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CTRI Number  CTRI/2024/02/062997 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Use of NovoSorb BTM to determine if Safe and Effective in Burn Treatment  
Scientific Title of Study   A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CP003v4.0 dated 22/07/2022  Protocol Number 
NCT04090424  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Raja Sabapathy 
Designation  Chairman, Division of Plastic Surgery, Hand Surgery, Reconstructive Microsurgery and Burns  
Affiliation  Ganga Medical Centre and Hospitals PVT Ltd  
Address  Department of Plastic Surgery, Hand and Reconstructive Microsurgery Surgery and Burns 313 Mettupalayam Road

Coimbatore
TAMIL NADU
641043
India 
Phone  914222485000  
Fax  914222436444   
Email  rajahand@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anand Shastri 
Designation  Medical Director PolyNovo India 
Affiliation  PolyNovo Biomaterials India Private Limited 
Address  907, 9th Floor, Meraki Arena VN Purav Marg Opp RK Studio, Chembur

Mumbai
MAHARASHTRA
400071
India 
Phone  8291880580  
Fax    
Email  anand.s@polynovo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashoka Singh 
Designation  Clinical Project Manager  
Affiliation  Clinnex 
Address  1204, Shilp Epitome, Bodakdev

Ahmadabad
GUJARAT
380054
India 
Phone  917946048633  
Fax    
Email  ashoka.singh@clinnex.com  
 
Source of Monetary or Material Support  
Biomedical Advanced Research and Development Authority (BARDA) 200 Independence Ave. Washington, DC 20201 
 
Primary Sponsor  
Name  PolyNovo Biomaterials Pty Ltd 
Address  2320 Lorimer Street Port Melbourne 3207, Victoria, Australia 
Type of Sponsor  Other [Medical Device Manufacturer-Global] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Canada
India
United States of America  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramakant Haribhau Bembde  Bembde Hospital   Department Plastic & Cosmetic Surgery, Plot No 14 Beed Bypass Road
Aurangabad
MAHARASHTRA 		 918805013088

drbembde@gmail.com 
Dr S Raja Sabapathy  Ganga Medical Centre and Hospitals PVT Ltd   Department of Plastic Surgery, Hand and Reconstructive Microsurgery and Burns, 313 Mettupalayam Road
Coimbatore
TAMIL NADU 		 919842219338

rajahand@gmail.com 
Dr Sunil Manohar Keswani   National Burns Centre  Department of Cosmetic and Burn Surgery, Plot No:1 Sector 13 Airoli Navi
Mumbai
MAHARASHTRA 		 912227796660

smkeswani@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Bembe Hospital  Approved 
Ganga Hospital Ethics Committee  Approved 
Institutional Ethics Committee-NBC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T310||Burns involving less than 10% of body surface, (2) ICD-10 Condition: T311||Burns involving 10-19% of body surface, (3) ICD-10 Condition: T312||Burns involving 20-29% of body surface, (4) ICD-10 Condition: T313||Burns involving 30-39% of body surface, (5) ICD-10 Condition: T314||Burns involving 40-49% of body surface, (6) ICD-10 Condition: T315||Burns involving 50-59% of body surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Integra® or Cadaveric allograft  Integra® is a bilayer membrane dermal substitute made of animal-derived collagen and glycosaminoglycan. Cadaveric allograft is a biological dressing of human meshed skin graft obtained from a deceased donor. The investigator will select which comparator agent to be used then implant and a fixed agent into position to close a debrided burn wound. When clinically ready, the comparator agent will be removed and the split skin graft is applied. The total duration of intervention will be 5 weeks. 
Intervention  NovoSorb BTM   BTM is a synthetic, sterile, integrating dermal matrix composed of a porous biodegradable polyurethane foam and a temporary epidermal barrier component. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied. The total duration of intervention will be 5 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Provides written informed consent directly or via legally authorized representative (LAR) prior to any clinical study procedures being performed.
2. Willing to comply with all study procedures and expects to be available for the duration of the study.
3. Male and female, 18 to 75 years of age.
4. Has deep dermal or full thickness thermal burns between 3% and 60% inclusive of their TBSA. The % TBSA will be determined using the Lund and Browder chart. The types of burns that will be assessed will include the following:• Scald including hot water, cooking oil, grease, etc.• Flame• Flash• Contact.
5. Has staged surgical procedures planned, e.g., one procedure to excise the burn eschar and a later procedure to prepare the wound bed and apply an autologous skin graft.
6. The minimum total area across all lesions to have NovoSorb BTM applied is 3% TBSA.
7. Females who are non-pregnant, i.e., has a negative pregnancy test at Day 0, prior to NovoSorb BTM being applied, non-breastfeeding, or are naturally postmenopausal, i.e., greater than 12 months of natural spontaneous amenorrhea or surgically sterile. If of childbearing potential, agrees to use effective contraceptive methods throughout the course of the study.  
 
ExclusionCriteria 
Details  1. Has a known hypersensitivity to polyurethane
2.Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn or crush, i.e., road rash
3. Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin
4. Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy
5. Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound
6. For females - has known or suspected pregnancy, planned pregnancy, or during lactation
7. Has exposure to any other investigational agent within the last 6 months
8. Has exposure to any other treatment or device that will interfere with NovoSorb® BTM integration
9. Anticipated inability to perform wound care and follow-up procedures
10. Anticipates a level of non-compliance
11. The use of off-label treatments for full-thickness or deep-dermal burns is not permitted
12. Clinical signs of wound infection at areas to be potentially treated using NovoSorb® BTM that in the opinion of the investigator may compromise safety and study objectives
13. The use of NovoSorb® BTM on the face and in the perineum area is not permitted 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of study lesions in both groups with complete wound closure after skin grafting. Assessment of clinical outcome by wound closure   4 weeks after skin grafting  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/09/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a multicenter randomized clinical study to assess the safety and effectiveness of NovoSorb Biodegradable Temporizing Matrix (BTM) to treat patients with deep dermal or full thickness burns resulting from flame, flash, contract or scalding. Patients, 18 to 75 years of age, who have burns from 3% to 60%, inclusive, of their total body surface (TSBA) will be randomized to either the NovSorb BTM treatment group or the Standard of Care treatment group. The total number of patients to be enrolled in the global study is 150, India enrolled  is to be 30. Study enrollment in India is expected to start in February of 2024. Subject participation, treatment  plus follow-up period is approximately 20 months. 
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