Health Condition 1: 8- Other Procedures
Conditions
Interventions
Intervention1: MITSU ABâ?¢ Polyglactin 910 Suture: MITSU ABâ?¢ Polyglactin 910 Suture in the closure of surgical incision.
Control Intervention1: Vicrylâ?¢ Plus Antibacterial (Polyglactin 910) Suture:
Sponsors
Meril EndoSurgery Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Both male and female aged >=18 years old. 2)Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure. 3)Subjects scheduled for either orthopaedic surgical procedure or gynaecological surgical procedure. 4)Subject agrees not to participate in any other investigational or invasive study for a period of 12 months. 5)Subject agrees to return for scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1)Subject has a known allergy with triclosan. 2)Subject with history of HIV. 3)Subject in any case requiring other emergency operations. 4)Subject with on-going sepsis or septicaemia, on-going bacterial infections or antibiotic treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall wound dehiscenceTimepoint: At post-procedure, 14 days and 30 days (±14 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospital length of stayTimepoint: after the procedure.;Rate of Surgical Site Infection (SSI)Timepoint: At baseline, post procedure/discharge, 14 days (±14 days) and 30 days (±28 days), 6 months (±28 days) and 12 months (±28 days) | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Chief Gynecologist and Infertility Specialist- Dixit Hospital
Outcome results
None listed