Evidence map›Paper›PMID 31592026›Full record

ArticlePlastic and reconstructive surgery. Global open2019

Acellular Dermal Matrix Sterility: Does It Affect Microbial and Clinical Outcomes Following Implantation?

Gabriel M Klein, Gurtej Singh, Jocellie Marquez, Matthew Gebre, Robert Barry, Tara L Huston, Jason C Ganz, Sami U Khan, Alexander B Dagum, Duc T Bui

Open access · goldAbstract read
In one paragraph

Article in Plastic and reconstructive surgery. Global open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  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

10 authors at 2 institutions in 1 country.

Gabriel M KleinDivision of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, N.Y.
Gurtej SinghDivision of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, N.Y.
Jocellie MarquezDivision of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, N.Y.
Matthew GebreStony Brook University School of Medicine, Stony Brook, N.Y.
Robert BarryStony Brook University School of Medicine, Stony Brook, N.Y.
Tara L HustonDivision of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, N.Y.
Jason C GanzDivision of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, N.Y.
Sami U KhanDivision of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, N.Y.
Alexander B DagumDivision of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, N.Y.
Duc T BuiDivision of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, N.Y.
Stony Brook University Hospital · USStony Brook University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The use of acellular dermal matrices (ADMs) in breast reconstruction is a controversial topic. Recent literature has investigated the effects of ADM sterilization on infectious complications, although with varying conclusions. Previous work by our group showed no difference between aseptic and sterilized products immediately out of the package. In this study, we investigate the microbiologic profiles of these agents after implantation.

methodsIn this prospective study, we cultured samples of ADM previously implanted during the first stage of tissue expander-based immediate breast reconstruction. A 1 cm2 sample was excised during the stage II expander-implant exchange procedure, and samples were incubated for 48 hours in tryptic soy broth. Samples with growth were further cultured on tryptic soy broth and blood agar plates. Patient records were also analyzed, to determine if ADM sterilization and microbial growth were correlated with infectious complications.

resultsIn total, 51 samples of ADM were collected from 32 patients. Six samples were from aseptic ADM (AlloDerm), 27 samples were from ADM sterilized to 10-3 (AlloDerm Ready-to-Use), and 18 samples were from products sterilized to 10-6 (AlloMax). No samples demonstrated bacterial growth. Only 5 patients experienced postoperative complications, of whom only 1 patient was infectious in nature. We failed to demonstrate a statistically significant correlation between sterility and postoperative complications.

conclusionsOur findings showed no difference in microbial presence and clinical outcomes when comparing ADM sterility. Furthermore, no samples demonstrated growth in culture. Our study brings into question the necessity for terminal sterilization in these products.

Identifiers

PMID31592026
PMCPMC6756679
OpenAlexW2968679703

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.