Post marketing study to evaluate safety and efficacy of suture material (MITSUâ?¢ Polyglactin 910) of Meril Endo Surgery Pvt. Ltd in comparision with coated (Vicrylâ?¢ Polyglactin 910) Suture during surgery for closure of surgical incision.
- Conditions
- Health Condition 1: 8- Other Procedures
- Registration Number
- CTRI/2017/01/007717
- Lead Sponsor
- Meril EndoSurgery Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 122
1) Both male and female aged gteater than or equal to 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 closure of surgical incision where general soft tissue approximation and/or ligation is required
during elective surgery by using either MITSU Polyglactin 910 Suture of Meril Endo-Surgery Pvt. Ltd (study product) or Vicryl Polyglactin 910 Suture of Ethicon, Inc.(comparator) as per the discretion of principal investigator.
4) Subject agrees not to participate in any other investigational or invasive study for a period of 6 months.
5) Subject agrees to comply with all protocol requirements and protocol specific follow-up visits.
1) Subject with history of HIV or any other systemic infections.
2) Subject in any case requiring other emergency operations (major surgical procedure).
3) Subject with on-going sepsis or septicaemia or on-going bacterial infections or on antibiotic treatment (other than prophylaxis antibiotics given prior to and post surgery).
4) Subject with history of prior surgery in recent past (within 1 month) with surgical site infection.
5) Patient with positive Urine pregnancy test (using urine pregnancy test kits) other than patient require the gynaecological surgical procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall wound dehiscenceTimepoint: At post-procedure, <br/ ><br>14 days (±2 days), 30 days (±7 days) and 6 months (±28 <br/ ><br>days)
- Secondary Outcome Measures
Name Time Method ength of hospital stayTimepoint: Length of stay is calculated by subtracting day of admission from day of discharge.;Rate of Superficial Incisional Surgical Site Infection (SSI)Timepoint: At baseline, post procedure/discharge, 14 days (±2 days), 30 days (±7 days) and 6 months (±28 days)