Health Condition 1: O900- Disruption of cesarean delivery wound
Conditions
Interventions
Intervention1: Haemocoagulase Solution 0.2 CU (BotroClot): 1. Dose :0.2 CU/ml
2. Frequency: once a day 5 to 10 drops
3. Route of administration: Topical
4. Duration of therapy: 11 days
Control Inte
Sponsors
Jagdale industries pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Bleeding Stoppage Time (BST)- From the time of administration of 2.IP is observed by the Gynaecologist 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. 4.Wound healing assessment [Time Frame: Up to 6 weeks after intervention] 5.Scar Assessment scale by Vancouver scale. 6.Gynaecological assessments are done. 7.The number of patients who are diagnosed with surgical wound infection. 8.Need for repeat Laparotomy [Time Frame: Up to 6 weeks after intervention] 9.The number of patients who undergo a repeat laparotomy after the initial cesarean delivery will be ascertained. Timepoint: Day 0 to Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Frequency of adverse events between the groupsTimepoint: Day 0 to Day 42 | — |
Countries
India
Contacts
Public ContactMr Raghavendra K V
Radiant Research Services Pvt. Ltd
Outcome results
None listed