Evidence map›Paper›PMID 40512393›Full record

Trial reportLangenbeck's archives of surgery2025

Chlorhexidine - coated vs non-coated Suture to prevent surgical site infections following laparoscopic abdominal surgery (a prospective, randomized, controlled trial; NOVOTILAC).

Markus T Golling, Viktor Breul, Susan Barongo, Toni Milosheski, Javier Corral Rubio, Alba Zárate Pinedo, Carlos Hoyuela, Nils Jimmy Hidalgo, Wolfgang Steurer, Petra Baumann

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyComparative Study
In one paragraph

Trial report in Langenbeck's archives of surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04033211 (Randomized, Multi-center, Double Blinded, Prospective Study to Evaluate the Incidence of Complications in Laparoscopic Cholecystectomy and Appendectomy Using Novosyn® CHD Versus Novosyn® Suture Material to Close Trocar Wound), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT04033211 completednot on this map

Randomized, Multi-center, Double Blinded, Prospective Study to Evaluate the Incidence of Complications in Laparoscopic Cholecystectomy and Appendectomy Using Novosyn® CHD Versus Novosyn® Suture Material to Close Trocar Wound

TypeobservationalSponsorAesculap AGRan2020 to 2023Enrolled316ConditionsAppendicitis, CholecystitisArmsNovosyn® CHD for fascia and skin closure, Novosyn® for fascia and skin closure
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

10 authors.

Markus T GollingDepartment of General & Visceral Surgery, DIAK/DIAKONEO, Schwaebisch Hall, Germany. markus.golling@diakoneo.de.
Viktor BreulAesculap AG, Department Medical Scientific Affairs, Am Aesculap Platz, Tuttlingen, Germany.
Susan BarongoDepartment of General & Visceral Surgery, DIAK/DIAKONEO, Schwaebisch Hall, Germany.
Toni MilosheskiDepartment of General Surgery, Krankenhaus Leonberg, Leonberg, Germany.
Javier Corral RubioDepartment of General Surgery, Hospital Germans Trias i Pujol, Badalona, Spain.
Alba Zárate PinedoDepartment of General Surgery, Hospital Germans Trias i Pujol, Badalona, Spain.
Carlos HoyuelaDepartment of General Surgery, Hospital Plató, Barcelona, Spain.
Nils Jimmy HidalgoDepartment of General Surgery, Hospital Plató, Barcelona, Spain.
Wolfgang SteurerDepartment of General Surgery, Krankenhaus Leonberg, Leonberg, Germany.
Petra BaumannAesculap AG, Department Medical Scientific Affairs, Am Aesculap Platz, Tuttlingen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSurgical site infection (SSI) is the second most frequently reported health-care related infection and is accompanied by significant morbidity and considerable costs. Since cutaneous, bacterial contamination plays an important role, antimicrobial coated threads may - amongst other measures - reduce or prevent SSI.

methodThis international, multicentric, parallel, double-blinded prospective, randomized, controlled trial (RCT) evaluated a new Chlorhexidine-(CHD) coated braided suture material ([Poly(glycolid-co-l-lactid 90/10)]; PGL-CHD) in comparison to the identical non-coated suture material (PGL) to close trocar incisions in patients undergoing laparoscopic appendectomy or cholecystectomy for the prevention of SSI. Primary endpoint was the incidence of SSI one month after surgery. Secondary outcomes were postoperative pain, suture material handling, length of hospital stay, quality of life, aesthetic result and the postoperative complication rate including hernias. Randomization was performed intra-operatively using sealed opaque envelopes. The patient was blinded to the type of suture material & the observer who was involved in the postsurgical wound assessment. Patients were followed up until 12 months after surgery.

resultsIn total, 337 patients were enrolled, 323 randomized, whereby 161 cases received PGL-CHD & 162 PGL suture material. One month follow-up examination was completed in 297 individuals. SSI rate in the whole population was 5%. In total 10 SSI occurred in the uncoated suture group (10/162; 95%CI: 6.17% [3.26-11.12%]) and 6 in the coated group (6/158; 95% CI: 3.79% [1.57-8.22%]), p = 0.44. Surgical handling of both suture materials was rated as very good and the pain level decreased from preoperative to postoperative and patients were pain-free 30 days after surgery. The long-term follow-up showed an excellent cosmetic assessment of the wound by the patient as well as by the observer, and an improvement of quality of life over time with no difference in the various suture and indication groups. The overall 1 year hernia rate was low with 0.9%, mean length of hospital stay was reported with 2.90 ± 2.29 days and only a few patients (6/323) were admitted to ICU.

conclusionThe SSI rate in the CHD-coated suture group compared to the uncoated group was lower, but failed to reach significance.

Indexed as

Anti-Infective Agents, LocalAppendectomyChlorhexidineCholecystectomy, LaparoscopicCoated Materials, BiocompatibleLaparoscopySurgical Wound InfectionSuturesAdultAgedDouble-Blind MethodFemaleHumansLength of StayMaleMiddle AgedAnti-Infective Agents, LocalChlorhexidineCoated Materials, BiocompatibleChlorhexidineProspectiveRandomized controlled trialSurgical site infectionSuture

Identifiers

PMID40512393
PMCPMC12165995

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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.