A study comparing two different Non-Adherent Wound Dressing in Obstetric and Gynecological surgeries
- Conditions
- Health Condition 1: O82- Encounter for cesarean delivery without indication
- Registration Number
- CTRI/2021/12/038884
- Lead Sponsor
- Father Muller Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Women of age 18 â?? 65 years
2. Subject undergoing uncomplicated open obstetric/gynecological surgery in the opinion of the investigator
3. Subject with Hb >= 9gm/dl
4. Subject ready to give written consent for the study
1. Subject with condition/comorbidity that could compromise wound healing, including eczema, peripheral vascular disease, receiving immunosuppressive, high dose corticosteroid medications, corticosteroid abuse, and having uncontrolled diabetes
2. Subject with a systemic infection not controlled by suitable antibiotic treatment
3. Subject with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant agents
4. Subject participating in another clinical study less than 30 days before participation in this study
5. Investigatorâ??s discretion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess effectiveness of Trushield NXT Non adherent wound dressing Versus Tegaderm HP+Pad Film Dressing with Non-Adherent Pad in post-operative wound management of obstetric and gynecological surgeriesTimepoint: Day 0, 3, 10 and 35
- Secondary Outcome Measures
Name Time Method 1. To evaluate post-operative wound complications <br/ ><br>2. To evaluate scar cosmesis <br/ ><br>3. To evaluate subject and surgeon satisfaction of the dressing <br/ ><br>4. To evaluate wound pain and pain during dressing removal <br/ ><br>5. To evaluate material problems and other adverse eventsTimepoint: Day 0, 3, 10 and 35