Clinical trial NCT06467721: Clinical Efficacy of Self-adhesive Silicone Gel Waterproof Dressings Versus Conventional Dressings in the Healing of Incisions After Total Joint Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Self-adhesive Silicone Gel Waterproof Dressing
Gauze Dressing
Total Joint Arthroplasty
Keywords: self-adhesive silicone gel waterproof dressing
gauze dressing
total joint arthroplasty
RCT
Lead sponsor: First Affiliated Hospital of Xinjiang Medical University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: Inclusion Criteria:

1. Age ≥18 years old, gender is not limited;
2. Meet the diagnostic criteria for artificial joint replacement;
3. Initial joint replacement surgery;
4. Voluntary and signed informed consent.

Exclusion Criteria:

1. Allergic to self-adhesive silicone rubber waterproof dressing;
2. Patients with severe knee joint infection who cannot undergo artificial joint replacement;
3. Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30ml/min;
4. periprosthesis infection after multiple joint replacement;
5. Active infection at the site of intravenous or joint injection;
6. long-term use of anticoagulants or antiplatelet drugs due to other diseases;
7. Have sepsis or positive blood culture within the last 30 days;
8. Radiotherapy and chemotherapy are required due to neoplastic diseases;
9. Receiving systemic glucocorticoid therapy (prednisone \> 10mg/ day or equivalent hormone medication);
10. severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);
11. Have a history of drug abuse;
12. Treatment of bone marrow or other transplants with immunosuppressive drugs;
13. Pregnant, parturient and lactating women;
14. Participating in other clinical trials;
15. Researchers believe that other reasons are not appropriate for clinical trial participants.

Primary outcomes:
measure: Infection control rate
timeFrame: One month and three month after surgery
measure: Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score)
timeFrame: One day before surgery, three month after surgery
measure: Modified Severity Score (MSS)
timeFrame: One day before surgery, three month after surgery
Secondary outcomes:
measure: X-ray
timeFrame: One day before surgery and three months after surgery.
measure: American Knee Society Score (AKS score)
timeFrame: One day before surgery and three months after surgery.
measure: The Harris Hip Score (HHS)
timeFrame: One day before surgery and three months after surgery.
measure: Visual Analog Scale (VAS score)
timeFrame: One day before surgery and three months after surgery.
measure: Alanine Aminotransferase (ALT)
timeFrame: One day before surgery and one day after surgery
measure: Aspartate Aminotransferase (AST)
timeFrame: One day before surgery and one day after surgery
measure: Serum Creatinine
timeFrame: One day before surgery and one day after surgery
measure: Blood Urea Nitrogen （BUN）
timeFrame: One day before surgery and one day after surgery
Other outcomes:
Locations:
Study officials:
affiliation: The first affliated hospital, Xinjiang medical university
name: Li Cao
role: STUDY_CHAIR
References: