About this trial
The efficacy of using self-adhesive silicone gel waterproof dressings versus conventional gauze dressings for recovery after total joint arthroplasty (TJA) remains unclear. In our study, we conducted a prospective, randomized controlled trial to compare these two types of dressings. Patients were divided into two groups following TJA, and we collected primary outcome measures such as skin infection rate and re-operation rate. Additionally, we gathered blood inflammatory indicators, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), to evaluate the effectiveness of the two treatments. Finally, we perform one year follow up including REEDA score, MSS score to evaluate the recovery of the skin.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years old, gender is not limited;
Meet the diagnostic criteria for artificial joint replacement;
Initial joint replacement surgery;
Voluntary and signed informed consent.
Disqualifiers
Allergic to self-adhesive silicone rubber waterproof dressing;
Patients with severe knee joint infection who cannot undergo artificial joint replacement;
Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30ml/min;
periprosthesis infection after multiple joint replacement;
Trial design
Parallel
Treatments tested in this trial
Self-adhesive silicone gel waterproof dressing
DeviceSelf-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery.
Sterile gauze dressing
DeviceSterile gauze dressing is used after artificial joint replacement surgery.
Treatment groups
Trial outcomes
Primary outcomes
Infection control rate
Calculate the infection control rate in the two groups
Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score)
The REEDA score is a clinical tool used to assess the healing of perineal wounds and other skin wounds, particularly after childbirth. REEDA stands for Redness, Edema, Ecchymosis, Discharge, and Approximation. Each of these five parameters is scored on a scale from 0 to 3, with higher scores indicating more severe symptoms. The total REEDA score can range from 0 to 15.
Modified Severity Score (MSS)
This score is often used in dermatology to evaluate the severity of conditions such as atopic dermatitis or other chronic skin disorders. The MSS score helps clinicians to quantify the extent and severity of skin involvement, aiding in treatment decisions and monitoring progress.
Secondary outcomes
X-ray
X-ray of surgery site.
American Knee Society Score (AKS score)
American Knee Society Score is used to evaluate the outcomes of knee replacement surgery. This scoring system consists of two main components: the knee score and the function score.
The Harris Hip Score (HHS)
The Harris Hip Score (HHS) is a widely used clinical tool for assessing the outcomes of hip surgeries, particularly hip replacements. Developed by Dr. William Harris in 1969, it evaluates various aspects of hip function and pain to provide an overall score that reflects the patient's condition. The higher the score, the better the result is.
Visual Analog Scale (VAS score)
The VAS score, or Visual Analog Scale, is a tool commonly used to measure a person's level of pain. The VAS is a simple, subjective measure that consists of a straight line, typically 10 centimeters long, anchored by two endpoints. One end of the line represents "no pain" and the other end represents "worst pain imaginable." For example, if the VAS line is 10 cm long and the patient's mark is at 7 cm from the "no pain" end, their pain score would be 7 out of 10.
Locations
Sponsors and contacts
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