Evaluation of Ioband Coverage Waterproof Dressing Versus Isolated Waterproof Dressing After Primary Total Knee Arthroplasty
- Conditions
- Postoperative Wound Care After TKA
- Registration Number
- NCT06943053
- Lead Sponsor
- Thammasat University Hospital
- Brief 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.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- Primary unilateral TKA
- Age 55-80 yrs
- Chronic Skin disease such as Psoriasis
- Chronic steroid use
- Allergy to skin adhesive, Cover wound
- Robotic TKA
- Iodine allergy
- Not follow protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of change wound dressing 14 days postoperation 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
- Secondary Outcome Measures
Name Time Method Degree of peel off wound 14 days postoperation 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
Satisfactory of patient 14 days post-operation * 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/CPost op Range of motion of knee At 2 weeks, 6 weeks and 3 months postoperation Degree of flexion
Wound-related Complication At 2 weeks, 6 weeks and 3 months postoperation Wound-related Complication
* Skin bleb, redness
* Dehiscence
* Subcutaneous hematoma
* Surgical site infection
Trial Locations
- Locations (2)
Thammasat University Hospital
🇹🇭Pathum Thani, Khlong luang, Thailand
Department of Orthopaedics, Thammasat University
🇹🇭Pathumthani, Thailand