A study comparing two similar suture materials for closing a tissue layer below the skin, after cesarean delivery

Phase 4

Completed

• Conditions: Health Condition 1: - Health Condition 2: O80- Encounter for full-term uncomplicated delivery

• Registration Number: CTRI/2020/07/026824
• Lead Sponsor: Healthium Medtech Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-24
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 116

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

1. Women with hemoglobin levels <7g/dL

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified