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Postoperative Wound Care After TKAWound coverageNCT06943053

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

A study testing Isolate waterproof dressing (Opsite) and Ioban coverage group in people with Postoperative Wound Care After TKA, run by Thammasat University Hospital at 2 sites in Thailand.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Postoperative Wound Care After TKA
What is being tested?
Isolate waterproof dressing (Opsite) and Ioban coverage group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
2 sitesThailand
Study dates
6 Apr 2025to 16 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Primary unilateral TKA
  • Age 55-80 yrs

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Krit Boontanapibul, M.D. contact

66613957799

krit.boontanapibul@gmail.com

Chanon Thassanaleelaporn, M.D. contact

C.pond21@gmail.com

Thailand2 sites, 2 recruiting
  • Thammasat University Hospital

    Pathum Thani, Khlong luang, 12120

    Chanon Thassanaleelaporn Thassanaleelaporn, M.D., 66896573218, C.pond21@hotmail.com

    Krit Boontanapibul Boontanapibul, M.D., 66613957799, krit.boontanapibul@gmail.com

    Recruiting
  • Department of Orthopaedics, Thammasat University

    Pathum Thani, 12120

    Krit Boontanapibul, M.D., 66613957799, krit.boontanapibul@gmail.com

    Recruiting

Other trials in Thailand

About this study

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

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.

Read more

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.

Read the detailed description

Study Design:

  • Participants: 96 patients undergoing TKA, randomly assigned to two groups of 48 each:
  • Intervention Group: Ioband® coverage waterproof dressing
  • Control Group: Standard waterproof dressing (Opsite®)

Randomization Method:

-Computerized block randomization performed by an independent research assistant.

Pre-operative Procedures:

  • Pre-emptive Analgesia administered 1 hour before surgery included:
  1. Naproxen (250 mg)
  2. Omeprazole (20 mg)
  3. Acetaminophen (500 mg)
  4. Pregabalin (75 mg) Anesthesia: Administered spinal anesthesia and ultrasound-guided adductor canal block by experienced anesthesiologists. Surgical Preparation:
  • Incision sites were prepped and draped using sterile technique.
  • Antiseptic Ioband® (60×45 cm) covered the incision site to prevent contamination.

Surgical Technique:

  • Utilization of a standard medial parapatellar approach with a minimally invasive TKA technique.
  • A tourniquet was inflated to 100 mmHg above systolic blood pressure and was deflated after wound closure.
  • Cemented posterior stabilizer prosthetics (Nexgen LPS) and patellar resurfacing were used.
  • Anesthetic cocktail (0.5% bupivacaine, adrenaline, ketorolac, morphine) was injected around the capsule after prosthesis insertion.

Post-operative Care:

  • No suction drains or extremity wraps used.
  • Wounds closed with waterproof dressing (Opsite® size 25×10 cm) in 90-degree knee flexion without tension.
  • Pain Management: Multimodal pain control was employed.
  • Antibiotic Prophylaxis: Administered for 24 hours post-surgery.
  • Rehabilitation: Early knee range of motion exercises and ambulation were encouraged within 24 hours post-operation.

Wound Management Protocol:

  • Patients were allowed to start bathing 48 hours post-op.
  • Dressing change on post-op day 3, using sterile technique:
  • Control Group: Covered with waterproof dressing (Opsite®).
  • Intervention Group: Covered with Ioband® in knee flexion.

Wound Care Instructions:

  • Keep covering material dry and clean; avoid irritation.
  • Report any signs of infection (redness, swelling, fever) to a doctor.
  • Avoid creams or powders unless prescribed.
  • Avoid scratching or rubbing around the wound.
  • Light activities permitted; avoid strenuous activities for 6 weeks.
  • Dressing should not be changed until advised, typically after 14 days unless signs of complications are observed.

Criteria for Dressing Change:

  • Change dressing if:
  • First waterproof dressing peels off grade II or III.
  • Second dressing has over 50% bleeding.
  • Suspected surgical site infection. Patients were also included in a chat group for wound care consultation.
Being tested
Isolate waterproof dressing (Opsite), Ioban coverage group
Keywords
total knee arthroplasty, Ioband® coverage waterproof dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Ioban coverage groupDevice

    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.

Study groups in NCT06943053
Study groupRoleWhat they receive
Control Group: Isolated waterproof dressing (Opsite®).Active comparatorIsolated waterproof dressing (Opsite®).
Receives: Device: Isolate waterproof dressing (Opsite)
Ioban Coverage groupExperimentalParticipants 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
Receives: Device: Ioban coverage group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 14 days postoperation

Secondary outcomes (4)
  1. Degree of peel off wound

    There are 4 types of Characteristics of the Wound Sealant Leakage Level 0: No leakage of the plastic sealant. No need to open the wound Level 1: Plastic sealant leaks around the edges but not into the wound. No need to open the wound Level 2: Plastic sealant leaks around the edges up to the wound edge. Open the wound and re-seal with a new sealant Level 3: Plastic sealant leaks deep into the wound edges. Open the wound and re-seal with a new sealant

    Measured: 14 days postoperation

  2. Satisfactory of patient

    • Satisfactory of patient: (score1-10)
    • Comfort for wound care (score 0-10)
    • Difficult to take a bath (score 0-10)
    • Pain on remove dressing (score 0-10)
    • Cost for Dressing after D/C

    Measured: 14 days post-operation

  3. Post op Range of motion of knee

    Degree of flexion

    Measured: At 2 weeks, 6 weeks and 3 months postoperation

  4. Wound-related Complication

    Wound-related Complication

    • Skin bleb, redness
    • Dehiscence
    • Subcutaneous hematoma
    • Surgical site infection

    Measured: At 2 weeks, 6 weeks and 3 months postoperation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2025
  2. Study start6 Apr 2025
  3. Primary completion6 Apr 2026 (estimated)
  4. Study completion16 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06943053
Sponsor's protocol ID
TUH wound coverage after TKA
Acronym
Wound coverage
Status last verified
Apr 2025
First submitted
9 Apr 2025
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The datasets analyzed during the current study are not available due to protect study participant privacy.

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Isolate waterproof dressing (Opsite) and Ioban coverage group in people with Postoperative Wound Care After TKA, run by Thammasat University Hospital at 2 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Krit Boontanapibul, M.D. (66613957799, krit.boontanapibul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of change wound dressing (time frame: 14 days postoperation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06943053, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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