To expand the range of dressing options for managing surgical wounds from rotator cuff repair Injury, Occupational Diseases, Poisoning
Conditions
Interventions
This is a non-inferiority trial and cost-benefit analysis of silicone adhesive foam dressing for wound management after rotator cuff suture repair. The sample size will be 68 patients who will be rand
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years 2. Undergoing initial rotator cuff repair 3. Surgical procedures will be performed by the same surgeon using the same surgical technique and suture materials 4. Good patient compliance and regular follow-ups are essential 5. Voluntary participation in the study with signed informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with conditions that may affect wound healing, including hypertension, diabetes, hypoproteinemia, malnutrition (defined as body mass index or BMI 28 kg/m2), rheumatoid disease, tumor, connective tissue disease, hemophilia, limb vascular disease, psoriasis, radiation injury, gangrene, genetic diseases, anemia, gout, or other diseases that may affect wound healing 2. Long-term use of immunosuppressive agents, glucocorticoids, biological agents, anticoagulants, antiplatelet drugs, or no standardized adjustment and withdrawal pre-surgery 3. Long-term history of smoking or alcohol consumption 4. Preoperative history of surgery or infection at the surgical site 5. Scars, skin lesions, or rashes at the surgical site pre-surgery 6. Recent history (within 1 month) of invasive procedures, such as acupuncture, small needle knife, or drug injection at the surgical site 7. Psoriasis, eczema, dermatitis or other skin diseases 8. Allergic to any dressing components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures will be assessed using data collected from study records at 1, 2 and 4 weeks after surgery: 1. Incidence rate of wound complications 2. The cost-effectiveness of wound care, analyzed using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER). The total direct costs related to surgical wound care will include registration fees, dressing change costs, dressing costs and the cost of management of complications | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be assessed, unless stated, using data collected from study records at 1, 2 and 4 weeks after surgery: 1. Wound healing rate 2. Healing time 3. Dressing wear time 4. Number of dressing changes 5. Clinician's evaluation of dressing performance characteristics measured using a Likert 4-point scoring method 6. Patient's evaluation of the dressing measured using a Likert 4-point scoring method | — |
Countries
China
Contacts
Public ContactJinyu Wu
Outcome results
None listed