MedTrace Logo

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

NCT06943053 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-04-24

No results posted yet for this study

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.

Conditions

  • Postoperative Wound Care After TKA

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.

Sponsors & Collaborators

  • Thammasat University Hospital

    lead OTHER

Principal Investigators

  • Chanon Thassanaleelaporn, M.D. · Thammasat University Hospital Thailand

  • Krit Boontanapibul, M.D. · Thammasat University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-06
Primary Completion
2026-04-06
Completion
2026-04-16

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06943053 on ClinicalTrials.gov