Efficacy of Wound Care and Reduction of Wound Complications by Use of AQUACEL® Ag Surgical Dressing in MIS TKA
- Conditions
- Postoperative Complication
- Interventions
- Other: AQUACEL® Ag Surgical dressing (study group)Other: Sofra-Tulle® dressing (control group)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 285
- Two hundred and eighty five patients who were scheduled for primary unilateral MIS-TKA were enrolled in the study period.
- 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
- Arm && Interventions
Group Intervention Description AQUACEL® Ag Surgical dressing AQUACEL® Ag Surgical dressing (study group) 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. Sofra-Tulla® dressing Sofra-Tulle® dressing (control group) 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.
- 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 Pain Scores on the Visual Analog Scale two weeks after surgery overall pain management, and removal when using the dressings
Comfort scale two weeks after surgery The dressing is comfort in use and ease of application (excellent, good, fair or poor)
Ease scale two weeks after surgery The dressing is ease of application and removal (excellent, good, fair or poor)