Peritoneal antiseptic irrigation to prevent surgical site infection after laparotomy for hepatobiliary or gastrointestinal surgery

Not Applicable

Recruiting

Conditions: T81.4
T81.3
Infection following a procedure, not elsewhere classified
Disruption of operation wound, not elsewhere classified

Registration Number: DRKS00028037

Lead Sponsor: Chirurgisches Studienzentrum Klinik und Poliklinik für ChirurgieKlinikum Rechts der IsarTechnische Universität München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 232

Inclusion Criteria

• Clean-contaminated, contaminated or dirty surgery according to CDC classification;
• Abdominal surgery by midline or transverse laparotomy for hepatobiliary or gastrointestinal resections; elective and emergency procedures;
• Age = 18 years;
• American Society of Anesthesiologists (ASA) score = 3;
• Ability to understand the nature and extent of the trial and to give written informed consent

Exclusion Criteria

• Inability to give/understand informed consent;
• ASA > 3;
• Incompliance to adhere to the follow-up visit schedule or telephone interview;
• Clean procedures according to the CDC classification or surgery without opening of the abdominal cavity;
• Laparoscopic surgery;
• Revision-surgery (previous abdominal surgery within the last 30 days);
• Planned re-laparotomy within 30 days;
• Severe immunosuppression;
• Terminal kidney failure requiring dialysis;
• Concurrent abdominal wall infections;
• Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the trial is the SSI rate within 30 days postoperatively

Secondary Outcome Measures

Name	Time	Method
a) Rate of SSI by CDC grade I-III (superficial, deep, organ-space) (%)<br>b) Duration of hospital stay up to 30 days after surgery (days); <br>c) 30-days mortality and morbidity (%);<br>d) 30-days rate of reoperation/relaparotomy (%);<br> <br>