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

NCT06467721 | Not Yet Recruiting DMC

• 1 other identifier: XJ202405-01
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (3)

• Infection control rate

  Calculate the infection control rate in the two groups

  One month and three month after surgery

• 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.

  One day before surgery, three month after surgery

• 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.

  One day before surgery, three month after surgery

Secondary Outcomes (8)

• X-ray

  One day before surgery and three months after surgery.

• American Knee Society Score (AKS score)

  One day before surgery and three months after surgery.

• The Harris Hip Score (HHS)

  One day before surgery and three months after surgery.

• Visual Analog Scale (VAS score)

  One day before surgery and three months after surgery.

• Alanine Aminotransferase (ALT)

  One day before surgery and one day after surgery

Study Arms (2)

Self-adhesive silicone gel waterproof dressing group

EXPERIMENTAL

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

Device: Self-adhesive silicone gel waterproof dressing

Sterile gauze dressing group

ACTIVE COMPARATOR

Sterile gauze dressing is used after artificial joint replacement surgery

Device: Sterile gauze dressing

Interventions

Self-adhesive silicone gel waterproof dressing DEVICE

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

Self-adhesive silicone gel waterproof dressing group

Sterile gauze dressing DEVICE

Sterile gauze dressing is used after artificial joint replacement surgery.

Sterile gauze dressing group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Xinjiang Medical University: lead

Study Officials

• Li Cao

  The first affliated hospital, Xinjiang medical university

  STUDY CHAIR

Central Study Contacts

Long Hua

CONTACT

+8615099182364; hualong_xmu@163.com

Li Cao

CONTACT

+8613909915960; xjbone@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 21, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Other researchers can contact the corresponding author after the research publishing.