- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: AQUACEL® Ag Surgical dressing
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 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.
|
Active Comparator: Sofra-Tulla® dressing
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Care Efficacy
Time Frame: an expected average of 5 days at the duration of hospital stay
|
Wear time, No. of dressing change,
|
an expected average of 5 days at the duration of hospital stay
|
Number of Participants with Adverse Events
Time Frame: Three months after surgery
|
Blister formation, wound erythema, discharge and necrosis
|
Three months after surgery
|
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
|
2 weeks after surgery
|
Surgical site infection (SSI)
Time Frame: Three months after surgery
|
Superficial or deep infection of the wound
|
Three months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Scores on the Visual Analog Scale
Time Frame: two weeks after surgery
|
overall pain management, and removal when using the dressings
|
two weeks after surgery
|
Comfort scale
Time Frame: two weeks after surgery
|
The dressing is comfort in use and ease of application (excellent, good, fair or poor)
|
two weeks after surgery
|
Ease scale
Time Frame: two weeks after surgery
|
The dressing is ease of application and removal (excellent, good, fair or poor)
|
two weeks after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Feng-Chih Kuo, MD, Chang Gung Memorial Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMPRG8C0711
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Complication
-
Zealand University HospitalCompletedComplication, Postoperative | Cardiovascular ComplicationDenmark
-
Universidade Federal de Santa MariaCompletedComplication, Postoperative | Cardiac ComplicationBrazil
-
Universitätsmedizin MannheimCompletedImplant Complication | Complication, Postoperative | Implant Site Infection
-
Academisch Medisch Centrum - Universiteit van Amsterdam...UMC UtrechtTerminatedComplication, PostoperativeNetherlands
-
Rigshospitalet, DenmarkCompletedComplication, PostoperativeDenmark
-
Ain Shams UniversityUnknownComplication, PostoperativeEgypt
-
Barretos Cancer HospitalCompletedComplication, PostoperativeBrazil
-
Azienda Ospedaliera S. Maria della MisericordiaCompletedLiver Transplantation | Postoperative Renal Complication | Postoperative Pulmonary Complication | Postoperative Cardiovascular Complication | Blood Components TransfusionItaly
-
Mark CoburnCompletedMortality | Complication, PostoperativeSpain, Germany, Netherlands, France, Denmark, Israel, Belgium, Switzerland, Greece, Ireland, Serbia, Romania, Poland, Turkey, Portugal, Austria, Georgia, North Macedonia, Russian Federation, Ukraine
-
Institute of Liver and Biliary Sciences, IndiaCompletedComplication, Postoperative | Regeneration LiverIndia
Clinical Trials on AQUACEL® Ag Surgical dressing (study group)
-
Golden Jubilee National HospitalConvaTec Inc.Withdrawn
-
Hospital Universitario de CanariasTerminatedWound Infection, SurgicalSpain
-
Rothman Institute OrthopaedicsUnknown
-
Bio-medical Carbon Technology Co., Ltd.Chung Shan Medical UniversityTerminated
-
ULURU Inc.Terminated
-
ConvaTec Inc.CompletedLeg UlcersUnited Kingdom
-
University Hospital, GhentCompletedBurn Wounds - Partial Thickness (2nd Degree)Belgium
-
NYU Langone HealthCompleted
-
Kansas City Heart Rhythm InstituteCompletedWounds and Injuries | InfectionsUnited States
-
Medical University of WarsawCompletedSurgical Site Infection | Infection; Cesarean SectionPoland