Postoperative Complication
Conditions
Keywords
dressing, TKA
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.
Interventions
OTHERAQUACEL® Ag Surgical dressing (study group)
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.
OTHERSofra-Tulle® dressing (control group)
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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Pain Scores on the Visual Analog Scale | two weeks after surgery | overall pain management, and removal when using the dressings |
Outcome results
None listed