FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073798 [Registered on: 11/09/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   A PMS Study to Evaluate Safety&Efficacy of Sterile Oxidized Regenerated Cellulose Hemostat(ORCH),By The Brand Names OxidoRCEL,XEALANTA,clotoRCEL & COAGULO-Rx for Bleeding Control During Elective Intraoperative Procedures & Traumatic Bleeding situations 
Scientific Title of Study   A Single-Center, Prospective, Open label, Single Arm, Post market Surveillance Study to Evaluate the Safety & Efficacy of Sterile Oxidized Regenerated Cellulose Hemostat (ORCH), Represented By The Brand Names OxidoRCEL, XEALANTA, clotoRCEL and COAGULO-Rx for Bleeding Control During Elective Intraoperative Procedures & Traumatic Bleeding situations  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
IMD-ORC-001-24 version 01 20 May 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J Sridhar 
Designation  Head of the Department of General Surgery  
Affiliation  Vinayaka Mission’s Kirupananda Variyar Medical College & Hospital  
Address  Vinayaka Mission’s Kirupananda Variyar MedicalCollege & Hospital, Department of GeneralSurgery, Ground Floor, RoomNo: 04,Sankari MainRoad(NH47),Seeragapadi,Ariyanoor, Salem-636308,Tamil Nadu,India.

Salem
TAMIL NADU
636308
India 
Phone  9362104518  
Fax    
Email  director.clinicaltrials@vmu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Mavila 
Designation  Managing Director 
Affiliation  inDerma Medical Devices 
Address  inDerma Medical Devices, Plot 14 D1-2/267 Rajaji Nagar Nallur SIPCOT Phase I Hosur India.

Chennai
TAMIL NADU
635126
India 
Phone  9313711234  
Fax    
Email  dranilmavila@gmail.com  
 
Details of Contact Person
Public Query  
Name  DT Arasu  
Designation  Director 
Affiliation  iDD Research Solutions Pvt.Ltd 
Address  iDD Research Solutions Pvt.Ltd Plot no:1&2, Kirti Nagar, Sector 15, Main Jharsa Road, Gurgaon, Haryana-122001,India.

Gurgaon
HARYANA
122001
India 
Phone  9962050483  
Fax    
Email  dtarasu@iddresearch.com  
 
Source of Monetary or Material Support  
inDerma Medical Devices Plot No- #14, 2/267,Nallur, Rajaji Nagar, SIPCOT Phase 1, Hosur- 635126, INDIA  
 
Primary Sponsor  
Name  inDerma Medical Devices 
Address  inDerma Medical Devices, Plot No-#14,2/267,Nallur, Rajaji Nagar,SIPCOT Phase 1, Hosur- 635126, INDIA  
Type of Sponsor  Other [Research and Manufacturing company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr J Sridhar  Vinayaka Mission’s Kirupananda Variyar Medical College & Hospital  Vinayaka Mission’s Kirupananda Variyar Medical College & Hospital Department of General Surgery, Ground Floor, Room No. 04 Sankari Main Road(NH-47),Seeragapadi, Ariyanoor, Salem, Tamil Nadu 636308
Salem
TAMIL NADU 		 0427-2529700

director.clinicaltrials@vmu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vinayaka Mission’s Kirupananda Variyar Medical College  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  Not Applicable  Not Applicable 
Intervention  Sterile Oxidized Regenerated Cellulose Hemostat (ORCH)  Sterile Oxidized Regenerated Cellulose Hemostat (ORCH) for Bleeding Control During Elective Intraoperative Procedures & Traumatic Bleeding situations 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  1. Male/females of 18 years of age or older
2. Patient who can and willing to provide written
Informed Consent
3. Patients with life expectancy of at least one
year

Intra-Operative inclusion criteria
1. Patients with mild or moderate bleeding/oozing during elective surgical procedures where
control of bleeding is difficult/ ineffective with conventional procedures.
2. Absence of intra-operative complications other than bleeding which, in the opinion of the
investigator, may interfere with the assessment of efficacy or safety
3. No active or suspected infection at the pre-defined surgical site/area
4. No intra-operative use of a topical hemostat containing thrombin
5. Approximate Target Bleeding Site of no more than 15cm length 
 
ExclusionCriteria 
Details  1.Patient having a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
2. Patient has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration
3. Patient with any type of coagulation disorders including thrombocytopenia that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator
4. Patient having has a clinically significant coagulation disorder or disease, platelets less than 10 multiplied by 10 to the power of 9 per L during screening
5. Patient with activated partial thromboplastin time (aPTT) greater than 100 seconds during screening
6. Patient with International Normalized Ratio (INR)greater than 2.5 during screening
7. Patient receiving antiplatelet medications within 5 days prior to surgery
8. Patient has a documented severe congenital or acquired Immunodeficiency 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Number of participants with Adverse events
2. Absence of immediate surgical site swelling/ inflammation
3. Absence of vessel rupture and concurrent increase in bleeding
4. Absence of increase in bleeding levels without vessel rupture
5. Absence of additional bleeding (proximal to the original bleeding site/ within the
surgical field) 		 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean Time to Hemostasis
Time to achieve hemostats is will be recorded in minutes from the first application of study treatment until cessation of bleeding
2. Number of Patients achieved hemostasis without any subsequent follow up bleeding during the procedure from the site of application
3.Overall Investigator’s satisfaction scale for Sterile Oxidized Regenerated Cellulose Hemostat (ORCH) represented by brand names as indicated above at the end of the treatment in terms of ease of application & handling. 		 1 week 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   23/09/2024 
Date of Study Completion (India) 23/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
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 - NO
Brief Summary   Blood is a fluid that transports oxygen and nutrients to the cells and carries away carbon dioxide and other waste products. Technically, blood is a transport liquid pumped by the heart (or an equivalent structure) to all parts of the body, after which it is returned to the heart to repeat the process. Blood is an opaque red fluid, freely flowing but denser and more viscous than water.

Thrombocytes are also called platelets and are cell fragments which circulate within the blood with a life span of about 10 days. Platelets are anucleate disk-shaped cells, 2–4 μm in diameter. The normal platelet count is 150,000–400,000 per cubic millimeter or 150–400 × 109 platelets per liter.
Hemostasis:
Hemostasis is the process by which the body seals a ruptured blood vessel and prevents further loss of blood. 
Hemostasis or bleeding control during elective & traumatic surgical procedures is essentially aimed at controlling vascular leakage with the support of pro-hemostatic agents, tools or methods in order to preserve the blood as well as to create a visually clear operating field for further downstream “procedures or for the closure of surgical site”. An effective hemostatic agent or tool essentially prevents the bleeding within the stipulated time and on further application prevents minor capillary oozing or leakage that may happen during downstream procedures or during recovery period. Oxidized Regenerated Cellulose Hemostat is an effective bleeding control agent and is recommended when other conventional bleeding control agents are either ineffective or difficult to apply.

RATIONALE FOR CONDUCTING THIS STUDY
Sterile Oxidized Regenerated Cellulose Hemostat has traditionally been used for surgical bleeding control where application of conventional bleeding control procedures including electro cauterization or other ligature techniques is impractical or not effective due to specific anatomic and physiological reasons.
Oxidized regenerated cellulose hemostats represent an important class of biocompatible and bioabsorbable polymers, and they have been available in a sterilized knitted fabric, non-woven fluffy or powder form for surgical hemostasis. Oxidized regenerated cellulose hemostat is a white or pale yellow in color and can be cut into desired sizes for different surgeries. It is useful for all types of surgeries where intra-operative bleeding is anticipated or encountered such as procedures in General& Colorectal surgery, Gynecology & genitourinary surgeries, Orthopedic surgery, Oncological surgery, Colon surgery, Neurosurgery and CVTS etc., to name a few. Oxidized regenerated cellulose is an absorbable hemostat and is fully resorbable from the site of application within stipulated time.
 
Close