Efficacy of Wound Care and Reduction of Wound Complications by Use of AQUACEL® Ag Surgical Dressing in MIS TKA

Study Overview
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Brief Summary
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The investigators hypothesized that AQUACEL® Ag Surgical dressing would have a significant improvement in the efficacy of wound care and wound complications compared with traditional Sofra-Tulle® dressings after minimally invasive total knee arthroplasty (MIS-TKA).

Detailed Description
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Traditional adhesive dressing (Mepore®; Mölnlycke Health Care) for low limb arthroplasty wounds had blistering up to 26%. The jubilee dressing, which consisted of a highly absorbent Hydrofiber inner layer and (Aquacel; ConvaTec Inc.) and a viscoelastic hydrocolloid outer layer (DuoDERM Extra Thin; ConvaTec Inc.), was introduced for lower limb arthroplasty wounds with lower blistering rate (2% vs. 18%) and lower surgical site infection (1% vs. 3%) compared to traditional adhesive dressing. A new modern dressing regime (Aquacel Ag Surgical dressing; ConvaTec Inc.) also reported longer wear time, less dressing change and less blistering. In our institution, the standard wound care after TKA was an antimicrobial dressing (Sofra-Tulle®; Royal Chem. & Pharm. Co., Kaohsiung, Taiwan) in the inner layer and gauzes in the outer layer. The investigators hypothesized that AQUACEL® Ag Surgical dressing would have a significant improvement in the efficacy of wound care and wound complications compared with traditional Sofra-Tulle® dressings after MIS-TKA.

Official Title
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Efficacy of Wound Care and Reduction of Wound Complications by Use of AQUACEL® Ag Surgical Dressing in Minimally Invasive Total Knee Arthroplasty：A Prospective, Randomized Controlled Study

Conditions
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Postoperative Complication

Intervention / Treatment
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* Other: AQUACEL® Ag Surgical dressing (study group)
* Other: Sofra-Tulle® dressing (control group)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Two hundred and eighty five patients who were scheduled for primary unilateral MIS-TKA were enrolled in the study period. Exclusion Criteria: Patients with condition/comorbidity that could compromise wound healing, including varicose eczema, peripheral vascular disease, receiving immunosuppressive medications, corticosteroid abuse, chronic skin disease around the knee (e.g. psoriasis and chronic eczema) and having prior knee replacement, osteotomy or fracture of the ipsilateral knee.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AQUACEL® Ag Surgical dressing<br>AQUACEL® Ag Surgical dressing is used to cover the surgical wound in the OR. Clinical indications for removal of the AQUACEL® Ag Surgical dressing were leakage from the dressing beyond the hydrocolloid exterior layer and more than a 50% saturation of the Hydrofiber® inner layer. | Other: AQUACEL® Ag Surgical dressing (study group)<br>* The AQUACEL® Ag Surgical dressing was applied to the wound in the operating theater by the surgeon. Clinical indications for removal of the AQUACEL® Ag Surgical dressing were leakage from the dressing beyond the hydrocolloid exterior layer and more than a 50% saturation of the Hydrofiber® inner layer10. If there were no indications to change the dressing, it was changed at the day of discharge usually the 4th or 5th postoperative day (POD) and remained cover of the wound for 7 days except for exudate across the dressing.<br>|
| Active Comparator: Sofra-Tulla® dressing<br>The Sofra-Tulle® dressing was used in the OR and routinely changed at a daily basis. If there were strikethrough on the gauze, the nursing staff would proceed the dressing change automatically between the daily routine. | Other: Sofra-Tulle® dressing (control group)<br>* The Sofra-Tulle® dressing was applied to the wound in the operating theater by the surgeon. The Sofra-Tulle® dressing was routinely changed at a daily basis. If there were strikethrough on the gauze, the nursing staff would proceed the dressing change automatically between the daily routine. After discharge from the hospital, the family who had been taught well to do this job during the patient's stay in the hospital conducted the daily dressing change.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Care Efficacy | Wear time, No. of dressing change, | an expected average of 5 days at the duration of hospital stay | 
| Number of Participants with Adverse Events | Blister formation, wound erythema, discharge and necrosis | Three months after surgery | 
| ASEPSIS score | Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria and Stay as inpatient | 2 weeks after surgery | 
| Surgical site infection (SSI) | Superficial or deep infection of the wound | Three months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Visual Analog Scale | overall pain management, and removal when using the dressings | two weeks after surgery | 
| Comfort scale | The dressing is comfort in use and ease of application (excellent, good, fair or poor) | two weeks after surgery | 
| Ease scale | The dressing is ease of application and removal (excellent, good, fair or poor) | two weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dressing, TKA