Post marketing study to Evaluate safety and efficacy of Suture material (MITSU ABâ?¢ Polyglactin 910) of Meril Endo Surgery Pvt. Ltd in comparision with coated Vicrylâ?¢ Plus Antibacterial (Polyglactin 910) Suture during surgery for closure of surgical incision.
Not Applicable
Completed
- Conditions
- Health Condition 1: 8- Other Procedures
- Registration Number
- CTRI/2017/01/007736
- Lead Sponsor
- Meril EndoSurgery Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 122
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall wound dehiscenceTimepoint: At post-procedure, 14 days and 30 days (±14 days)
- Secondary Outcome Measures
Name Time Method 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)