Intraoperative wound irrigation to prevent surgical site infection afterlaparotomy

Phase 1

• Conditions: To investigate whether the use of intraoperative, epifascial woundirrigation with polyhexanide (PHX) solution can reduce surgical siteinfections (SSI) after laparotomy for visceral surgery compared to salineirrigation or no irrigation.

• Registration Number: EUCTR2017-000152-26-DE
• Lead Sponsor: Technische Universität München Fakultät für Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-26
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

•Clean-contaminated, contaminated or dirty surgery according to Centre for Disease Control (CDC) classification;
•Abdominal surgery by midline or transverse laparotomy; 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;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

•Pregnancy or breast feeding;
•Known hypersensitivity/allergy to PHX;
•Inability to understand/give informed consent;
•ASA >3;
•Critical medical condition of emergency patients, precluding informed consent or sufficient time to reflect on the decision to participate in the trial
•Inability to attend follow-up visits;
•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;
•Concurrent abdominal wall infections;
•Pre-operative antibiotic therapy (within 5 days prior to surgery) except for emergencies due to septic peritonitis
•Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether the use of intraoperative, epifascial wound irrigation with polyhexanide (PHX) solution can reduce surgical site infections after laparotomy for visceral surgery compared to saline irrigation or no irrigation.;Secondary Objective: not applicable;Primary end point(s): SSI according to CDC criteria within 30 days postoperatively;Timepoint(s) of evaluation of this end point: 30 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Non-infectious wound complications (e.g. seroma, hematoma, delayed healing) within 30 days postoperatively<br>•Duration of hospital stay<br>•Mortality and morbidity within 30 days postoperatively<br>•Incidence of reoperation within 30 days postoperatively<br>•Incidence of AE/SAE within 30 days postoperatively<br>;Timepoint(s) of evaluation of this end point: 30 days