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Completed

NCT Number: NCT02445300

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

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).

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Key information

Conditions

Postoperative Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AQUACEL® Ag Surgical dressing (study group)

Other

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.

Sofra-Tulle® dressing (control group)

Other

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.

Primary outcomes

  1. Wound Care Efficacy

    Time frame: an expected average of 5 days at the duration of hospital stay

    Wear time, No. of dressing change,

  2. Number of Participants with Adverse Events

    Time frame: Three months after surgery

    Blister formation, wound erythema, discharge and necrosis

  3. ASEPSIS score

    Time frame: 2 weeks after surgery

    Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria and Stay as inpatient

  4. Surgical site infection (SSI)

    Time frame: Three months after surgery

    Superficial or deep infection of the wound

Secondary outcomes

  1. Pain Scores on the Visual Analog Scale

    Time frame: two weeks after surgery

    overall pain management, and removal when using the dressings

  2. Comfort scale

    Time frame: two weeks after surgery

    The dressing is comfort in use and ease of application (excellent, good, fair or poor)

  3. Ease scale

    Time frame: two weeks after surgery

    The dressing is ease of application and removal (excellent, good, fair or poor)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 15, 2015
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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