A Study Comparing Two Types of Surgical Materials (Knitted and Fibrillar) to Control Bleeding in General and Gynaecological Surgeries

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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/09/094145

Enrollment

108

Registered

2025-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Knitted ORC: Oxidized Regenerated Cellulose (ORC) has garnered extensive clinical use due to its biocompatibility, bio absorbability, bactericidal properties, and ease of application. I

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Time to Hemostasis (proportion of patients achieving hemostasis within 3,5,10 mins of use of either Knitted and Fibrillar)Timepoint: Randomization Visit (Visit 2)	—

Secondary

Measure	Time frame
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 0Timepoint: Day3, Day of Discharge, Week 6, Week 12	—

Measure

Time frame

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 0Timepoint: Day3, Day of Discharge, Week 6, Week 12

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Countries

India

Contacts

Public ContactDr Rathindranath Ray

IPGMER and SSKM Hospital

rathindranathray1@gmail.com6289344193

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026