To investigate whether the use of intraoperative, epifascial wound irrigation with polyhexanide (PHX) solution can reduce surgical site infections (SSI) after laparotomy for visceral surgery compared to saline irrigation or no irrigation.
Conditions
Interventions
Pharmaceutical Form: Irrigation solution
INN or Proposed INN: POLIHEXANIDE
CAS Number: 32289-58-0
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceuti
Sponsors
Technische Universität München Fakultät für Medizin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Non-infectious wound complications (e.g. seroma, hematoma, delayed healing) within 30 days postoperatively • Duration of hospital stay • Mortality and morbidity within 30 days postoperatively • Incidence of reoperation within 30 days postoperatively • Incidence of AE/SAE within 30 days postoperatively ;Timepoint(s) of evaluation of this end point: 30 days | — |
Countries
Germany
Contacts
Public ContactKlinik und Poliklinik für Chirurgie
Technische Universität München Klinikum rechts der Isar
Outcome results
None listed