Evidence map›Paper›PMID 28155060›Full record

Trial reportJournal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology2017

Fast-resorbable antibiotic-loaded hydrogel coating to reduce post-surgical infection after internal osteosynthesis: a multicenter randomized controlled trial.

Kostantinos Malizos, Michael Blauth, Adrian Danita, Nicola Capuano, Riccardo Mezzoprete, Nicola Logoluso, Lorenzo Drago, Carlo Luca Romanò

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 5 pooled it
10.7field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 5 syntheses or guidelines pooled it, 118 citations in OpenAlex.

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  13. DACBiomedicines · 2025
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1 more citing papers are in PubMed but not listed here.

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

8 authors at 4 institutions in 3 countries.

Kostantinos MalizosOrthopaedic Surgery and Trauma, Medical School, University of Thessaly, Larissa, Greece.
Michael BlauthDepartment for Trauma Surgery, Medical University, Innsbruck, Austria.
Adrian DanitaDepartment for Trauma Surgery, Medical University, Innsbruck, Austria.
Nicola CapuanoDepartment for Orthopaedics, San Luca Hospital, Vallo Della Lucania, Italy.
Riccardo MezzopreteDepartment for Orthopaedics, San Camillo de Lellis Hospital, Rieti, Italy.
Nicola LogolusoDepartment of Reconstructive Surgery of Osteo-articular Infections CRIO Unit, IRCCS Galeazzi Orthopaedic Institute, Via R. Galeazzi 4, 20161, Milan, Italy.
Lorenzo DragoLaboratory of Clinical Chemistry and Microbiology, IRCCS Galeazzi Orthopaedic Institute, Milan, Italy.
Carlo Luca RomanòDepartment of Reconstructive Surgery of Osteo-articular Infections CRIO Unit, IRCCS Galeazzi Orthopaedic Institute, Via R. Galeazzi 4, 20161, Milan, Italy. carlo.romano@grupposandonato.it.
Innsbruck Medical University · ATIstituto Ortopedico Galeazzi · ITUniversity of Milan · ITUniversity of Thessaly · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfection is one of the main reasons for failure of orthopedic implants. Antibacterial coatings may prevent bacterial adhesion and biofilm formation, according to various preclinical studies. The aim of the present study is to report the first clinical trial on an antibiotic-loaded fast-resorbable hydrogel coating (Defensive Antibacterial Coating, DAC MATERIALS AND

methodsIn this multicenter randomized controlled prospective study, a total of 256 patients in five European orthopedic centers who were scheduled to receive osteosynthesis for a closed fracture, were randomly assigned to receive antibiotic-loaded DAC or to a control group (without coating). Pre- and postoperative assessment of laboratory tests, wound healing, clinical scores and X-rays were performed at fixed time intervals.

resultsOverall, 253 patients were available with a mean follow-up of 18.1 ± 4.5 months (range 12-30). On average, wound healing, clinical scores, laboratory tests and radiographic findings did not show any significant difference between the two groups. Six surgical site infections (4.6%) were observed in the control group compared to none in the treated group (P < 0.03). No local or systemic side-effects related to the DAC hydrogel product were observed and no detectable interference with bone healing was noted.

conclusionsThe use of a fast-resorbable antibiotic-loaded hydrogel implant coating provides a reduced rate of post-surgical site infections after internal osteosynthesis for closed fractures, without any detectable adverse event or side-effects. LEVEL OF EVIDENCE: 2.

Indexed as

AdultAgedAged, 80 and overAnti-Bacterial AgentsCoated Materials, BiocompatibleDrug CombinationsEuropeFemaleFollow-Up StudiesFracture Fixation, InternalFractures, ClosedHumansHydrogelsIncidenceMaleMiddle AgedAnti-Bacterial AgentsCoated Materials, BiocompatibleDrug CombinationsHydrogelsCoatingDACHydrogelInfectionOsteosynthesisPrevention

Identifiers

PMID28155060
PMCPMC5429256
OpenAlexW2584049517

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.