Health Condition 1: - Health Condition 2: O80- Encounter for full-term uncomplicated delivery
Conditions
Interventions
Intervention1: Trusynth Suture�®: Trusynth Suture (Healthium) (Polyglactin 910 absorbable suture
Suture will be used for subcutaneous tissue closure and will not be removed once it is applied)
Control Intervention1: Vicryl Suture�®: Vicryl Suture (Johnson & Johnson) (Polyglactin 910 absorbable
Sponsors
Healthium Medtech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Primiparous or multiparous women aged 18-40 years with a singleton pregnancy 2. Women undergoing caesarean section by Pfannenstiel incision 3. Women with good systemic/ mental health as per opinion of investigator 4. Women with CDC surgical wound classification class I 5. Women who have given written informed consent
Exclusion criteria
Exclusion criteria: 1. Women with hemoglobin levels 2. Women who donââ?¬•t require subcutaneous suturing 3. Women with a history of similar surgical procedure (suprapubic transverse scar, pfannensteil incision, laparoscopic procedure) 4. Women having urogenital tract infection or chorioamnionitis within 2 weeks before cesarean delivery 5. Women who will have a stillbirth 6. Women in whom surgical plan is for a vertical skin incision 7. Women with history of allergy to the suture materials 8. Women with history of bleeding disorders 9. Women already participating in another trial 10. Women who received an experimental drug or used an experimental medical device within 3 months of becoming pregnant 11. Women unlikely to comply with the surgical procedure or complete the scheduled follow up visit, in the opinion of investigator 12. Other indication-based exclusion, in opinion of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare TrusynthÃ?® (Healthium) and VicrylÃ?®(Johnson and Johnson) polyglactin 910 suture for subcutaneous abdominal wound disruptions within the first 6 weeks of cesarean deliveryTimepoint: Within 6 weeks of cesarean delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare subcutaneous abdominal wound disruptions within the study period 2. To evaluate tissue reaction, SSI, seroma, and hematoma among the two groups 3. To assess overall intraoperative handling between two sutures 4. To assess the amount of time subject takes to return back to normal activities in both the groups 5. To evaluate material problems and other adverse events among the two groups 6. To compare bacterial accumulation/growth on the two suture materialsTimepoint: Day 3, Day 4-7, Week 6 and Week 12 | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Pvt.Ltd.,
Outcome results
None listed