A study to compare a Non-Adherent Wound Dressing with a normally used cotton dressing after Obstetric and Gynecological surgeries

Phase 4

Completed

• Conditions: Health Condition 1: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system

• Registration Number: CTRI/2021/12/038800
• Lead Sponsor: IPGMER and SSKM Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Women of 18 â?? 65 years

2.Uncomplicated obstetric & gynecological surgeries in the opinion of the investigator

3.Hb >= 7gm/dl

4. Ready to give consent for the study

Exclusion Criteria

1. Patients with condition/comorbidity that could compromise wound healing, including varicose eczema, peripheral vascular disease, receiving immunosuppressive medications, corticosteroid abuse, and having uncontrolled diabetes.

2. Patients with a systemic infection not controlled by suitable antibiotic treatment

3. Patients with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant agents

4. Patients treated for a chronic disease requiring high doses of systemic corticosteroids (>= 40 mg/dl of prednisolone or equivalent)

5. Patients with a severe illness that might lead to premature withdrawal from the trial

6. Patients participating in another clinical trial less than 30 days before participation in this trial

7. Investigatorâ??s discretion

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of Trushield NXT Non adherent wound dressing over standard of care dressing in post-operative wound management of obstetric and gynecological surgeriesTimepoint: Day 3±1, 8±1, 42±7

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the pain scores via visual analog scale as well as the comfort and ease via product usage assessment scale <br/ ><br>2. To assess the cosmetic appearance of the wound using modified Hollander wound score scale <br/ ><br>3. To evaluate wound healing using photographs <br/ ><br>4. To evaluate patient satisfaction on wound dressing and wound healing <br/ ><br>5. To evaluate material problems and other adverse eventsTimepoint: Day 3±1, 8±1, 42±7