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

Primary Purpose

Postoperative Complication

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
AQUACEL® Ag Surgical dressing (study group)
Sofra-Tulle® dressing (control group)
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complication focused on measuring dressing, TKA

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    AQUACEL® Ag Surgical dressing

    Sofra-Tulla® dressing

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Wound Care Efficacy
    Wear time, No. of dressing change,
    Number of Participants with Adverse Events
    Blister formation, wound erythema, discharge and necrosis
    ASEPSIS score
    Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria and Stay as inpatient
    Surgical site infection (SSI)
    Superficial or deep infection of the wound

    Secondary Outcome Measures

    Pain Scores on the Visual Analog Scale
    overall pain management, and removal when using the dressings
    Comfort scale
    The dressing is comfort in use and ease of application (excellent, good, fair or poor)
    Ease scale
    The dressing is ease of application and removal (excellent, good, fair or poor)

    Full Information

    First Posted
    April 14, 2015
    Last Updated
    May 12, 2015
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02445300
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Complication
    Keywords
    dressing, TKA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    285 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AQUACEL® Ag Surgical dressing
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Sofra-Tulla® dressing
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    AQUACEL® Ag Surgical dressing (study group)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Sofra-Tulle® dressing (control group)
    Intervention Description
    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 Outcome Measure Information:
    Title
    Wound Care Efficacy
    Description
    Wear time, No. of dressing change,
    Time Frame
    an expected average of 5 days at the duration of hospital stay
    Title
    Number of Participants with Adverse Events
    Description
    Blister formation, wound erythema, discharge and necrosis
    Time Frame
    Three months after surgery
    Title
    ASEPSIS score
    Description
    Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria and Stay as inpatient
    Time Frame
    2 weeks after surgery
    Title
    Surgical site infection (SSI)
    Description
    Superficial or deep infection of the wound
    Time Frame
    Three months after surgery
    Secondary Outcome Measure Information:
    Title
    Pain Scores on the Visual Analog Scale
    Description
    overall pain management, and removal when using the dressings
    Time Frame
    two weeks after surgery
    Title
    Comfort scale
    Description
    The dressing is comfort in use and ease of application (excellent, good, fair or poor)
    Time Frame
    two weeks after surgery
    Title
    Ease scale
    Description
    The dressing is ease of application and removal (excellent, good, fair or poor)
    Time Frame
    two weeks after surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    FENG-CHIH KUO, MD
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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