Study to evaluate the safety and efficacy of Ovine Forestomach Matrix (OFM) products in acute or chronic wound.

Phase 4

Conditions: Health Condition 1: L984- Non-pressure chronic ulcer of skin, not elsewhere classified

Registration Number: CTRI/2022/01/039714

Lead Sponsor: Aroa Biosurgery Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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)

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion (%) of participants with complete wound closure (defined as 100% <br/ ><br>skin re-epithelialization without drainage or dressing requirements, confirmed at 2 week follow-up) <br/ ><br>Time (weeks) to complete wound closure <br/ ><br>Time (weeks) to 100% granulation of Myriad Matrixâ?¢% Split thickness skin graft (STSG) taken at 1 week post Myriad Matrixâ?¢ application (where applicable) <br/ ><br>Timepoint: Minimum 03 weeksâ?? time required to confirm wound assessment and imaging from baseline to wound closure.