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RECRUITING
NCT06943053
NA

Evaluation of Ioband Coverage Waterproof Dressing Versus Isolated Waterproof Dressing After Primary Total Knee Arthroplasty

Sponsor: Thammasat University Hospital

View on ClinicalTrials.gov

Summary

Title: Evaluation of Ioband® Coverage Waterproof Dressing in Post-Operative Total Knee Arthroplasty (TKA) Goal: To evaluate the effectiveness of Ioband® coverage waterproof dressing compared to standard waterproof dressing in reducing dressing change frequency and peel-off degree post-op TKA. Main Research Questions: 1. Does Ioband® coverage waterproof dressing significantly decrease the degree of peel-off compared to standard waterproof dressing? 2. Does Ioband® coverage reduce the number of wound dressing changes required post-operatively? 3. Does Ioband® coverage improve overall patient satisfaction compared to standard waterproof dressing? Participants: Participants will include patients who have undergone total knee arthroplasty (TKA). Main Tasks and Interventions: 1. Randomization: Participants will be randomly assigned to receive either the Ioband® coverage waterproof dressing or the standard waterproof dressing. 2. Application of Dressings: Participants will have the assigned dressing applied to their surgical site post-operatively. 3. Assessment of Peel-Off Degree: Participants will undergo assessments to evaluate the degree of peel-off of the dressing over a specified time. 4. Wound Dressing Changes: Participants will have their dressing changed as per routine care protocols, with documentation of the number of changes. 5. Patient Satisfaction Survey: Participants will complete a satisfaction survey to assess their experiences with the dressing and overall comfort. Conclusion: The trial aims to provide insights into the benefits of Ioband® coverage waterproof dressing in improving post-operative care for TKA patients, focusing on key outcomes related to dressing performance and patient satisfaction.

Official title: Does Ioband Coverage Waterproof Dressing Provide Better Outcome Than Isolate Waterproof Dressing After Primary Total Knee Arthroplasty? A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2025-04-06

Completion Date

2026-04-16

Last Updated

2025-04-24

Healthy Volunteers

Yes

Interventions

DEVICE

Isolate waterproof dressing (Opsite)

Application of standard Opsite® waterproof dressing directly over the surgical incision following primary total knee arthroplasty. No additional drape or coverage was applied. The dressing remained in place until removal.

DEVICE

Ioban coverage group

Application of Ioban® iodine-impregnated antimicrobial incise drape over the standard waterproof dressing following primary total knee arthroplasty. The Ioban drape extends 2 cm beyond all edges of the dressing and remains in place until removal.

Locations (2)

Thammasat University Hospital

Pathum Thani, Khlong luang, Thailand

Department of Orthopaedics, Thammasat University

Pathum Thani, Thailand