| 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
|
|
|
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
|
|
|
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 |
|
|
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. |