Evidence map›Paper›PMID 38978089›Full record

ArticleTrials2024

General skin and nasal decolonization with octenisan® 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).

Ines Unterfrauner, Nadja Bragatto-Hess, Thorsten Studhalter, Mazda Farshad, Ilker Uçkay

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05647252 (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), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05647252 phase3completednot on this map

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

TypeinterventionalSponsorBalgrist University HospitalRan2023 to 2025Enrolled1,086ConditionsElective Surgery, High Risk, Prevention of Surgical Site Infections, Randomized-controlled TrialArmsWhole Body and nasal decolonization with octenidin (Octenisan Set), Questionnaire for study participants immediately after the decolonization
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Ines UnterfraunerOrthopedic Surgery, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.
Nadja Bragatto-HessInfection Control, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.
Thorsten StudhalterInfection Control, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.
Mazda FarshadOrthopedic Surgery, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.
Ilker UçkayInfection Control, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland. ilker.uckay@balgrist.com.ORCID http://orcid.org/0000-0002-5552-0973

Funding

Schülke & Mayr AG W990
6 · The paper itself

Abstract

backgroundThe preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature.

methodsWe perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3-4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2-3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. DISCUSSION: In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI.

trial registrationClinicalTrial.gov NCT05647252. Registered on 9 December 2022. PROTOCOL VERSION: 2 (5 December 2022).

Indexed as

Anti-Infective Agents, LocalElective Surgical ProceduresOrthopedic ProceduresReoperationSurgical Wound InfectionAged, 80 and overEquivalence Trials as TopicFemaleHumansIminesMalePreoperative CarePyridinesRisk FactorsSkinTreatment OutcomeAnti-Infective Agents, LocalIminesoctenidinePyridinesBody decolonizationElective orthopedic surgeryHigh risk patientsOctenidineQuestionnaireRandomized controlled trialSurgical site infectionsWound problems

Identifiers

PMID38978089
PMCPMC11229206

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.