Clinical Efficacy of Self-adhesive Silicone Gel Waterproof Dressings Versus Conventional Dressings in the Healing of Incisions After Total Joint Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty

NCT03274466

Surgical Wound Revision Total Knee Arthroplasty Wounds and Injuries +6 more

COMPLETED NA

Efficacy and Patient Satisfaction With AQUACEL® Ag Surgical Dressing Compared to Standard Surgical Dressing

NCT01258270

Wound Healing

COMPLETED NA

Surgical Adhesive Drapes for Prevention and Healing of Wound Infections After Total Hip Arthroplasty

NCT02707302

Hip Replacement

COMPLETED NA

SMART Dressing for Hypertrophic Scar Treatment Post-Total Knee/Hip Arthroplasty

NCT03849274

Knee Arthropathy Hip Arthropathy Hypertrophic Scar

COMPLETED EARLY_PHASE1

Efficacy of Modified Robert Jones Bandages on Reducing Invisible Blood Loss After Total Knee Arthroplasty

NCT02701946

Postoperative Blood Loss

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Self-adhesive Silicone Gel Waterproof Dressing Gauze Dressing Total Joint Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Self-adhesive silicone gel waterproof dressing group

Self-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery

Group Type EXPERIMENTAL

Self-adhesive silicone gel waterproof dressing

Intervention Type DEVICE

Self-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery.

Sterile gauze dressing group

Sterile gauze dressing is used after artificial joint replacement surgery

Group Type ACTIVE_COMPARATOR

Sterile gauze dressing

Intervention Type DEVICE

Sterile gauze dressing is used after artificial joint replacement surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self-adhesive silicone gel waterproof dressing

Self-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery.

Intervention Type DEVICE

Sterile gauze dressing

Sterile gauze dressing is used after artificial joint replacement surgery.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes