Allevyn Gentle Border dressing versus control dressing in patients with rotator cuff repair

Phase 1

Conditions: To expand the range of dressing options for managing surgical wounds from rotator cuff repair
Injury, Occupational Diseases, Poisoning

Registration Number: ISRCTN97372145

Lead Sponsor: West China Hospital of Sichuan University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 68

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following primary outcome measures will be assessed using data collected from study records at 1, 2 and 4 weeks after surgery:<br>1. Incidence rate of wound complications<br>2. Calculating the cost-effectiveness of wound care (The cost-effectiveness of wound care will be 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 Outcome Measures

Name	Time	Method
The following secondary outcome measures will be assessed, unless stated, using data collected from study records at 1, 2 and 4 weeks after surgery:<br>1. Wound healing rate<br>2. Healing time<br>3. Dressing wear time <br>4. Number of dressing changes <br>5. Clinician's evaluation of dressing performance characteristics measured using a Likert 4-point scoring method<br>6. Patient's evaluation of the dressing measured using a Likert 4-point scoring method<br>