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

Not Applicable

Active, not recruiting

• Conditions: Non-pressure chronic ulcer of skin, not elsewhere classified,

• Registration Number: CTRI/2022/01/039714
• Lead Sponsor: Aroa Biosurgery Limited

Brief Summary

This is a prospective, multi-center, single arm, Phase IV study, designed to evaluate the safety and efficacy of Ovine Forestomach Matrix (OFM) products (Endoformâ„¢ Natural Dermal Template; Endoformâ„¢ Antimicrobial Dermal Template and Myriad Matrixâ„¢) in acute or chronic wound.

Patients with acute or chronic full thickness wounds, including deep-partial burns will be identified.  The study wound will be identified (1 wound per patient) and debridement will be done. Two applications of Endoformâ„¢ Antimicrobial Dermal Template will be applied per week. The device can be applied for a minimum one week and maximum two weeks as per Investigator’s discretion. After that, if required, debridement will be done. One application of Endoformâ„¢ Natural Dermal Template will be done for one week. After a week of its application, surgical placement of Myriad Matrixâ„¢ will be done.

The study will commence only after obtaining written approval from the Indian Regulatory (Central Drugs Standard Control Organization) and site Institutional Ethics Committee.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 100

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 study	Minimum 03 weeks’ 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%	skin re-epithelialization without drainage or dressing requirements, confirmed at 2 week follow-up)

Trial Locations

Locations (4)

All India Institute of Medical Sciences; 🇮🇳 Bhadrak, ORISSA, India

K R Hospital; 🇮🇳 Mysore, KARNATAKA, India

Sir Sayaji General Hospital; 🇮🇳 Vadodara, GUJARAT, India

Sri Guru Ramdas Institute of Medical Science and Research; 🇮🇳 Amritsar, PUNJAB, India

All India Institute of Medical Sciences

🇮🇳Bhadrak, ORISSA, India

Dr Ritesh Panda

Principal investigator

9999326904

dr.riteshpanda@gmail.com