Evidence map›Paper›PMID 37101230›Full record

ArticlePatient safety in surgery2023

Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study.

Hae Sung Kang, Jad Khoraki, Jessie Gie, Dielle Duval, Susan Haynes, Michael Siev, Jay Shah, Fernando Kim, Martin Mangino, Levi Procter and 2 more

Open access · goldAbstract read
In one paragraph

Article in Patient safety in surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

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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

12 authors at 6 institutions in 1 country.

Hae Sung KangDepartment of Surgery, Virginia Commonwealth University Health, Richmond, VA, USA.
Jad KhorakiDepartment of Surgery, Virginia Commonwealth University Health, Richmond, VA, USA.
Jessie GieDepartment of Urology, Stanford Health, Palo Alto, CA, USA.
Dielle DuvalDepartment of Urology, Graves Gilbert Clinic, Bowling Green, KY, USA.
Susan HaynesDepartment of Surgery, Virginia Commonwealth University Health, Richmond, VA, USA.
Michael SievDepartment of Urology, Yale School of Medicine, New Haven, CT, USA.
Jay ShahDepartment of Urology, Stanford Health, Palo Alto, CA, USA.
Fernando KimDepartment of Urology, University of Colorado, Denver, CO, USA.
Martin ManginoDepartment of Surgery, Virginia Commonwealth University Health, Richmond, VA, USA.
Levi ProcterDepartment of Surgery, Virginia Commonwealth University Health, Richmond, VA, USA.
Riccardo AutorinoDepartment of Surgery, Virginia Commonwealth University Health, Richmond, VA, USA.
Samuel WeprinNew Jersey Urology, Summit Health, Cherry Hill, NJ, USA. Weprin.sam@gmail.com.
Virginia Commonwealth University · USStanford Health Care · USGraves Gilbert Clinic · USNew Jersey Urology · USUniversity of Colorado Denver · USYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRetained surgical sharps (RSS) is a "never event" that is preventable but may still occur despite of correct count and negative X-ray. This study assesses the feasibility of a novel device ("Melzi Sharps Finder®" or MSF) in effective detection of RSS.

methodsThe first study consisted of determination of the presence of RSS or identification of RSS in an ex-vivo model (a container with hay in a laparoscopic trainer box). The second study consisted of determining presence of RSS in an in-vivo model (laparoscopy in live adult Yorkshire pigs) with 3 groups: C-arm, C-arm with MSF and MSF. The third study used similar apparatus though with laparotomy and included 2 groups: manual search and MSF.

resultsIn the first study, the MSF group had a higher rate of identification of a needle and decreased time to locate a needle versus control (98.1% vs. 22.0%, p < 0.001; 1.64 min ± 1.12vs. 3.34 min ± 1.28, p < 0.001). It also had increased accuracy of determining the presence of a needle and decreased time to reach this decision (100% vs. 58.8%, p < 0.001; 1.69 min ± 1.43 vs. 4.89 min ± 0.63, p < 0.001). In-the second study, the accuracy of determining the presence of a needle and time to reach this decision were comparable in each group (88.9% vs. 100% vs. 84.5%, p < 0.49; 2.2 min ± 2.2 vs. 2.7 min ± 2.1vs. 2.8 min ± 1.7, p = 0.68). In the third study, MSF group had higher accuracy in determining the presence of a needle and decreased time to reach this decision than the control (97.0% vs. 46.7%, p < 0.001; 2.0 min ± 1.5 vs. 3.9 min ± 1.4; p < 0.001). Multivariable analysis showed that MSF use was independently associated with an accurate determination of the presence of a needle (OR 12.1, p < 0.001).

conclusionsThe use of MSF in this study's RSS models facilitated the determination of presence and localization of RSS as shown by the increased rate of identification of a needle, decreased time to identification and higher accuracy in determining the presence of a needle. This device may be used in conjunction with radiography as it gives live visual and auditory feedback for users during the search for RSS.

Indexed as

Melzi Sharps FinderNever eventPatient safetyRetained surgical sharps

Identifiers

PMID37101230
PMCPMC10131432
OpenAlexW4367052038

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.