Health Condition 1: L984- Non-pressure chronic ulcer of skin, not elsewhere classified
Conditions
Interventions
Intervention1: Ovine Forestomach Matrix (OFM) products (Endoformâ?¢ Natural Dermal Template
Endoformâ?¢ Antimicrobial Dermal Template and Myriad Matrixâ?¢): a. Study design is single arm and no comparator agent involved.
b. Depend on Size of the wound (length, and width), investigator decid
Endoformâ?¢ Antimicrobial Dermal Template and Myriad Matrix.
c. Number of intervention, duration of treatment and reapplication will be determined by the Investigator and will depend upon the type of
Sponsors
Aroa Biosurgery Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients will be considered eligible for the study based on the following criteria: 1. Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan 2. Male or female patients aged 18 years or above 3. Patients with acute or chronic full thickness wounds, including deep partial burns
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study based on the following criteria: 1. Patients with known sensitivity to ovine (sheep) derived material 2. Patients with known sensitivity to ionic silver 3. Patients with third degree burns 4. Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade equal to 4), acute inflammation, excessive exudate, or bleeding 5. Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study 6. Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment 7. Pregnant or lactating women 8. Patients with suspected signs and symptoms of COVID-19 Or confirmed novel coronavirus infection (COVID-19)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with treatment emergent adverse events during the studyTimepoint: Minimum 03 weeksâ?? time required to confirm wound assessment and imaging from baseline to wound closure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion (%) of participants with complete wound closure (defined as 100% skin re-epithelialization without drainage or dressing requirements, confirmed at 2 week follow-up) Time (weeks) to complete wound closure Time (weeks) to 100% granulation of Myriad Matrixâ?¢% Split thickness skin graft (STSG) taken at 1 week post Myriad Matrixâ?¢ application (where applicable) Timepoint: Minimum 03 weeksâ?? time required to confirm wound assessment and imaging from baseline to wound closure. | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed