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Clinical Trials/ISRCTN97372145
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.

Registry
who.int
Start Date
May 1, 2024
End Date
October 31, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
West China Hospital of Sichuan University

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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