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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Joint Arthroplasty; Self-adhesive Silicone Gel Waterproof Dressing; Gauze Dressing
• Intervention / Treatment: Device: Self-adhesive silicone gel waterproof dressing; Device: Sterile gauze dressing

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Long Hua; Phone Number: +8615099182364; Email: hualong_xmu@163.com
• Study Contact Backup: Name: Li Cao; Phone Number: +8613909915960; Email: xjbone@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-adhesive silicone gel waterproof dressing group; Self-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery	Device: Self-adhesive silicone gel waterproof dressing; Self-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery.
Active Comparator: Sterile gauze dressing group; Sterile gauze dressing is used after artificial joint replacement surgery	Device: Sterile gauze dressing; Sterile gauze dressing is used after artificial joint replacement surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Infection control rate	Calculate the infection control rate in the two groups	One month and 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alanine Aminotransferase (ALT)	An enzyme found in the liver that helps convert proteins into energy. Elevated levels indicate liver damage. Normal range: 10 to 40 units per liter (U/L)	One day before surgery and one day after surgery
Aspartate Aminotransferase (AST)	An enzyme found in the liver and other tissues. High levels can indicate liver damage but are less specific than ALT. Normal range: 10 to 40 units per liter (U/L)	One day before surgery and one day after surgery
Serum Creatinine	Measures the level of creatinine in the blood. Elevated levels can indicate impaired kidney function. Normal range: 62 to 115 micromoles per liter (µmol/L).	One day before surgery and one day after surgery
Blood Urea Nitrogen （BUN）	Measures the amount of nitrogen in the blood that comes from urea. Elevated BUN levels can indicate impaired kidney function. Normal range: 2.5 to 7.1 millimoles per liter (mmol/L).	One day before surgery and one day after surgery
X-ray	X-ray of surgery site.	One day before surgery and three months after surgery.
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.	One day before surgery and three months after surgery.
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.	One day before surgery and three months after surgery.
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.	One day before surgery and three months after surgery.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Xinjiang Medical University
• Investigators: Study Chair: Li Cao, The first affliated hospital, Xinjiang medical university

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 15, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 15, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: RCT; total joint arthroplasty; self-adhesive silicone gel waterproof dressing; gauze dressing
• Other Study ID Numbers: XJ202405-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Other researchers can contact the corresponding author after the research publishing.
• IPD Sharing Time Frame: Other researchers can contact the corresponding author after the research publishing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No