Does Ioband Coverage Waterproof Dressing Provide Better Outcome Than Isolate Waterproof Dressing After Primary Total Knee Arthroplasty? A Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 96
- Locations
- 2
- Primary Endpoint
- Number of change wound dressing
Study Overview
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:
- 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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control Group: Isolated waterproof dressing (Opsite®).
Isolated waterproof dressing (Opsite®).
Intervention: Isolate waterproof dressing (Opsite) (Device)
Ioban Coverage group
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
Intervention: Ioban coverage group (Device)
Outcomes
Primary Outcomes
Number of change wound dressing
Time Frame: 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 Outcomes
- Degree of peel off wound(14 days postoperation)
- Satisfactory of patient(14 days post-operation)
- Post op Range of motion of knee(At 2 weeks, 6 weeks and 3 months postoperation)
- Wound-related Complication(At 2 weeks, 6 weeks and 3 months postoperation)
Investigators
Yot Tanariyakul
Krit Boontanapibul
Thammasat University Hospital