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

Official title

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

Overview

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.

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.

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.

Primary outcome measures

• Number of change wound dressing [Time frame: 14 days postoperation]

Secondary outcome measures (4)

• Degree of peel off wound [Time frame: 14 days postoperation]
• Satisfactory of patient [Time frame: 14 days post-operation]
• Post op Range of motion of knee [Time frame: At 2 weeks, 6 weeks and 3 months postoperation]
• Wound-related Complication [Time frame: At 2 weeks, 6 weeks and 3 months postoperation]

Eligibility criteria

Inclusion criteria

• Primary unilateral TKA
• Age 55-80 yrs

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Thailand · 2 centers

• Thammasat University Hospital — Pathum Thani
• Department of Orthopaedics, Thammasat University — Pathum Thani

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

Identifiers

NCT: NCT06943053 · TUH wound coverage after TKA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗