Postoperative Complication Clinical Trial
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
Verified date | May 2015 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 285 |
Est. completion date | October 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound Care Efficacy | Wear time, No. of dressing change, | an expected average of 5 days at the duration of hospital stay | No |
Primary | Number of Participants with Adverse Events | Blister formation, wound erythema, discharge and necrosis | Three months after surgery | Yes |
Primary | ASEPSIS score | Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria and Stay as inpatient | 2 weeks after surgery | Yes |
Primary | Surgical site infection (SSI) | Superficial or deep infection of the wound | Three months after surgery | Yes |
Secondary | Pain Scores on the Visual Analog Scale | overall pain management, and removal when using the dressings | two weeks after surgery | No |
Secondary | Comfort scale | The dressing is comfort in use and ease of application (excellent, good, fair or poor) | two weeks after surgery | No |
Secondary | Ease scale | The dressing is ease of application and removal (excellent, good, fair or poor) | two weeks after surgery | No |
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