Self-adhesive Silicone Gel Waterproof DressingYesNCT06467721
Clinical Efficacy of Self-adhesive Silicone Gel Waterproof Dressings Versus Conventional Dressings in the Healing of Incisions After Total Joint Arthroplasty
A study testing Self-adhesive silicone gel waterproof dressing and Sterile gauze dressing in people with Self-adhesive Silicone Gel Waterproof Dressing and Gauze Dressing, run by First Affiliated Hospital of Xinjiang Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-adhesive Silicone Gel Waterproof Dressing, Gauze Dressing, Total Joint Arthroplasty
- What is being tested?
- Self-adhesive silicone gel waterproof dressing and Sterile gauze dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Self-adhesive silicone gel waterproof dressing, Sterile gauze dressing
- Keywords
- self-adhesive silicone gel waterproof dressing, gauze dressing, total joint arthroplasty, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-adhesive silicone gel waterproof dressingDevice
Self-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery.
Sterile gauze dressingDevice
Sterile gauze dressing is used after artificial joint replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| Self-adhesive silicone gel waterproof dressing group | Experimental | Self-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery Receives: Device: Self-adhesive silicone gel waterproof dressing |
| Sterile gauze dressing group | Active comparator | Sterile gauze dressing is used after artificial joint replacement surgery Receives: Device: Sterile gauze dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection control rate
Calculate the infection control rate in the two groups
Measured: 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.
Measured: 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.
Measured: One day before surgery, three month after surgery
Secondary outcomes (8)
X-ray
X-ray of surgery site.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One day before surgery and three months after surgery.
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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: One day before surgery and one day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-adhesive Silicone Gel Waterproof DressingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Hua, First Affiliated Hospital of Xinjiang Medical University
- Investigators
- Li Cao, Study chair, The first affliated hospital, Xinjiang medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467721
- Sponsor's protocol ID
- XJ202405-01
- Acronym
- Yes
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers can contact the corresponding author after the research publishing.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06467721
- Acronym / sponsor ID
- Yes / XJ202405-01
- Keywords
- self-adhesive silicone gel waterproof dressing, gauze dressing, total joint arthroplasty, RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-adhesive silicone gel waterproof dressing group | Experimental | Device: Self-adhesive silicone gel waterproof dressingSelf-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery |
| Sterile gauze dressing group | Active comparator | Device: Sterile gauze dressingSterile gauze dressing is used after artificial joint replacement surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-adhesive silicone gel waterproof dressingSelf-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery. | Device | Self-adhesive silicone gel waterproof dressing group |
| Sterile gauze dressingSterile gauze dressing is used after artificial joint replacement surgery. | Device | Sterile gauze dressing group |
Primary outcome
Infection control rate
Time frame: One month and three month after surgery
Calculate the infection control rate in the two groups
Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score)
Time frame: One day before surgery, three month after surgery
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.
Modified Severity Score (MSS)
Time frame: One day before surgery, three month after surgery
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.
8 secondary outcomes
X-ray
Time frame: One day before surgery and three months after surgery.
American Knee Society Score (AKS score)
Time frame: One day before surgery and three months after surgery.
The Harris Hip Score (HHS)
Time frame: One day before surgery and three months after surgery.
Visual Analog Scale (VAS score)
Time frame: One day before surgery and three months after surgery.
Alanine Aminotransferase (ALT)
Time frame: One day before surgery and one day after surgery
Aspartate Aminotransferase (AST)
Time frame: One day before surgery and one day after surgery
Serum Creatinine
Time frame: One day before surgery and one day after surgery
Blood Urea Nitrogen （BUN）
Time frame: One day before surgery and one day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Yes. Other researchers can contact the corresponding author after the research publishing.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Cao study chair
The first affliated hospital, Xinjiang medical university
Questions about this trial
What is this clinical trial studying?
A study testing Self-adhesive silicone gel waterproof dressing and Sterile gauze dressing in people with Self-adhesive Silicone Gel Waterproof Dressing and Gauze Dressing, run by First Affiliated Hospital of Xinjiang Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Long Hua (+8615099182364, hualong_xmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection control rate (time frame: One month and three month after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.