CTRI/2020/07/026824
Completed
Phase 4
Single blind randomized comparative study comparing clinical equivalence of two polyglactin 910 suture brands, Trusynth�® and Vicryl�®, for subcutaneous tissue closure after cesarean delivery
Healthium Medtech Pvt Ltd0 sites116 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: - Health Condition 2: O80- Encounter for full-term uncomplicated delivery
- Sponsor
- Healthium Medtech Pvt Ltd
- Enrollment
- 116
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Primiparous or multiparous women aged 18\-40 years with a singleton pregnancy
- •2\. Women undergoing caesarean section by Pfannenstiel incision
- •3\. Women with good systemic/ mental health as per opinion of investigator
- •4\. Women with CDC surgical wound classification class I
- •5\. Women who have given written informed consent
Exclusion Criteria
- •1\. Women with hemoglobin levels \<7g/dL
- •2\. Women who donââ?¬•t require subcutaneous suturing
- •3\. Women with a history of similar surgical procedure (suprapubic transverse scar, pfannensteil incision, laparoscopic procedure)
- •4\. Women having urogenital tract infection or chorioamnionitis within 2 weeks before cesarean delivery
- •5\. Women who will have a stillbirth
- •6\. Women in whom surgical plan is for a vertical skin incision
- •7\. Women with history of allergy to the suture materials
- •8\. Women with history of bleeding disorders
- •9\. Women already participating in another trial
- •10\. Women who received an experimental drug or used an experimental medical device within 3 months of becoming pregnant
Outcomes
Primary Outcomes
Not specified
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