Pico ™ single use negative pressure wound therapy system compared to standard wound care with endoprosthetic care of the hip
Not Applicable
Recruiting
- Conditions
- T84.5T89.03Infection and inflammatory reaction due to internal joint prosthesis
- Registration Number
- DRKS00014259
- Lead Sponsor
- Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
BMI> 30
-Primary care with a hip endoprosthesis
-male and female patients over the age of 18
Exclusion Criteria
known diseases affecting immunology
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The revision rate within the first four postoperative weeks between treatment with standard therapy (OPsite patch) and study therapy (PICO) should be examined. During the clinical stay after the operation, the dressing is examined every day until discharge. Wound healing is clinically observed and recorded. In addition to the laboratory chemical infection parameters (CRP, leukocyte count), clinical signs of infection such as increased secretion are recorded. If there is a wound healing disorder or infection, wound management and microbiology is included in the subsequent treatment and a treatment strategy is developed and initiated together. In the event of a physiological wound healing process and other freedom from symptoms, the patients are discharged as usual.<br>Four weeks postoperatively, participants are contacted once by telephone and asked about the current status of wound healing.
- Secondary Outcome Measures
Name Time Method ogistic regression for the outcome Revision is planned as a further secondary analysis.