Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Monoglyde�® Suture: Monofilament Poliglecaprone 25 sutures (Healthium) will be used for subcuticular closure of abdominal skin. This is an absorbable suture and will not be removed on
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 with good systemic/ mental health as per opinion of investigator 3. Women with CDC surgical wound classification class I 4. Women who have given written informed consent
Exclusion criteria
Exclusion criteria: 1. Women with BMI >27 Kg/m2 2. Women with hemoglobin levels 3. Women with a history of similar surgical procedure (suprapubic transverse scar, pfannensteil incision, laparoscopic procedure) 4. Women having urogenital tract infection within 2 weeks before cesarean delivery 5. Women in whom surgical plan is for a vertical skin incision 6. Women with history of allergy to the suture materials 7. Women with history of bleeding disorders 8. Women already participating in another trial 9. Women who received an experimental drug or used an experimental medical device within 3 months of becoming pregnant 10. Women unlikely to comply with the surgical procedure or complete the scheduled follow up visit, in the opinion of investigator 11. Other indication-based exclusion, in opinion of investigator
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate and compare the resultant scar and cosmetic effects of two sutures 2.To assess overall intraoperative handling between two sutures 3.To evaluate tissue reaction, material problems and other adverse events among the two groups 4.To compare bacterial accumulation/growth on the two suture materials 5.To assess the amount of time subject takes to resume back to normal activities in both the groups 6.To evaluate the postoperative subject satisfaction score in both the groupsTimepoint: Day 0 Day 3 Day 7 Month 1 and Month 4 | — |
Primary
| Measure | Time frame |
|---|---|
| To compare MonoglydeÃ?® (Healthium) and MonocrylÃ?® (Johnson & Johnson) subcuticular skin closure for wound composite outcome of one or more of the following: surgical site infection, wound dehiscence, hematoma, or seromaTimepoint: within the first 30 days postpartum | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Pvt. Ltd
Outcome results
None listed