Extremity boards for process optimization, evaluation, risk minimization and therapy optimization for fractures with soft tissue damage or post-operative infection of the lower extremities in the trauma network

Not Applicable

Recruiting

Conditions: S71.87
S71.88
S71.89
S81.87
S81.88
S91.88
S78
S88
S98
T84.6

Registration Number: DRKS00031308

Lead Sponsor: niversitätsklinikum Münster, Klinik für Unfall-, Hand- und Wiederherstellungschirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 3366

Inclusion Criteria

Patients who meet at least one of the following two criteria:
- Fractures of the extremities with open soft tissue damage (according to Gustilo-Anderson)
or
- postoperative complications (according to the criteria of the AO Anti-Infection Task Force) or unplanned re-operation within 6 months after initial surgery

These criteria are operationalized via the ICD-10 codes for:
- Open soft tissue damage during fractures or dislocations as well as amputations of the lower limb
- Lower limb infections (excluding joints and joint endoprostheses):
- Infections of joints and/or joint endoprostheses of the lower extremity:
- Pseudarthrosis and delayed fracture healing of the lower limb

The following prerequisites must also be met:
- Consent to study participation and data transfer
- Legal capacity to consent to study participation
- Statutory health insurance

Exclusion Criteria

Patients who meet both of the following criteria:
- No fracture of the extremities or closed fracture of the extremities without open soft tissue damage
and
- No postoperative complication or unplanned re-operation within 6 months after initial surgery

Formal criteria
- Lack of consent to study participation and data transfer
- Unclear legal / consent capacity
- Not covered by statutory health insurance

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Either the occurrence or non-occurrence of complications is observed (dichotomous variables). The following events are considered complications if they occur within 6 months of the trauma: <br>• Occurrence of pseudarthrosis (incomplete fracture healing)<br>• Occurrence of chronic osteomyelitis<br>• Unplanned follow-up procedures such as wound revisions, NPWT, etc.<br>• deviation from the standardized antibiotic therapy (extension of the duration of therapy, change or extension of the active ingredient), <br>• Occurrence of antibiotic-associated complications (e.g., clostridial infection, allergy, etc.)<br>• Infection with resistant germs (e.g., MRSA) that occurred during inpatient treatment and did not exist at the time of trauma<br>• Need for unplanned inpatient treatment<br>• Death of the patient related to the trauma (not due to other causes)<br>

Secondary Outcome Measures

Name	Time	Method
Medidal, secondary outcomes<br>• Number of antibiotics applied<br>• Functioning of the extremities<br>• Health-related quality of life (HRQoL)<br>• Measured by survey instrumentse VR-36 and EQ-5D<br><br>Health economical outcomes:<br>• Use of health services<br>• Cost of healthcare services<br>• Inability to work (in days)<br>• Sick pay days<br><br>Work-related outcomes:<br>• workload<br>• job satisfaction (ressources and demands)<br>• technology readiness / acceptance<br>• IT ergonomics (intervention group, only)<br>