NCT02445300

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Complication

Interventions

Type	Name	Description
OTHER	AQUACEL® 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.
OTHER	Sofra-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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-07-01
• Completion: 2014-10-01
• First posted: 2015-05-15
• Last updated: 2015-05-15