Evaluation of Ioband Coverage Waterproof Dressing Versus Isolated Waterproof Dressing After Primary Total Knee Arthroplasty (Wound coverage)

Thammasat University Hospital

Status: Enrolling

Conditions: Postoperative Wound Care After TKA

Treatments: Device: Ioban coverage group; Device: Isolate waterproof dressing (Opsite)

Study type: Interventional

Funder types: Other

Identifiers

NCT06943053

TUH wound coverage after TKA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Control Group: Isolated waterproof dressing (Opsite®).

Active Comparator group

Description:

Isolated waterproof dressing (Opsite®).

Treatment:

Device: Isolate waterproof dressing (Opsite)

Ioban Coverage group

Experimental group

Description:

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

Treatment:

Device: Ioban coverage group