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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorThammasat University Hospital

About this 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.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Primary unilateral TKA

Age 55-80 yrs

Disqualifiers

Chronic Skin disease such as Psoriasis

Chronic steroid use

Allergy to skin adhesive, Cover wound

Robotic TKA

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Control Group: Isolated waterproof dressing (Opsite®).Active comparator 1 intervention
Group B: Ioban Coverage groupExperimental treatment 1 intervention

Trial outcomes

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

Time frame
14 days postoperation

Secondary outcomes

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

Time frame
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

Time frame
14 days post-operation
3

Post op Range of motion of knee

Degree of flexion

Time frame
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

Time frame
At 2 weeks, 6 weeks and 3 months postoperation

Other outcomes

Sponsors and contacts

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