usage
Length of Negative Pressure Wound Therapy (NPWT) usage (days)
Time frame
Up to 56 days/ 8 week follow up4
Wound depth infill
Rate of depth infill (mm per week)
Time frame
56 days/up to 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aroa Biosurgery Limited
Lead sponsor
Coalition for National Trauma Research
Collaborator
Source ClinicalTrials.gov