ISRCTN97372145
Active, not recruiting
Phase 1
A randomized controlled non-inferiority trial comparing the efficacy of Allevyn Gentle Border dressing to a conventional wound dressing in patients with surgical wounds from rotator cuff repair
West China Hospital of Sichuan University0 sites68 target enrollmentMay 1, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- West China Hospital of Sichuan University
- Enrollment
- 68
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age of patient 18 to 80 years
- •2\. Initial rotator cuff repair
- •3\. The surgical procedures will be performed by the same surgeon, who uses the same surgical technique and suture material
- •4\. Good patient compliance and regular follow\-ups are essential
- •5\. Voluntary participation in the study with signed informed consent
Exclusion Criteria
- •1\. Combined with hypertension, diabetes, hypoproteinemia, malnutrition (defined as body mass index or BMI \< 18\.5 kg/m2\), severe obesity (defined as 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
Outcomes
Primary Outcomes
Not specified
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