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:
- Does Ioband® coverage waterproof dressing significantly decrease the degree of peel-off compared to standard waterproof dressing?
- Does Ioband® coverage reduce the number of wound dressing changes required post-operatively?
- 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:
- Randomization: Participants will be randomly assigned to receive either the Ioband® coverage waterproof dressing or the standard waterproof dressing.
- Application of Dressings: Participants will have the assigned dressing applied to their surgical site post-operatively.
- Assessment of Peel-Off Degree: Participants will undergo assessments to evaluate the degree of peel-off of the dressing over a specified time.
- Wound Dressing Changes: Participants will have their dressing changed as per routine care protocols, with documentation of the number of changes.
- 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.
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:
- Naproxen (250 mg)
- Omeprazole (20 mg)
- Acetaminophen (500 mg)
- 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.
Eligibility
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