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

A randomized single blinded study to compare the safety and effectiveness of Trushield NXT Non-Adherent Wound Dressing over standard of care dressing in post-operative wound management of Obstetric and Gynecological surgeries

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/12/038800

Enrollment

114

Registered

2021-12-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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

Conditions

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

Interventions

Intervention1: Trushield NXT Non adherent wound dressing: 3-D Spacer fabric made of Polyethylene Terephthalate (90% w/w) & Polyurethane (10% w/w) + 1% w/w of DTAC

Dimethyl Tetradecyl [3-(trimethoxysilyl) propyl] ammonium chloride (Non-Leaching, permanently bound) Control Intervention1: Standard of Care: Cotton+ Povidone iodine+ Leukoplast

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Rathindranath Ray

IPGMER SSKM HOSPITAL

rathindra24@yahoo.com

Outcome results

None listed

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