General Decolonization With Octenisan® Set Before Elective Orthopedic Surgery

NCT05647252 | Completed Phase 3 DMC

• 1 other identifier: Prov. Wissenschaftsantrag 980
• Study Type: interventional
• Target: 1,086
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Body and nasal decolonization; Adult orthopedic surgery; Prevention of Surgical Site Infections; Randomized-controlled trial

Outcome Measures

Primary Outcomes (2)

• Remission (and inversely surgical site infection)

  Remission is defined as the absence of clinical, anamnestic, radiologic or laboratory signs of infection.

  At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants

• Wound problems after elective surgery

  Wound problems (dehiscence, seroma, hematoma, necrosis) occurring after surgery

  Until week 6 after surgery

Secondary Outcomes (3)

• Unplanned revision surgery for non-infection problems in same time period

  At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants

• Adverse events

  At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants

• Subjective opinion and information on the decolonization

  A day within one week after surgery (during the hospitalization)

Study Arms (2)

Decolonization

EXPERIMENTAL

This study will be performed with an existing "set" manufactured by Schülke \& Mayr GmbH. The distribution of octenisan® wash lotion and octenisan® nasal gel in the form of a set (octenisan® set) largely streamlines and facilitates the application and compliance. The duration of pre-surgical decolonization is planned to be five days. However, when this pre-surgical time period is too short, the decolonization may also start at least 3 days before surgery and be contin-ued up to 2 days post-surgery. During the post-surgery application, the patient will be washed with water and Octenisan® set by their treating nurses. The patient will also return the empty/used set and answer to a short questionnaire during their hospital stay. The study team will recuperate the questionnaire during hospitalization.

Drug: Whole Body and nasal decolonization with octenidin (Octenisan Set); Behavioral: Questionnaire for study participants immediately after the decolonization

Non-Decolonization

NO INTERVENTION

No Decolonization preoperatively

Interventions

Whole Body and nasal decolonization with octenidin (Octenisan Set) DRUG

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

Decolonization

Questionnaire for study participants immediately after the decolonization BEHAVIORAL

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.

Decolonization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients with an age ≥ 80 years (as considered particularly at risk for SSI)
• Elective orthopedic surgery at the Balgrist
• Chronic immune-suppression (diabetes mellitus, active cancer, cirrhosis CHILD C, renal dialysis, untreated HIV disease, medicamentous immune-suppression equivalent to prednisone ≥ 10 mg/day)
• Elective surgery in ischemic skin (e.g. major amputations)
• Elective surgery on non-diabetic and non-infected ulcerated skin
• Tumor (oncologic) orthopedic surgery
• ASA-Scores 3-4 points

You may not qualify if:

• Elective revision orthopedic surgery due to orthopedic infection within the last 12 months in the same area of surgery
• Emergency surgery (defined as planned surgery within the next 48 hours)
• Surgery on infected skin; or surgery under antibiotic treatment for any reason
• "Diabetic foot surgery" (distinct clinical entity; defined as below the ankle)
• Body mass index ≥ 35 kg/m2 (anticipated difficulty of effective decolonization)
• Pregnancy (formality reasons)
• Intolerance or allergy to octenidin and/or ingredients in the Octenisan® set
• Use of any other topical antiseptic agents other than Octenisan® set (except for the duration of one day)
• Patient unable to understand; or under legal guardian for medical decisions
• Anticipated clinical follow-up of less than 6 weeks after surgery.
• ASA-Scores 1-2, and ASA-Score 5 (high risk of postoperative complications)
• Known skin colonization with antibiotic-multiresistant Gram-negative organisms defined by infection control protocols of Switzerland1

Sponsors & Collaborators

• Balgrist University Hospital: lead
• Industry (Schülke & Mayr AG, Switzerland and Germany): collaborator

Study Sites (2)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

Balgrist University Hospital

Zurich, Switzerland

Location

Related Publications (6)

• Uckay I, Hoffmeyer P, Lew D, Pittet D. Prevention of surgical site infections in orthopaedic surgery and bone trauma: state-of-the-art update. J Hosp Infect. 2013 May;84(1):5-12. doi: 10.1016/j.jhin.2012.12.014. Epub 2013 Feb 14.

  PMID: 23414705 RESULT

• Tsang STJ, McHugh MP, Guerendiain D, Gwynne P, Boyd J, Laurenson IF, Templeton KE, Lewis S, Simpson AHRW, Walsh TS. Evaluation of Staphylococcus aureus eradication therapy in orthopaedic surgery. J Med Microbiol. 2018 Jun;67(6):893-901. doi: 10.1099/jmm.0.000731. Epub 2018 Apr 19.

  PMID: 29671723 RESULT

• Dancer SJ, Christison F, Eslami A, Gregori A, Miller R, Perisamy K, Robertson C, Graves N. Is it worth screening elective orthopaedic patients for carriage of Staphylococcus aureus? A part-retrospective case-control study in a Scottish hospital. BMJ Open. 2016 Sep 6;6(9):e011642. doi: 10.1136/bmjopen-2016-011642.

  PMID: 27601492 RESULT

• Prentice HA, Chan PH, Champsi JH, Clutter DS, Maletis GB, Mohan V, Namba RS, Reddy NC, Hinman AD, Fang AS, Yian E, Navarro RA, Norheim EP, Paxton EW. Temporal Trends in Deep Surgical Site Infections After Six Orthopaedic Procedures Over a 12-year Period Within a US-based Healthcare System. J Am Acad Orthop Surg. 2022 Nov 1;30(21):e1391-e1401. doi: 10.5435/JAAOS-D-22-00280. Epub 2022 Sep 7.

  PMID: 36084332 RESULT

• Rohrer F, Notzli H, Risch L, Bodmer T, Cottagnoud P, Hermann T, Limacher A, Fankhauser N, Wagner K, Brugger J. Does Preoperative Decolonization Reduce Surgical Site Infections in Elective Orthopaedic Surgery? A Prospective Randomized Controlled Trial. Clin Orthop Relat Res. 2020 Aug;478(8):1790-1800. doi: 10.1097/CORR.0000000000001152.

  PMID: 32058435 RESULT

• Unterfrauner I, Bragatto-Hess N, Studhalter T, Farshad M, Uckay I. General skin and nasal decolonization with octenisan(R) set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections-a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial). Trials. 2024 Jul 8;25(1):461. doi: 10.1186/s13063-024-08173-y.

  PMID: 38978089 DERIVED

Related Links

• Octenidin Set (Manufacturer's information)

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ilker Uçkay, Prof.

  Balgrist University Hospital, Zürich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr. med. Ilker Uçkay

Model Details: Single-Center, Unblinded, Superiority, Randomized-Controlled Trial (Randomization 1:1)

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 12, 2022
• Study Start: February 27, 2023
• Primary Completion: November 28, 2024
• Study Completion: February 20, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Before and after the study (February 2023 and May 2025)
• Access Criteria: Will be published in PubMed

Locations

CH (2)