Evidence map›Paper›PMID 34865300›Full record

ArticleBJOG : an international journal of obstetrics and gynaecology2022

Evaluation of the short-term host response and biomechanics of an absorbable poly-4-hydroxybutyrate scaffold in a sheep model following vaginal implantation.

Chantal M Diedrich, Zeliha Guler, Lucie Hympanova, Eva Vodegel, Manuel Zündel, Edoardo Mazza, Jan Deprest, Jan Paul Roovers

Open access · hybridAbstract read
In one paragraph

Article in BJOG : an international journal of obstetrics and gynaecology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Chapter 4.5: New Proposed Treatments for Pelvic Organ Prolapse.International urogynecology journal · 2026
    Review
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  11. Review
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  13. Article
  14. Validation of an ovine vesicovaginal fistula model.International urogynecology journal · 2022
    Article
  15. Article
  16. Article
  17. Review
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 4 countries.

Chantal M DiedrichDepartment of Obstetrics and Gynaecology, Center for Reproductive Medicine (AMC), Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0002-0579-3535
Zeliha GulerDepartment of Obstetrics and Gynaecology, Center for Reproductive Medicine (AMC), Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0001-7293-8151
Lucie HympanovaCentre for Surgical Technologies, Biomedical Sciences Group, KU Leuven, Leuven, Belgium.
Eva VodegelDepartment of Obstetrics and Gynaecology, Center for Reproductive Medicine (AMC), Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0001-6897-9495
Manuel ZündelInstitute of Mechanical Systems, ETH Zurich, Zurich, Switzerland.
Edoardo MazzaInstitute of Mechanical Systems, ETH Zurich, Zurich, Switzerland.
Jan DeprestCentre for Surgical Technologies, Biomedical Sciences Group, KU Leuven, Leuven, Belgium.ORCID 0000-0002-4920-945X
Jan Paul RooversDepartment of Obstetrics and Gynaecology, Center for Reproductive Medicine (AMC), Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Amsterdam University Medical Centers · NLETH Zurich · CHCharles University · CZKU Leuven · BE

Funding

Tepha, Inc., Lexington, MA, USA
6 · The paper itself

Abstract

objectiveTo evaluate the host- and biomechanical response to a fully absorbable poly-4-hydroxybutyrate (P4HB) scaffold in comparison with the response to polypropylene (PP) mesh.

designIn vivo animal experiment.

settingKU Leuven Center for Surgical Technologies. POPULATION: Fourteen parous female Mule sheep.

methodsP4HB scaffolds were surgically implanted in the posterior vaginal wall of sheep. The comparative PP mesh data were obtained from an identical study protocol performed previously.

main outcome measuresGross necropsy, host response and biomechanical evaluation of explants, and the in vivo P4HB scaffold degradation were evaluated at 60- and 180-days post-implantation. Data are reported as mean ± standard deviation (SD) or standard error of the mean (SEM).

resultsGross necropsy revealed no implant-related adverse events using P4HB scaffolds. The tensile stiffness of the P4HB explants increased at 180-days (12.498 ± 2.66 N/mm SEM [p =0.019]) as compared to 60-days (4.585 ± 1.57 N/mm) post-implantation, while P4HB degraded gradually. P4HB scaffolds exhibited excellent tissue integration with dense connective tissue and a moderate initial host response. P4HB scaffolds induced a significantly higher M2/M1 ratio (1.70 ± 0.67 SD, score 0-4), as compared to PP mesh(0.99 ± 0.78 SD, score 0-4) at 180-days.

conclusionsP4HB scaffold facilitated a gradual load transfer to vaginal tissue over time. The fully absorbable P4HB scaffold, in comparison to PP mesh, has a favorable host response with comparable load-bearing capacity. If these results are also observed at longer follow-up in-vivo, a clinical study using P4HB for vaginal POP surgery may be warranted to demonstrate efficacy. TWEETABLE ABSTRACT: Degradable vaginal P4HB implant might be a solution for treatment of POP.

Indexed as

PolypropylenesSurgical MeshAnimalsBiomechanical PhenomenaFemaleHumansHydroxybutyratesSheepVaginaHydroxybutyratesPolypropylenesbiomechanicsdegradable scaffoldhost responsepelvic organ prolapsepoly-4-hydroxybutyratevaginal surgery

Identifiers

PMID34865300
PMCPMC9303173
OpenAlexW4200023453

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.