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CTRI Number  CTRI/2025/09/094145 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 01/11/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Two Types of Surgical Materials (Knitted and Fibrillar) to Control Bleeding in General and Gynaecological Surgeries 
Scientific Title of Study   A Prospective, Randomized Controlled Study to Evaluate the Safety and Effectiveness of Knitted and Fibrillar Forms of Oxidized Regenerated Cellulose for Haemostasis in General and Gynaecological Surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rathindranath Ray 
Designation  Assistant Professor 
Affiliation  IPGMER and SSKM Hospital 
Address  Department of Obstetrics & Gynaecology, Ronald Ross Building, 2nd Floor
244, AJC Bose Road, Kolkata 700020, West Bengal, India
Kolkata
WEST BENGAL
-700020
India 
Phone  6289344193  
Fax    
Email  rathindranathray1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rathindranath Ray 
Designation  Assistant Professor 
Affiliation  IPGMER and SSKM Hospital 
Address  Department of Obstretics and Gynaecology, Ronald Ross Building, 2nd Floor
244, AJC Bose Road, Kolkata 700020, West Bengal, India
Kolkata
WEST BENGAL
-700020
India 
Phone  6289344193  
Fax    
Email  rathindranathray1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rathindranath Ray 
Designation  Assistant Professor 
Affiliation  IPGMER and SSKM Hospital 
Address  Department of Obstetrics and Gynaecology, Ronald Ross Building 2nd Floor
244, AJC Bose Road, Kolkata 700020, West Bengal, India
Kolkata
WEST BENGAL
-700020
India 
Phone  6289344193  
Fax    
Email  rathindranathray1@gmail.com  
 
Source of Monetary or Material Support  
IPGMER and SSKM Hospital 244, AJC Bose Road Kolkata - 700020, West Bengal, India 
 
Primary Sponsor  
Name  IPGMER and SSKM Hospital 
Address  244, AJC Bose Road, Kolkata 700020, West Bengal, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sweta Singh  AIIMS Bhubaneswar  Department of Obstetrics & Gynaecology AIIMS Bhubaneswar Sijua, Patrapada, Bhubaneswar, Odisha 751019
Cuttack
ORISSA 
94388 84131
94388 84131
swetsingh@hotmail.com 
Dr Rathindranath Ray  IPGMER and SSKM Hospital  Department of Obstetrics and Gynaecology, Ronald Ross Building, 2nd floor, 244 AJC Bose Road, Kolkata 700020, West Bengal, India
Kolkata
WEST BENGAL 
6289344193

rathindranathray1@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences Bhubaneswar  Approved 
Research Oversight Committee IPGMER and SSKM Hospital  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 
Comparator Agent  Fibrillar ORC  Oxidized Regenerated Cellulose (ORC) has garnered extensive clinical use due to its biocompatibility, bio absorbability, bactericidal properties, and ease of application. It will be used only once during the surgical procedure to achieve haemostasis. 
Intervention  Knitted ORC  Oxidized Regenerated Cellulose (ORC) has garnered extensive clinical use due to its biocompatibility, bio absorbability, bactericidal properties, and ease of application. It will be used only once during the surgical procedure to achieve haemostasis 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1)
Age 18 to 70 years, male or female.
2)
Scheduled for elective general [Radical cholecystectomy, Splenectomy Anterior perineal resection (APR), Hepaticojejunostomy, Liver Resection, Cholecystectomy, Post-mastectomy bleeding and skin eczema management, Post-axillary dissection bleeding management] or gynecological surgery [Laparotomy in grade IV endometriosis, Ovarian staging Laparotomy (Cytoreductive surgery in a case of ovarian malignancy), Chronic Pelvic Inflammatory Disease (PID) with chronic Pelvic pain, or Myomectomy].
3)
ASA Physical Status I–III (American Society of Anesthesiologists classification).
4)
Willing and able to provide written informed consent.
5)
Hemodynamically stable preoperatively and not requiring emergency surgery. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to Hemostasis (proportion of patients achieving hemostasis within 3,5,10 mins of use of either Knitted and Fibrillar)  Randomization Visit (Visit 2) 
 
Secondary Outcome  
Outcome  TimePoints 
1.Total Perioperative Blood Loss (sum of intraoperative & postoperative losses within 24 hrs)
2.Operation Time (measured in minutes)
3.Change in Coagulation parameters (PT, aPTT, INR on Day 3)
4.Change in inflammatory response (postoperative WBC on Day 3)
5.Incidence of infection, re-bleeding hematoma, delayed healing, or allergic reaction
6.Incidence of AEs/SAEs
7.Length of Hospital Stay (days from surgery to discharge); incidence of readmission
8.Haemoglobin Drop (difference between preoperative & postoperative haemoglobin on Day 3)
9.Rate of Blood Transfusion (proportion of patients requiring transfusion)
10.Patient’s quality of Life questionnaire response preoperative & postoperative on Day of Discharge or Week 6)
11.Surgeon Satisfaction & Product Usability on Day 0 
Day3, Day of Discharge, Week 6, Week 12 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Hemorrhage control is especially challenging in procedures involving vascular-rich planes—such as the uterine bed during myomectomy or the liver parenchyma in hepatectomy—where brisk capillary, venous, or small arterial bleeding is difficult to manage using conventional methods alone. Techniques such as ligature, suturing, and electrocautery, while effective in many scenarios, may be either impractical or damaging in confined or delicate tissue environments. In such cases, hemostatic agents have become indispensable adjuncts. These agents not only reduce intraoperative blood loss but also help minimize reliance on systemic hemostatic or transfusion support, thereby enhancing patient safety and recovery. Among these, Oxidized Regenerated Cellulose (ORC) has garnered extensive clinical use due to its biocompatibility, bio absorbability, bactericidal properties, and ease of application. ORC functions through a physical mechanism: upon contact with blood, it swells to form a gelatinous matrix that facilitates platelet aggregation and clot formation. Simultaneously, its low pH (~3) environment creates a bactericidal effect, inhibiting the growth of common pathogens—a significant advantage in abdominal and pelvic surgeries, where contamination risk is often elevated due to proximity to the gastrointestinal or genitourinary tract. ORC product, is designed in multiple variants and commonly two structural variants—Knitted and Fibrillar—are used to suit different surgical needs. Knitted ORC is composed of interwoven fibres, giving it a firm, fabric-like structure that ensures mechanical strength and durability. This makes it particularly suitable for lining large surgical surfaces, reinforcing suture lines, or packing surgical cavities where tissue approximation is required and the material needs to maintain its shape under pressure. In contrast, Fibrillar ORC has a soft, pliable, and multi-layered texture that enables it to be easily torn, shaped, and moulded. It is highly conformable, allowing it to fill irregular anatomical spaces or adhere to complex surfaces—such as the uterosacral ligaments or paracolic gutters—making it ideal for laparoscopic and endoscopic procedures where access is limited.
Rationale: The rationale for this study stems from the growing need for effective, safe, and versatile hemostatic agents in surgical practice, particularly in general, abdominal, and gynecological procedures, where intraoperative bleeding poses significant clinical and economic burdens. Uncontrolled bleeding not only increases morbidity and transfusion requirements but also prolongs operative time, hospital stay, and overall healthcare costs. In complex anatomical sites or minimally invasive surgeries, traditional methods such as suturing or cautery may be impractical or insufficient, underscoring the need for reliable topical hemostatic solutions.
 
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