Elective SurgeryPhase 3BALGDECNCT05647252
General Decolonization With Octenisan® Set Before Elective Orthopedic Surgery
A Phase 3 study testing Whole Body and nasal decolonization with octenidin (Octenisan Set) and Questionnaire for study participants immediately after the decolonization in people with Elective Surgery and High Risk, run by Balgrist University Hospital at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgery, High Risk, Prevention of Surgical Site Infections
- What is being tested?
- Whole Body and nasal decolonization with octenidin (Octenisan Set) and Questionnaire for study participants immediately after the decolonization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,086 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 27 Feb 2023to 20 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Balgrist University Hospital
Zurich
About this study
Official title: General Skin and Nasal Decolonization With Octenisan® Set Be-fore and After Elective Orthopedic Surgery in Selected Patients at Elevated Risk for Revision Surgery and Surgical Site Infections
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
Read the detailed description
The general decolonization of the human body surface and, of adjacent pathogen reservoirs such as the nose, by industrial antiseptic agents by the World Health Organization (WHO) for the risk reduction of superficial and deep surgical site infection (SSI). Such a decolonization is regarded as evidence-based in the majority of randomized, and before-after trials, since two decades, although negative studies also exist.
In the orthopedic field, this decolonization is likely to be more effective in elective patients with a proven body colonization of Staphylococcus aureus. The decolonization might be equally efeective in orthopedic patients with an inherent high risk for SSI, for which the majority of future SSI pathogens are skin commensals and S. aureus. These (eventual and future) pathogens of SSI are accessible to the topical agents during the index surgery, if the patients are well instructed and know how to decolonize themselves.
In contrast, this pre-surgical decolonization is only a supplementary measure in the bundle of all combined efforts to prevent revision surgery for infection. Its individual power is limited for young, healthy individuals, for SSIs caused by pathogens from the internal body sites (intestinal, urinary, gynecologic regions), infections acquired on the surgical ward, and in settings with less specialized surgeries and a low volume of surgical experience. Hence, in trials including all patients (or only those carrying S. aureus), the beneficial effect of decolonization can be diluted and provoke an additional costly and cumber-some organizational procedure for the majority of patients with low to moderate SSI risks.
Moreover, many surgical site infections in orthopedic surgery, especially in implant-related surgery, are more due to coagulase-negative staphylococci (CoNS) than for S. aureus.
The hallmark of the CoNS group is S. epidermidis with approximatively 70% resistance (in Switzerland) to standard prophylactic antibiotic agents9, As S. epidermidis is part of the normal human flora, typically the skin flora, and, only becomes pathogenic under certain conditions, a screening for this microorganism is not feasible in common practice,. while the prophylaxis-resistant part of all orthopedic SSI pathogens is at 30-50%.
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 sur-gery and SSI; inde-pendently of a known body carriage for S. aureus.
This study will be performed with an existing "set" manufactured by Schülke \& Mayr GmbH. The "Set" was placed on the market in 2016. The distribution of Octenisan® wash lotion and Octenisan® nasal gel in the form of a set (Octenisan® Set) largely streamlines and facilitates the organizational application and compliance efforts of the study.
Academically and clinically, we will gain insight in the performance of decolonization for a patient population at particular risk of postoperative complications, where every effort to prevent infection is of importance.
- Conditions
- Elective Surgery, High Risk, Prevention of Surgical Site Infections, Randomized-controlled Trial
- Being tested
- Whole Body and nasal decolonization with octenidin (Octenisan Set), Questionnaire for study participants immediately after the decolonization
- Keywords
- Body and nasal decolonization, Adult orthopedic surgery, Prevention of Surgical Site Infections, Randomized-controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Questionnaire for study participants immediately after the decolonizationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission (and inversely surgical site infection)
Remission is defined as the absence of clinical, anamnestic, radiologic or laboratory signs of infection.
Measured: 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
Measured: Until week 6 after surgery
Secondary outcomes (3)
Unplanned revision surgery for non-infection problems in same time period
Any revision in the operating theatre due to non-infectious pathologies
Measured: At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants
Adverse events
All adverse events during the decolonization and hospitalization periods
Measured: At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants
Subjective opinion and information on the decolonization
Questionnaire with 5 questions only for patients being decolonized
Measured: A day within one week after surgery (during the hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start27 Feb 2023
- Primary completion28 Nov 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Elective SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-Center, Unblinded, Superiority, Randomized-Controlled Trial (Randomization 1:1)
- Masking
- None (open label)
- Enrolment
- 1,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Industry (Schülke & Mayr AG, Switzerland and Germany)
- Responsible party
- Principal investigator, Ilker Uckay, Balgrist University Hospital
- Investigators
- Ilker Uçkay, Prof., Principal investigator, Balgrist University Hospital, Zürich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647252
- Sponsor's protocol ID
- Prov. Wissenschaftsantrag 980
- Acronym
- BALGDEC
- Status last verified
- Feb 2025
- First submitted
- 30 Nov 2022
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Study Protocol will be published separately The results of the study will be a publication
Publications
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.
PubMed 23414705Tsang 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.
PubMed 29671723Dancer 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.
PubMed 27601492Prentice 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.
PubMed 36084332Rohrer 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.
PubMed 32058435Unterfrauner 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.
PubMed 38978089
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Skin and Nasal Decolonization With Octenisan® Set Be-fore and After Elective Orthopedic Surgery in Selected Patients at Elevated Risk for Revision Surgery and Surgical Site Infections
- ClinicalTrials.gov ID
- NCT05647252
- Acronym / sponsor ID
- BALGDEC / Prov. Wissenschaftsantrag 980
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,086 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Industry (Schülke & Mayr AG, Switzerland and Germany)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The general decolonization of the human body surface and, of adjacent pathogen reservoirs such as the nose, by industrial antiseptic agents by the World Health Organization (WHO) for the risk reduction of superficial and deep surgical site infection (SSI). Such a decolonization is regarded as evidence-based in the majority of randomized, and before-after trials, since two decades, although negative studies also exist.
In the orthopedic field, this decolonization is likely to be more effective in elective patients with a proven body colonization of Staphylococcus aureus. The decolonization might be equally efeective in orthopedic patients with an inherent high risk for SSI, for which the majority of future SSI pathogens are skin commensals and S. aureus. These (eventual and future) pathogens of SSI are accessible to the topical agents during the index surgery, if the patients are well instructed and know how to decolonize themselves.
In contrast, this pre-surgical decolonization is only a supplementary measure in the bundle of all combined efforts to prevent revision surgery for infection. Its individual power is limited for young, healthy individuals, for SSIs caused by pathogens from the internal body sites (intestinal, urinary, gynecologic regions), infections acquired on the surgical ward, and in settings with less specialized surgeries and a low volume of surgical experience. Hence, in trials including all patients (or only those carrying S. aureus), the beneficial effect of decolonization can be diluted and provoke an additional costly and cumber-some organizational procedure for the majority of patients with low to moderate SSI risks.
Moreover, many surgical site infections in orthopedic surgery, especially in implant-related surgery, are more due to coagulase-negative staphylococci (CoNS) than for S. aureus.
The hallmark of the CoNS group is S. epidermidis with approximatively 70% resistance (in Switzerland) to standard prophylactic antibiotic agents9, As S. epidermidis is part of the normal human flora, typically the skin flora, and, only becomes pathogenic under certain conditions, a screening for this microorganism is not feasible in common practice,. while the prophylaxis-resistant part of all orthopedic SSI pathogens is at 30-50%.
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 sur-gery and SSI; inde-pendently of a known body carriage for S. aureus.
This study will be performed with an existing "set" manufactured by Schülke \& Mayr GmbH. The "Set" was placed on the market in 2016. The distribution of Octenisan® wash lotion and Octenisan® nasal gel in the form of a set (Octenisan® Set) largely streamlines and facilitates the organizational application and compliance efforts of the study.
Academically and clinically, we will gain insight in the performance of decolonization for a patient population at particular risk of postoperative complications, where every effort to prevent infection is of importance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-Center, Unblinded, Superiority, Randomized-Controlled Trial (Randomization 1:1)
| Arm | Type | Receives |
|---|---|---|
| Decolonization | Experimental | Drug: Whole Body and nasal decolonization with octenidin (Octenisan Set), Behavioral: Questionnaire for study participants immediately after the decolonizationThis 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. |
| Non-Decolonization | No intervention | –No Decolonization preoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Decolonization |
| Questionnaire for study participants immediately after the decolonizationA 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. | Behavioural | Decolonization |
Primary outcome
Remission (and inversely surgical site infection)
Time frame: At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants
Remission is defined as the absence of clinical, anamnestic, radiologic or laboratory signs of infection.
Wound problems after elective surgery
Time frame: Until week 6 after surgery
Wound problems (dehiscence, seroma, hematoma, necrosis) occurring after surgery
3 secondary outcomes
Unplanned revision surgery for non-infection problems in same time period
Time frame: At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants
Adverse events
Time frame: At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants
Subjective opinion and information on the decolonization
Time frame: A day within one week after surgery (during the hospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Results publication: PubMed 23414705Uckay 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.
- Results publication: PubMed 29671723Tsang 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.
- Results publication: PubMed 27601492Dancer 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.
- Results publication: PubMed 36084332Prentice 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.
- Results publication: PubMed 32058435Rohrer 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.
- Derived from this study: PubMed 38978089Unterfrauner 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.
- Octenidin Set (Manufacturer's information)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The Study Protocol will be published separately The results of the study will be a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilker Uçkay, Prof. principal investigator
Balgrist University Hospital, Zürich, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Whole Body and nasal decolonization with octenidin (Octenisan Set) and Questionnaire for study participants immediately after the decolonization in people with Elective Surgery and High Risk, run by Balgrist University Hospital at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission (and inversely surgical site infection) (time frame: At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647252, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.