Evidence map›Paper›PMID 32075685›Full record

ArticleTrials2020

Primary or secondary wound healing of the pin sites after removal of the external fixator: study protocol for a prospective, randomized controlled, monocenter trial.

Franz Roth, Flavio Cagienard, Björn C Link, Sandro Hodel, Dirk Lehnick, Reto Babst, Frank J P Beeres

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03842956 ("Wound Closure), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 32% 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.

NCT03842956 nacompletednot on this map

"Wound Closure (Allgower) Versus Secondary Open Wound Healing of the Pin Sites After Removal of the External Fixator: Study Protocol for a Prospective, Randomized Controlled Mono-center Trial"

TypeinterventionalSponsorLuzerner KantonsspitalRan2019 to 2021Enrolled241ConditionsInfection Rates Between Primary Wound-closure (Allgower) and Secondary Wound Healing After Removal of an External FixatorArmsPrimary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externe
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Observational
  2. Review
  3. Review
  4. 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

7 authors at 1 institution in 1 country.

Franz RothLucerne Cantonal Hospital, Orthopedic and Trauma Surgery, Lucerne, Switzerland. Franz.Roth@luks.ch.ORCID http://orcid.org/0000-0001-9960-0548
Flavio CagienardLucerne Cantonal Hospital, Orthopedic and Trauma Surgery, Lucerne, Switzerland.
Björn C LinkLucerne Cantonal Hospital, Orthopedic and Trauma Surgery, Lucerne, Switzerland.
Sandro HodelLucerne Cantonal Hospital, Orthopedic and Trauma Surgery, Lucerne, Switzerland.
Dirk LehnickClinical Trial Unit Central Switzerland and its Head of Biostatistics and Methodology, Lucerne, Switzerland.
Reto BabstLucerne Cantonal Hospital, Orthopedic and Trauma Surgery, Lucerne, Switzerland.
Frank J P BeeresLucerne Cantonal Hospital, Orthopedic and Trauma Surgery, Lucerne, Switzerland.
University of Lucerne · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTemporary fixation with an external fixator is used for numerous indications in orthopedic trauma surgery. It is unclear whether primary wound healing or secondary open-wound healing after removal of the external fixator should be advocated for the pin site. This study compares primary wound closure with secondary wound healing for the pin site. The primary aim is to compare pin-site infection rates. The secondary aim is to compare time to wound healing and esthetic outcome. The hypothesis was that primary wound closure does not lead to more infections than secondary wound healing. METHODS AND

designThis is a prospective, randomized controlled, blinded, monocenter study based on a non-inferiority design. To obtain an equal patient population and groups, all pin-entry sites of the patients are treated alternately at the time of removal of the external fixator with primary wound closure and secondary wound healing. Patients are randomized according to whether the proximal pin-entry site is treated with wound closure or by secondary open-wound healing, from which the further sequence develops. The pre- and postoperative protocol is standardized for all pin-entry sites. A photo documentation of the pin-entry sites takes place 2 and 52 weeks postoperatively during the routine clinical follow-up visits. Further controls take place at 6, 12 and 26 weeks after pin removal. The primary outcome was to demonstrate the non-inferiority of primary wound closure compared to secondary wound healing in terms of postoperative wound infections according to the Center of Disease Control and Prevention (CDC) definitions. The secondary outcomes are time to complete wound healing (days) and esthetical outcome (subjective preference of patients and Vancouver Scar Scale score). DISCUSSION: This study aims to answer how to deal with the pin site after removal of the external fixator. To date, no routine and generally accepted protocol exists for the management of pin sites after removal of the external fixator. This prospective, randomized controlled, blinded monocenter trial should determine whether primary wound closure or secondary wound healing should be advocated after removal of the external fixator.

trial registrationClinicalTrials.gov, ID: NCT03842956. Registered retrospectively on 13 February 2019.

Indexed as

Wound HealingAntibiotic ProphylaxisBone NailsEquivalence Trials as TopicExternal FixatorsHumansProspective StudiesRandomized Controlled Trials as TopicSurgical Wound InfectionTreatment OutcomeWounds and InjuriesExternal fixatorFixateur externeFixator externalFix-ExInfectionPin sitePin-tract infectionTraumaWound healing

Identifiers

PMID32075685
PMCPMC7031911
OpenAlexW3012759755

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.