Clinical Efficacy of Self-adhesive Silicone Gel Waterproof Dressings Versus Conventional Dressings in the Healing of Incisions After Total Joint Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-adhesive silicone gel waterproof dressing, Sterile gauze dressing.
- Who it may be relevant to
- Registry conditions: Self-adhesive Silicone Gel Waterproof Dressing, Gauze Dressing, Total Joint Arthroplasty. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Efficacy of Self-adhesive Silicone Gel Waterproof Dressings Versus Conventional Dressings in the Healing of Incisions After Total Joint Arthroplasty: a Prospective, Randomized Controlled Trial Study
Overview
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.
Interventions
- Device Self-adhesive silicone gel waterproof dressing
Self-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery. - Device Sterile gauze dressing
Sterile gauze dressing is used after artificial joint replacement surgery.
Primary outcome measures
- Infection control rate [Time frame: One month and three month after surgery]
- Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score) [Time frame: One day before surgery, three month after surgery]
- Modified Severity Score (MSS) [Time frame: One day before surgery, three month after surgery]
Secondary outcome measures (8)
- X-ray [Time frame: One day before surgery and three months after surgery.]
- American Knee Society Score (AKS score) [Time frame: One day before surgery and three months after surgery.]
- The Harris Hip Score (HHS) [Time frame: One day before surgery and three months after surgery.]
- Visual Analog Scale (VAS score) [Time frame: One day before surgery and three months after surgery.]
- Alanine Aminotransferase (ALT) [Time frame: One day before surgery and one day after surgery]
- Aspartate Aminotransferase (AST) [Time frame: One day before surgery and one day after surgery]
- Serum Creatinine [Time frame: One day before surgery and one day after surgery]
- Blood Urea Nitrogen （BUN） [Time frame: One day before surgery and one day after surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- Active infection at the site of intravenous or joint injection;
- long-term use of anticoagulants or antiplatelet drugs due to other diseases;
- Have sepsis or positive blood culture within the last 30 days;
- Radiotherapy and chemotherapy are required due to neoplastic diseases;
- Receiving systemic glucocorticoid therapy (prednisone > 10mg/ day or equivalent hormone medication);
- severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);
- Have a history of drug abuse;
- Treatment of bone marrow or other transplants with immunosuppressive drugs;
- Pregnant, parturient and lactating women;
- Participating in other clinical trials;
- Researchers believe that other reasons are not appropriate for clinical trial participants.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06467721 · XJ202405-01