Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: PD Synth polydioxanone suture: PD Synth® Healthium suture
Control Intervention1: PDS polydioxanone suture: PDS® Johnson & Johnson suture
Sponsors
Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd
Eligibility
Inclusion criteria
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
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 =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate of incisional hernia with PD Synth (Healthium) and PDS (Ethicon, J & J) polydioxanone sutures, at 6 months and 12 months post-abdominal fascial closureTimepoint: 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the surgical site infection, fascial dehiscence and suture sinus 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 evaluate postoperative discomfort, pain and overall patient satisfaction score Timepoint: Day 3 Day 7 Month 1 Month 3 Month 6 Month 12 | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Pvt.Ltd. (formerly Sutures India Pvt. Ltd.)
Outcome results
None listed