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

NCT06943053 | Recruiting DMC

• 1 other identifier: TUH wound coverage after TKA
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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. 1.Does Ioband® coverage waterproof dressing significantly decrease the degree of peel-off compared to standard waterproof dressing?
2. 2.Does Ioband® coverage reduce the number of wound dressing changes required post-operatively?
3. 3.Does Ioband® coverage improve overall patient satisfaction compared to standard waterproof dressing?
4. 4.Randomization: Participants will be randomly assigned to receive either the Ioband® coverage waterproof dressing or the standard waterproof dressing.
5. 5.Application of Dressings: Participants will have the assigned dressing applied to their surgical site post-operatively.
6. 6.Assessment of Peel-Off Degree: Participants will undergo assessments to evaluate the degree of peel-off of the dressing over a specified time.
7. 7.Wound Dressing Changes: Participants will have their dressing changed as per routine care protocols, with documentation of the number of changes.
8. 8.Patient Satisfaction Survey: Participants will complete a satisfaction survey to assess their experiences with the dressing and overall comfort.

Conditions

Postoperative Wound Care After TKA

Keywords

total knee arthroplasty; Ioband® coverage waterproof dressing

Outcome Measures

Primary Outcomes (1)

• Number of change wound dressing

  Indication for changing wound dressing before appointment 1. Post op wound with waterproof peel off grade II (waterproof peel off to pad) or grade III (waterproof peel off involve into pad) 2. Waterproof has bloody more than 50 % 3. suspected Surgical site infection

  14 days postoperation

Secondary Outcomes (4)

• Degree of peel off wound

  14 days postoperation

• Satisfactory of patient

  14 days post-operation

• Post op Range of motion of knee

  At 2 weeks, 6 weeks and 3 months postoperation

• Wound-related Complication

  At 2 weeks, 6 weeks and 3 months postoperation

Study Arms (2)

Control Group: Isolated waterproof dressing (Opsite®).

ACTIVE COMPARATOR

Isolated waterproof dressing (Opsite®).

Device: Isolate waterproof dressing (Opsite)

Ioban Coverage group

EXPERIMENTAL

Participants in this group will receive an Ioban iodine-impregnated antimicrobial incise drape placed over the standard water proof dressing at the end of primary total knee arthroplasty.the ioban drape extends 2 cm beyond the edge of the primary dressing and remain in place until dressing remove

Device: Ioban coverage group

Interventions

Isolate waterproof dressing (Opsite) DEVICE

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.

Control Group: Isolated waterproof dressing (Opsite®).

Ioban coverage group DEVICE

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.

Ioban Coverage group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary unilateral TKA
• Age 55-80 yrs

You may not qualify if:

• Chronic Skin disease such as Psoriasis
• Chronic steroid use
• Allergy to skin adhesive, Cover wound
• Robotic TKA
• Iodine allergy
• Not follow protocol

Sponsors & Collaborators

• Thammasat University Hospital: lead

Study Sites (2)

Thammasat University Hospital

Pathum Thani, Khlong luang, 12120, Thailand

RECRUITING

Department of Orthopaedics, Thammasat University

Pathum Thani, 12120, Thailand

RECRUITING

Related Publications (1)

• 1 Primary Total Knee Replacement: A Recipe for Dry Dressing Azfar KM, Adil AO, Tarig AR, Adel G. Primary Total Knee Replacement: A Recipe for Dry Dressing. Cureus. 2023;15(4). 2 The effect of different wound dressing materials used in postoperative treatment of wounds after total hip arthroplasty and total knee arthroplasty: A meta-analysis Yingjia Yuan, Jin Li, Ke Wang, Guanqiang Zheng, Shengting Chai. The effect of different wound dressing materials used in postoperative treatment of wounds after total hip arthroplasty and total knee arthroplasty: A meta-analysis.IWJ. : April 2022. 3 Clinical outcome of different skin closure in TKA Chen L, Yang J, Xie J, Hu Y, Zeng M. Clinical outcome of different skin closure in total-knee arthroplasty: running subcuticular closure vs intermittent closure: a retrospective study. Medicine. 2020 Aug 8;99(34). 4 Closure in knee replacement surgery Kharat K. Closure in knee replacement surgery. Journal of Orthopaedic Case Reports. 2012 Jul;2(3):31. 5 Multilayer watertight closure to address adverse event from primary total knee and hip arthroplasty Snyder MA, Chen BP, Hogan A, Wright GW. Multilayer watertight closure to address adverse events from primary total knee and hip arthroplasty: a systematic review of wound closure methods by tissue layer. Arthroplasty today. 2021 Aug 1;10:180-9. 6 Persistent wound drainage after total joint arthroplasty: a narrative review Wagenaar FC, Löwik CA, Zahar A, Jutte PC, Gehrke T, Parvizi J. Persistent wound drainage after total joint arthroplasty: a narrative review. The Journal of Arthroplasty. 2019 Jan 1;34(1):175-82. 7 Effect of the knee position during wound closure after TKA on early knee function recovery. Wang S, Xia J, Wei Y, Wu J, Huang G. Effect of the knee position during wound closure after total knee arthroplasty on early knee function recovery. Journal of Orthopaedic Surgery and Research. 2014 Dec;9(1):1-6

  BACKGROUND

Study Officials

• Chanon Thassanaleelaporn, M.D.

  Thammasat University Hospital Thailand

  PRINCIPAL INVESTIGATOR

• Krit Boontanapibul, M.D.

  Thammasat University Hospital

  STUDY DIRECTOR

Central Study Contacts

Krit Boontanapibul, M.D.

CONTACT

66613957799; krit.boontanapibul@gmail.com

Chanon Thassanaleelaporn, M.D.

CONTACT

C.pond21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Krit Boontanapibul

Model Details: Title: Evaluation of Ioband Coverage Waterproof Dressing Versus Isolated Waterproof Dressing After Primary Total Knee Arthroplasty Objective: -To compare the effectiveness of Ioband coverage waterproof dressing against traditional isolated waterproof dressing in terms of dressing performance, patient satisfaction, and wound management after primary total knee arthroplasty. Participants: * Total of 96 patients undergoing primary TKA. * Randomly assigned to two groups of 48 patients each: * Intervention Group: Ioband coverage waterproof dressing. * Control Group: Isolated waterproof dressing (Opsite®). Randomization Method: \- Computerized block randomization conducted by an independent research assistant to ensure unbiased group allocation. Pre-operative protocol, surgical technique, post-operative pain control are the same

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 24, 2025
• Study Start: April 6, 2025
• Primary Completion: April 6, 2026
• Study Completion: April 16, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)