A study comparing two different Non-Adherent Wound Dressing in Obstetric and Gynecological surgeries

A single blind, single centre, randomized, comparative study to assess the safety and effectiveness of Trushield NXT Non-Adherent Wound Dressing versus Tegaderm HPPad Film Dressing with Non-Adherent Pad in post-operative wound management of Obstetric and Gynecological surgeries

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/12/038884

Enrollment

102

Registered

2021-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Trushield NXT Non-Adherent Wound Dressing: Non-adherent Wound dressing which is applied on surgical wounds for upto 3 days after surgery Control Intervention1: Tegaderm HP Pad Film Dres

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. To evaluate post-operative wound complications 2. To evaluate scar cosmesis 3. To evaluate subject and surgeon satisfaction of the dressing 4. To evaluate wound pain and pain during dressing removal 5. To evaluate material problems and other adverse eventsTimepoint: Day 0, 3, 10 and 35	—

Countries

India

Contacts

Public ContactPrema DCunha

Father Muller Medical College

prema_dcunha@yahoo.com9845342488

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026