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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00028037

Enrollment

232

Registered

2022-05-27

Start date

2022-09-17

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T81.4 T81.3

Interventions

Group 1: Prophylactic peritoneal irrigation with 1000ml NaOCl/HOCl (50/50ppm) solution before closure of the abdominal fascia, subcutaneous wound irrigation with another 500ml of the solution after cl

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the trial is the SSI rate within 30 days postoperatively	—

Secondary

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

Countries

Germany

Contacts

Public ContactTara Müller

Chirurgisches StudienzentrumKlinikum Rechts der IsarTechnische Universität München

tara.mueller@tum.de00498941402180

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 12, 2026