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
About this trial
This is an interventional treatment trial for Postoperative Complication focused on measuring dressing, TKA
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.
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
NCT ID
NCT02445300
First Posted
April 14, 2015
Last Updated
May 12, 2015
Sponsor
Chang Gung Memorial Hospital
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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