Reduction of Postoperative Wound Infections by Antiseptica?

Phase 3

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: Polihexanide; Serasept; Drug: NaCl; saline

• Registration Number: NCT04055233
• Lead Sponsor: Johannes Lauscher

Brief Summary

Wound infections are a frequent complication in abdominal surgery. The investigators hypothesize that the antiseptic solution 0.04 % polyhexanide (serasept) may reduce occurrence of postoperative wound infections compared to NaCL (saline) solution in a prospective randomized setting.

Detailed Description

Invstigator initiated monocenter randomized controlled trial. Intraoperative irrigation of subcutaneous tissue with NaCl (saline) solution or antiseptic solution 0.04 % polyhexanide (Serasept) in elective abdominal surgery. Primary endpoint: SSI 30 days postoperatively according to CDC criteria.

Study Timeline

• Study Start: 2015-02-01
• Study First Submitted: 2018-04-25
• Primary Completion: 2018-09-10
• Study Completion: 2018-10-20
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-12
• Last Update Submitted: 2019-08-12
• Study First Posted: 2019-08-13
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

• planned laparotomy for visceral surgery

Exclusion Criteria

• Age under 18 years
• allergy against polihexanid
• laparoscopic surgery
• emergency surgery
• lack of understanding of the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcutaneous irrigation with 0.04% polyhexanide solution	Polihexanide; Serasept	Intervention: after closure of abdominal fascia, an intraoperative irrigation of the subcutaneous tissue with 250 ml antiseptic solution (0.04% polyhexanide) will be done once for ten minutes. No subcutaneous suture. Closure of skin with either staples, interrupted sutures or running suture.
Subcutaneous irrigation with NaCl (saline)	NaCl; saline	Intervention: after closure of fascia, an intraoperative irrigation of the subcutaneous tissue with 250 ml NaCl (saline) will be done once for one minute. No subcutaneous suture. Closure of skin with either staples, interrupted sutures or running suture.

Primary Outcome Measures

Name	Time	Method
surgical site infection	30 days postoperatively	Surgical site infection according to CDC definition.

Trial Locations

Locations (1)

Charité Campus Benjamin Franklin; 🇩🇪 Berlin-Steglitz, Berlin, Germany