Evidence map›Paper›PMID 31335776›Full record

Trial reportTransplantation2020

A 3-month, Multicenter, Randomized, Open-label Study to Evaluate the Impact on Wound Healing of the Early (vs Delayed) Introduction of Everolimus in De Novo Kidney Transplant Recipients, With a Follow-up Evaluation at 12 Months After Transplant (NEVERWOUND Study).

Tommaso Maria Manzia, Mario Carmellini, Paola Todeschini, Antonio Secchi, Silvio Sandrini, Enrico Minetti, Lucrezia Furian, Gionata Spagnoletti, Francesco Pisani, Gian Benedetto Piredda and 2 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Transplantation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 31% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Immunomodulators for Non-Melanoma Skin Cancers: Updated Perspectives.Clinical, cosmetic and investigational dermatology · 2023
    Review
  5. Review
  6. 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

12 authors at 4 institutions in 1 country.

Tommaso Maria ManziaFondazione Policlinico Tor Vergata, Dipartimento Scienze Chirurgiche, Università degli Studi di Roma Tor Vergata, Roma, Italy.
Mario CarmelliniAOU Senese, Siena, Italy.
Paola TodeschiniDipartimento di Medicina Specialistica diagnostica e sperimentale, Università di Bologna, Bologna, Italy.
Antonio SecchiVita Salute San Raffaele University, Milano, Italy.
Silvio SandriniAO Spedali Civili, Brescia, Italy.
Enrico MinettiAOU Careggi, Firenze, Italy.
Lucrezia FurianAOU di Padova, Padova, Italy.
Gionata SpagnolettiPU A.Gemelli, Roma, Italy.
Francesco PisaniPOU S.Salvatore, L'Aquila, Italy.
Gian Benedetto PireddaAO G.Brotzu, Cagliari, Italy.
Gianni CappelliAOUP di Modena, Modena, Italy.
GIuseppe TisoneFondazione Policlinico Tor Vergata, Dipartimento Scienze Chirurgiche, Università degli Studi di Roma Tor Vergata, Roma, Italy.
Azienda Ospedaliera Universitaria Senese · ITAzienda Ospedaliero-Universitaria Careggi · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe risk of wound healing complications (WHCs) and the early use of mammalian target of rapamycin inhibitors after kidney transplantation (KT) have not been fully addressed.

methodsThe NEVERWOUND study is a 3-month, multicenter, randomized, open-label study designed to evaluate whether a delayed (ie, 28 ± 4 d posttransplant) immunosuppression regimen based on everolimus (EVR) reduces the risk of WHC versus EVR started immediately after KT. Secondary endpoints were treatment failure (biopsy-proven acute rejection, graft loss, or death), delayed graft function, patient and graft survival rates, and renal function.

resultsOverall, 394 KT recipients were randomized to receive immediate (N = 197) or delayed (N = 197) EVR after KT. At 3 months, WHC-free rates in the immediate EVR versus delayed EVR arm, considering the worst- and best-case scenario approach, were 0.68 (95% confidence interval [CI], 0.62-0.75) versus 0.62 (95% CI, 0.55-0.68) (log-rank P = 0.56) and 0.70 (95% CI, 0.64-0.77) versus 0.72 (95% CI, 0.65-0.78) (log-rank P = 0.77), respectively. The 3- and 12-month treatment failure rates, delayed graft function and renal function, and patient and graft survival were not different between the arms.

conclusionsThe early introduction of EVR after KT did not increase the risk of WHC, showing good efficacy and safety profile.

Indexed as

Transplant RecipientsBiopsyEverolimusFemaleFollow-Up StudiesGraft RejectionHumansImmunosuppressive AgentsIncidenceItalyKidney TransplantationMaleMiddle AgedPostoperative PeriodProspective StudiesSurvival RateEverolimusImmunosuppressive Agents

Identifiers

PMID31335776
PMCPMC7004468
OpenAlexW2963028553

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.