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General Decolonization With Octenisan® Set Before Elective Orthopedic Surgery

NCT05647252 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1086

Last updated 2025-02-21

No results posted yet for this study

Summary

The general decolonization of the human body surface by industrial antiseptic agents, before elective surgery is recommended by the World Health Organization (WHO).

A specific randomized-controlled trial specifically among high-risk adult orthopedic patients for infection has not been performed.

In this single-center, prospective, randomized, and controlled superiority trial, which is planned over a period of two years, we target on an orthopedic patient population with an elevated risk for revision surgery and surgical site infections

Conditions

  • Elective Surgery
  • High Risk
  • Prevention of Surgical Site Infections
  • Randomized-controlled Trial

Interventions

DRUG

Whole Body and nasal decolonization with octenidin (Octenisan Set)

Octenidin body lotion once a day during the five consecutive days preceding the elective orthopedic surgery, including for the hair. Octenidin nasal creme 2-3 times a day in both nasal orifices during the same period

BEHAVIORAL

Questionnaire for study participants immediately after the decolonization

A questionnaire in GErman language will be handed out to decolonized patients with five questions: Practical difficulties of decolonization, the completeness of scheduled decolonization actions, all adverse events during decolonization and surgery, and two questions regarding the comprehension of the science (indication for decolonization, potential benefit expected in the individual case). The questionnaire is handmade and validated by the Investigators.

Sponsors & Collaborators

  • Industry (Schülke & Mayr AG, Switzerland and Germany)

    collaborator UNKNOWN

  • Balgrist University Hospital

    lead OTHER

Principal Investigators

  • Ilker Uçkay, Prof. · Balgrist University Hospital, Zürich, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-27
Primary Completion
2024-11-28
Completion
2025-02-20

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05647252 on ClinicalTrials.gov