Clinical equivalence study of two polydioxanone sutures (PD Synth and PDS) for abdominal fascial closure following midline laparotomy

Phase 4

Completed

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2020/04/024955
• Lead Sponsor: Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

1. Subjects undergoing elective/emergency midline laparotomy

2. Male or female 18 to 60 years of age, with good systemic/ mental health as per opinion of investigator

3. Subjects with CDC surgical wound classification class I/II/III

4. Subjects who have given written informed consent

Exclusion Criteria

1. ASA-V classified Subjects

2. Subjects who are pregnant or planning pregnancy in next one year

3. Subjects having life expectancy of less than one year duration

4. Subjects with BMI <18.5 and >=30

5. Subjects with history of midline laparotomy

6. Subjects undergoing elective/emergency laparoscopic abdominal surgeries

7. Subjects requiring an early (within 30 days) reintervention after index surgery

8. Subjects having active infection at or around the skin incision site

9. Subjects having a history of or presenting with an abdominal hernia

10. Subjects having abdominal wall metastases

11. Subjects needing prophylactic mesh augmentation after midline laparotomy

12. Subjects with history of allergy to polydioxanone or similar products

13. Subjects with history of systemic diseases such as COPD, tuberculosis, bleeding disorders.

14. Subjects who had the habit of drug abuse

15. Subjects already participating in another trial

16. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure

17. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator

18. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center

19. Other indication-based exclusion, in the opinion of investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified