A study comparing two brands of similar suture materials (Trulon�® and Ethilon�® polyamide suture), for closure of the skin following open abdominal surgeries
- Conditions
- Health Condition 1: O80- Encounter for full-term uncomplicated deliveryHealth Condition 2: N859- Noninflammatory disorder of uterus, unspecified
- Registration Number
- CTRI/2020/09/027978
- Lead Sponsor
- Healthium Medtech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 104
1. Women aged 18 to 50 years, undergoing laparotomy-based obstetric/ gynecological procedures
2. Women with CDC surgical wound classification class I/II
3. Women with good systemic/ mental health as per opinion of investigator
4. Subjects who have given written informed consent
1. Women with BMI >30 Kg/m2
2. Women with hemoglobin levels <7g/dL
3. Women with a history of any laparotomy procedure or laparoscopic surgery
4. Women having urogenital tract infection within 2 weeks before the procedure
5. Women needing prophylactic mesh augmentation after laparotomy
6. Women undergoing elective/emergency laparoscopic abdominal surgeries
7. Women having active infection at or around the skin incision site
8. Women with history of allergy to nylon or similar products
9. Women already participating in another trial
10. Women unlikely to comply with the surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
11. Other indication-based exclusion, in opinion of investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To compare the rate of wound infection with Trulon (Healthium) and Ethilon (J & J) polyamide suturesTimepoint: Day 3, Day 7-14, Week 6 and Week 12
- Secondary Outcome Measures
Name Time Method 1. To evaluate tissue reaction, wound dehiscence, skin disruptions, suture sinus, seroma, and hematoma <br/ ><br>2. To assess overall intraoperative handling between two sutures <br/ ><br>3. To assess the amount of time subject takes to return back to normal day to day activities <br/ ><br>4. To evaluate material problems and other adverse events <br/ ><br>5. To evaluate postoperative discomfort, pain and overall subject satisfaction score <br/ ><br>6. To evaluate and compare the resultant scar and cosmetic effects of two suturesTimepoint: Day 3, Day 7-14, Week 6 and Week 12