CTRI/2020/09/027978
Completed
Phase 4
Single blind, randomized study comparing clinical equivalence of Trulon�® and Ethilon�® polyamide sutures, for closure of the skin following laparotomy incisions
Healthium Medtech Pvt Ltd0 sites104 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: O80- Encounter for full-term uncomplicated deliveryHealth Condition 2: N859- Noninflammatory disorder of uterus, unspecified
- Sponsor
- Healthium Medtech Pvt Ltd
- Enrollment
- 104
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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