Health Condition 1: O754- Other complications of obstetric surgery and procedures
Conditions
Interventions
Intervention1: Trusynth Plus Neo suture: Triclosan-Coated Polyglactin 910 Suture
Manufactured by Healthium Medtech Limited. Once implanted, the suture will not be removed from body.
Control Intervention1: Vicryl Plus Suture: Triclosan-Coated Polyglactin 910 Suture
Manufactured by Ethicon, Johnson and Johnson. Once implanted, the suture will not be removed from body.
Sponsors
Healthium Medtech Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 18 to 40 years scheduled to undergo caesarean section delivery using a Pfannenstiel incision 2. Pregnant women who have given written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant women with haemoglobin levels less than 7g/dL 2. Pregnant women with active systemic infection or sepsis, or receiving therapeutic antibiotics other than standard perioperative prophylaxis 3. Pregnant women with known HIV infection 4. Pregnant women with a known allergy or hypersensitivity to triclosan and/or polyglactin 910 sutures 5. Pregnant women requiring additional major surgical procedures at the time of caesarean section 6. Pregnant women receiving chronic systemic corticosteroids, immunosuppressive therapy, or other medications known to impair wound healing 7. Pregnant women with known bleeding or coagulation disorders 8. Pregnant women diagnosed with placenta accreta spectrum (PAS) disorders 9. Pregnant women with intrauterine foetal demise (stillbirth) 10. Pregnant women who, in the opinion of the investigator, are unlikely to comply with the study procedures or complete scheduled follow-up visits 11. Any condition which, in the opinion of the investigator, may compromise trial participant s safety or affect study integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the clinical equivalence between Trusynth Plus Neo and Vicryl Plus sutures in caesarean section wound closure, as assessed by the change in ASEPSIS wound score from Day 3 post-surgery (Day 3 1 day) to Day 30 post-surgery (Day 30 7 days)Timepoint: Visit 3 (Day 3 1), Visit 5 (Day 30 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare postoperative wound condition between Trusynth Plus Neo and Vicryl Plus sutures following caesarean section, as assessed by the change in ASEPSIS wound score from Day 3 post-surgery (Day 3 1 day) to Day 14 ( 3 days), Day 30 ( 7 days), and Day 90 ( 7 days) post-surgeryTimepoint: Visit 3 (Day 3 1), Visit 4 (Day 14 3), Visit 5 (Day 30 7), Visit 6 (Day 90 7);To compare the operative time between Trusynth Plus Neo and Vicryl Plus suture groupsTimepoint: Visit 2 (Day of Surgery);To compare the intra-operative suture handling and needle characteristics between Trusynth Plus Neo and Vicryl Plus suture groupsTimepoint: Visit 2 (Day of Surgery);To compare the intra-operative complications between Trusynth Plus Neo and Vicryl Plus suture groupsTimepoint: Visit 2 (Day of Surgery);To compare the incidence of post-operative complications, including surgical site infection and other wound-related complications, between Trusynth Plus Neo and Vicryl Plus suture groupsTimepoint: Visit 3 (Day 3 1), Visit 4 (Day 14 3), Visit 5 (Day 30 7), Visit 6 (Day 90 7);To compare the length of hospital stay between Trusynth Plus Neo and Vicryl Plus suture groupsTimepoint: Visit 4 (to collect the date of discharge);To compare the postoperative pain intensity between Trusynth Plus Neo and Vicryl Plus suture groupsTimepoint: Visit 3 (Day 3 1), Visit 4 (Day 14 3), Visit 5 (Day 30 7), Visit 6 (Day 90 7);To compare postoperative activities of daily living between the Trusynth Plus Neo and Vicryl Plus suture groupsTimepoint: Visit 3 (Day 3 1), Visit 4 (Day 14 3), Visit 5 (Day 30 7), Visit 6 (Day 90 7);To compare the incidence of residual risks, adverse events (AEs) and serious adverse events (SAEs) between Trusynth Plus Neo and Vicryl Plus suture groupsTimepoint: Visit 2 (Day of surgery), Visit 3 (Day 3 1), Visit 4 (Day 14 3), Visit 5 (Day 30 7), Visit 6 (Day 90 7);To compare the cosmetic appearance of the resultant surgical scar following caesarean section between | — |
Countries
India
Contacts
Public ContactDr Ashok Moharana
Healthium Medtech Ltd
Outcome results
None listed