Clinical trial NCT02445300: Efficacy of Wound Care and Reduction of Wound Complications by Use of AQUACEL® Ag Surgical Dressing in MIS TKA
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Complication
Keywords: dressing
TKA
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 285
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound Care Efficacy
timeFrame: an expected average of 5 days at the duration of hospital stay
measure: Number of Participants with Adverse Events
timeFrame: Three months after surgery
measure: ASEPSIS score
timeFrame: 2 weeks after surgery
measure: Surgical site infection (SSI)
timeFrame: Three months after surgery
Secondary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: two weeks after surgery
measure: Comfort scale
timeFrame: two weeks after surgery
measure: Ease scale
timeFrame: two weeks after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: FENG-CHIH KUO, MD
role: STUDY_CHAIR
References: