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CTRI Number  CTRI/2024/02/062445 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 19/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Post-market clinical follow-up registry study for Surgi-ORC® Haemostats 
Scientific Title of Study   A prospective, open label, multi-center, single-arm, observational post-market clinical follow-up registry study to evaluate the safety and performance of absorbable, oxidized regenerated cellulose hemostat - Surgi-ORC®. 
Trial Acronym  NIL 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhinav Bhatnagar  
Designation  Orthopedics Surgeon 
Affiliation  Abhinav Multispecialty Hospital.  
Address  Abhinav Multispecialty Hospital, First floor, Room no. 1, Orthopedic department 10 no. puliya opp swastik school lashari Bagh Nagpur Maharashtra - 440017
Abhinav Multispecialty Hospital, First floor, Room no. 1, Orthopedic department 10 no. puliya opp swastik school lashari Bagh Nagpur Maharashtra - 440017
Nagpur
MAHARASHTRA
440017
India 
Phone  9823233634  
Fax  0712-2641317  
Email  b_abhinav@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Piyush Patel 
Designation  Quality Head 
Affiliation  Aegis Lifesciences Private Limited 
Address  Aegis Lifesciences Private Limited, 215/216 Mahagujarat Ind. Estate, Ahmedabad, India 382213

Ahmadabad
GUJARAT
382213
India 
Phone  9898791189  
Fax    
Email  qc.aegis@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Piyush Patel 
Designation  Quality Head 
Affiliation  Aegis Lifesciences Private Limited 
Address  Aegis Lifesciences Private Limited, 215/216 Mahagujarat Ind. Estate, Ahmedabad, India 382213


GUJARAT
382213
India 
Phone  9898791189  
Fax    
Email  qc.aegis@gmail.com  
 
Source of Monetary or Material Support  
Aegis Lifesciences Pvt. Ltd. 215/216, Mahagujarat Industrial Estate, Sarkhej-Bavla Road, Moraiya, Ta: Sanand, Dist.: Ahmedabad – 382213, Gujarat, India  
 
Primary Sponsor  
Name  Aegis Lifesciences Pvt. Ltd. 
Address  Aegis Lifesciences Pvt. Ltd. 215 and 216 Mahagujarat Industrial Estate Sarkhej Bavla Road Moraiya Sanand Ahmedabad 382213 
Type of Sponsor  Other [Medical device Manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhinav Bhatnagar   Abhinav Multispecialty Hospital Pvt. Ltd.   Abhinav Multispecialty Hospital, First floor, Room no. 1, Orthopedic department 10 no. puliya opp swastik school lashari Bagh Nagpur Maharashtra - 440017
Nagpur
MAHARASHTRA 		 0712-2641715
0712-2641317
b_abhinav@hotmail.com 
Dr Monika Jindal  Shri shankaracharya Institute of medical sciences Bhilai Durg   Department of OBG and Gynec, Ground Floor gynec OPD, Shri shankaracharya institute of medical sciences, junwani road Bhilai Durg Chhattisgarh 490020
Durg
CHHATTISGARH 		 8224014666

drmonickajindal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Shri Shankaracharya Institute of Medical Sciences Junwani Bhilai Junwani Durg Chhattisgarh - 490020 India  Approved 
Jasleen Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Used in all except those who are having known allergy to cellulose
2. Patient or their LDR is willing to sign Informed Consent Form (ICF)
3. Patients undergoing following surgeries: Abdominal Surgery, Gynecological Surgery, Partial Nephrectomy, Anorectal Surgery, Hysterectomy, Plastic Surgery, Dental Surgery, Neuro Surgery, Cardiovascular Surgery, ENT surgery, Orthopedic Surgery, Spinal Surgery, Genito Urinary Surgery, Otolaryngological Surgery, Tumor Surgery, Hepatic Surgery, Ophthalmic Surgery, Cardiothoracic Surgery, General Surgery, Obstetrics Surgery, Urologic Surgery.
4. Patient is willing to comply with the requirements given in ICF including the requirements for participating till last follow-up.
 
 
ExclusionCriteria 
Details  1. Haemostat to be used for packing and wadding without removal after hemostasis is achieved.
2. Haemostat to be used for implantation in bone defects, such as fractures, which may interfere with callus formation and may cause cyst formation.
3. Removal of haemostat is not possible after achieving hemostasis in or around foramina in bone, areas of bony confine, the spinal cord or the optic nerve and chiasm.
4. Hemostasis is required for hemorrhage from large arteries.
5. Treatment non hemorrhagic serious oozing surfaces, since body fluids, except whole blood, such as serum, do not react with Surgi ORC Haemostat to give satisfactory result.
6. Haemostat is required as adhesion prevention product.
7. Patients with known hypersensitivity of Cellulose.
8. Hemostasis is required in open blood vessel.
9. Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care), or is lactating.
10. Patient has an active infection at the surgical site.
11. Patient has known bleeding disorder (including thrombocytopenia [less than 100,000 platelet count], thrombobasthenia, haemophilia, or von Willebrand disease)
12. Patient has received antibiotic solutions or powders at the intended application site.
13. Patient is unavailable for follow-up.
14. Patient is currently participating in another clinical study.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Determination of Time to Heamostasis (TTH) Time Frame Day 0 Surgery-Proportion of wounds achieving hemostasis at every 2 minutes, 5 minutes and 10 minutes after the application of Surgi-ORC.   Pre-Operative, Operative Day 0, Day 2, Day 28, Day 60. 
 
Secondary Outcome  
Outcome  TimePoints 
1 Hemostatic Handling Characteristics Surgeons Questionnaire Time Frame Day 0 Surgery Determination of handling characteristics of Surgi-ORC during its implantation.
2 Liquefication of Surgi-ORC Time Frame Day 2 post-Procedure Determination of initiation of absorption of Surgi-ORC through radiological examination after 2 days of its implantation.
3 Complete Absorption of Surgi-ORC Time Frame Day 28 post-procedure Determination of complete absorption of oxidized regenerated cellulose through radiological examination after 28 days of its implantation.
4 Determination of Safety Time Frame Procedure up to 60 days post-procedure Evaluation of rate of complication adverse reaction due to the implantation of Surgi-ORC.  		 Pre-Operative, Operative Day 0, Day 2, Day 28, Day 60. 
 
Target Sample Size   Total Sample Size="107"
Sample Size from India="107" 
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/02/2024 
Date of Study Completion (India) 12/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="21" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  Clinical Study Report

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response (Others) -  For any type of Research

  5. By what mechanism will data be made available?
    Response (Others) -  at the CTRI Site

  6. For how long will this data be available start date provided 30-04-2024 and end date provided 29-06-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Study Design: Prospective, multi-center, single-arm, observational, post-market clinical follow-up registry study.

Study Population: Patients undergoing following surgeries:

Abdominal Surgery, Gynecological Surgery, Partial Nephrectomy, Anorectal Surgery, Hysterectomy, Plastic Surgery, Dental Surgery, Neuro Surgery, Cardiovascular Surgery, ENT surgery, Orthopedic Surgery, Spinal Surgery, Genito Urinary Surgery, Otolaryngological Surgery, Tumor Surgery, Hepatic Surgery, Ophthalmic Surgery, Cardiothoracic Surgery, General Surgery, Obstetrics Surgery, Urologic Surgery.

No. of Study Subject: 107

No. of Study Sites: Minimum 2 sites

Subject Device: Oxidized Regenerated Cellulose Haemostats:

1.     Surgi-ORC® Original / Standard,

2.      Surgi-ORC® Fibril,

3.      Surgi-ORC® Knit and

4.       Surgi-ORC® Non-woven/SNOW

5.        Surgi-ORC® Powde

Study Duration: 60 days

Study Schedule: Study schedule includes pre-operative evaluation, operative day (0 day) and four follow-ups.

The follow-up days will include 2nd day, 28th day, and 60th day after surgery

 
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