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

Phase 4

Completed

• Conditions: Postoperative Complication

• Registration Number: NCT02445300
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-07
• Study Completion: 2014-10
• Study First Submitted: 2015-04-14
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-12
• Last Update Submitted: 2015-05-12
• Study First Posted: 2015-05-15
• Last Update Posted: 2015-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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