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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Xinjiang Medical University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Self-adhesive silicone gel waterproof dressing

    Device

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

  • Sterile gauze dressing

    Device

    Sterile gauze dressing is used after artificial joint replacement surgery.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Self-adhesive silicone gel waterproof dressing groupExperimental treatment 1 intervention
Group B: Sterile gauze dressing groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Infection control rate

Calculate the infection control rate in the two groups

Time frame
One month and three month after surgery
2

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.

Time frame
One day before surgery, three month after surgery
3

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.

Time frame
One day before surgery, three month after surgery

Secondary outcomes

1

X-ray

X-ray of surgery site.

Time frame
One day before surgery and three months after surgery.
2

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.

Time frame
One day before surgery and three months after surgery.
3

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.

Time frame
One day before surgery and three months after surgery.
4

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.

Time frame
One day before surgery and three months after surgery.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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