Clinical trial on surgical wound closure in C-Sectio
- Conditions
- Health Condition 1: O900- Disruption of cesarean delivery wound
- Registration Number
- CTRI/2023/05/053000
- Lead Sponsor
- Jagdale industries pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Age: Reproductive Age Group
2.Gender: Pregnant Female Patients undergoing C- section
3.Should satisfy Indications of C-Section (Annexure)
4.Mentally Sound
5.Consents to be a part of the study
6.Patients without any local pathology or systemic diseases interfering with
7.or influencing haemorrhage, clotting or wound healing.
8.Patients with haemogram, bleeding time and clotting time within normal limits and without any bleeding and clotting disorder.
9.Patients with a fairly good general health (ASA I & II) without any contraindication for
10.C-Section and/or local anesthesia.
11.Agrees not to self-medicate or take any other therapies during the study.
1.Individuals who will not give written consent (wet-ink/electronic)
2.Known history of allergy or contraindications for Botroclot, its components
3.Patients with known premorbid conditions like, Hypertension, Diabetes Mellitus, GDM
4.Patients with mental illness.
5.Patients with conditions that affect blood coagulation- Hemophilia, Hypercoagulability,
6.Thromboembolic predisposition like deranged lipid profile, any bleeding disorder found
7.during screening.
8.Individuals on any other medications or nutritional supplements that may influence
9.Botroclot i.e. any other coagulant or anti-coagulant.
10.Patients undergoing any other form of delivery than C-Section
11.Patients with contraindications to spinal anesthesia or drugs used in the procedure.
12.Individuals not willing to follow protocol specified guidelines.
13.Subjects having any medical or surgical condition that would require immediate medical or
14.surgical intervention at the time of screening for this study or during the course of the study.
15.History of renal failure or dialysis, Hypercalcemia, Severe Liver Disease (Cirrhosis),
16.Sarcoidosis, or other Granulomatous Diseases (Wegener)
17.Previously diagnosed cases of immune-compromised status like HIV, Hepatitis B/C,
18.Tuberculosis, Cancer, etc. or deranged liver or kidney tests
19.Subjects taking or need to take systemic/oral steroid treatment and or any kind of
20.immunosuppressive therapy in the pre-study and during the study period
21.Subjects participating in any other clinical study or having participated in any other study
<1 month prior to screening in the present study
22.Other conditions, which in the opinion of the investigators, makes the subject unsuitable for
enrolment or could interfere with his participation in, and completion of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Bleeding Stoppage Time (BST)- From the time of administration of <br/ ><br>2.IP is observed by the Gynaecologist <br/ ><br>3.Bleeding time and Clotting time estimated before and after surgical wound closure in the group. Additionally, BT, CT before and after application of Botroclot in test group. <br/ ><br>4.Wound healing assessment [Time Frame: Up to 6 weeks after intervention] <br/ ><br>5.Scar Assessment scale by Vancouver scale. <br/ ><br>6.Gynaecological assessments are done. <br/ ><br>7.The number of patients who are diagnosed with surgical wound infection. <br/ ><br>8.Need for repeat Laparotomy [Time Frame: Up to 6 weeks after intervention] <br/ ><br>9.The number of patients who undergo a repeat laparotomy after the initial cesarean delivery will be ascertained. <br/ ><br>Timepoint: Day 0 to Day 42
- Secondary Outcome Measures
Name Time Method Safety <br/ ><br> Frequency of adverse events between the groupsTimepoint: Day 0 to Day 42