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CTRI Number  CTRI/2022/01/039714 [Registered on: 25/01/2022] Trial Registered Prospectively
Last Modified On: 02/06/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Study to evaluate the safety and efficacy of Ovine Forestomach Matrix (OFM) products in acute or chronic wound. 
Scientific Title of Study   A prospective, multi-center, single arm, post-marketing study 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. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
CIP.AROA.001 Version .01 dated 27/Sep/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Vice President – Clinical Operations 
Affiliation  CBCC Global Research LLP  
Address  Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, Gujarat – 382210, India

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Vice President – Clinical Operations 
Affiliation  CBCC Global Research LLP  
Address  Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, Gujarat – 382210, India

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Vice President – Clinical Operations 
Affiliation  CBCC Global Research LLP  
Address  Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, Gujarat – 382210, India

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Aroa Biosurgery Limited 2 Kingsford Smith Place, Airport Oaks Auckland, 2022 New Zealand  
 
Primary Sponsor  
Name  Aroa Biosurgery Limited 
Address  2 Kingsford Smith Place, Airport Oaks Auckland, 2022 New Zealand  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ritesh Panda  All India Institute of Medical Sciences  Department of Trauma and Emergency, (Burns and Plastic surgery), AIIMS, Bhubaneswar, All India Institute of Medical Sciences, Sijua, Patrapada, Khordha, Bhubaneswar-751019, Odisha, India
Bhadrak
ORISSA 		 9999326904

dr.riteshpanda@gmail.com 
Dr Mohan Kakola  K R Hospital  Room No 3, 1st floor, Department of Plastic, Reconstructive & Burns Surgery, KR Hospital, Mysore Medical College and Research Institute, Irwin Road, Mysuru-570001, Karnataka, India
Mysore
KARNATAKA 		 9448064367

mohan_kakola@hotmail.com 
Dr Salesh Kumar Soni   Sir Sayaji General Hospital  Department of Plastic Surgery, Sir Sayaji General Hospital, Medical College- Baroda, Jail Road, Indira Avenue, Vadodara-390001, Gujarat, India.
Vadodara
GUJARAT 		 9825055083

drsksoni1985@gmail.com 
Dr Jasleen Kaur   Sri Guru Ramdas Institute of Medical Science and Research  Department of Dermatology, Sri Guru Ramdas Institute of Medical Science and Research, VPO Vallah, Mehta Road, Amritsar – 143006, Punjab, India.
Amritsar
PUNJAB 		 8727088096

jasleen1972@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
IEC-MMC and RI and Associated Hospital  Approved 
Institutional Ethics Committee for Human Research, Medical College, Baroda,   Approved 
Institutional Ethics Committee SGRDIMSAR   Approved 
Institutional Ethics Committee, AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L984||Non-pressure chronic ulcer of skin, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NONE 
Intervention  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 decide the Intervention of devise required Natural Dermal Template; 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 the wound and its condition.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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)
 		 Minimum 03 weeks’ time required to confirm wound assessment and imaging from baseline to wound closure. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   04/02/2022 
Date of Study Completion (India) 24/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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