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

NCT02445300 | Completed Phase 4 DMC

• 1 other identifier: CMPRG8C0711
• Study Type: interventional
• Target: 285
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Postoperative Complication

Keywords

dressing; TKA

Outcome Measures

Primary Outcomes (4)

• Wound Care Efficacy

  Wear time, No. of dressing change,

  an expected average of 5 days at the duration of hospital stay

• Number of Participants with Adverse Events

  Blister formation, wound erythema, discharge and necrosis

  Three months after surgery

• ASEPSIS score

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

  2 weeks after surgery

• Surgical site infection (SSI)

  Superficial or deep infection of the wound

  Three months after surgery

Secondary Outcomes (3)

• Pain Scores on the Visual Analog Scale

  two weeks after surgery

• Comfort scale

  two weeks after surgery

• Ease scale

  two weeks after surgery

Study Arms (2)

AQUACEL® Ag Surgical dressing

ACTIVE COMPARATOR

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.

Other: AQUACEL® Ag Surgical dressing (study group)

Sofra-Tulla® dressing

ACTIVE COMPARATOR

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.

Other: Sofra-Tulle® dressing (control group)

Interventions

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.

AQUACEL® Ag Surgical 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.

Sofra-Tulla® dressing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Two hundred and eighty five patients who were scheduled for primary unilateral MIS-TKA were enrolled in the study period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Postoperative Complications

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• FENG-CHIH KUO, MD

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Feng Chih Kuo

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: May 15, 2015
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 15, 2015

Record last verified: 2015-05