Evidence map›Paper›PMID 25096386›Full record

Trial reportAnnals of surgical oncology2014

Randomized trial of drain antisepsis after mastectomy and immediate prosthetic breast reconstruction.

Amy C Degnim, Tanya L Hoskin, Rushin D Brahmbhatt, Anne Warren-Peled, Margie Loprinzi, Emily S Pavey, Judy C Boughey, Tina J Hieken, Steven Jacobson, Valerie Lemaine and 15 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of surgical oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03229824 (Randomized Controlled Trial to Reduce Surgical Site Infections in Breast Cancer Surgery With Clorhexidine Gluconate Securement Dressing), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT03229824 nacompletednot on this mapstarted 2016, after this paper: background citation

Randomized Controlled Trial to Reduce Surgical Site Infections in Breast Cancer Surgery With Clorhexidine Gluconate Securement Dressing (Tegaderm CHG)

TypeinterventionalSponsorNational Institute of CancerologíaRan2016 to 2018Enrolled116ConditionsBreast CancerArmsAntiseptic occlusive dressing group
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Observational
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

25 authors at 3 institutions in 1 country.

Amy C DegnimDepartment of Surgery, Mayo Clinic, Rochester, MN, USA, degnim.amy@mayo.edu.
Tanya L Hoskin
Rushin D Brahmbhatt
Anne Warren-Peled
Margie Loprinzi
Emily S Pavey
Judy C Boughey
Tina J Hieken
Steven Jacobson
Valerie Lemaine
James W Jakub
Chetan Irwin
Robert D Foster
Hani Sbitany
Michel Saint-Cyr
Erin Duralde
Sheri Ramaker
Robin Chin
Monica Sieg
Melissa Wildeman
Jeffrey S Scow
Robin Patel
Karla Ballman
Larry M Baddour
Laura J Esserman
Mayo Clinic in Arizona · USUniversity of California, San Francisco · USMayo Clinic in Florida · US

Funding

Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
NCATS NIH HHS UL1 TR000135
6 · The paper itself

Abstract

backgroundIn this 2-site randomized trial, we investigated the effect of antiseptic drain care on bacterial colonization of surgical drains and infection after immediate prosthetic breast reconstruction.

methodsWith IRB approval, we randomized patients undergoing bilateral mastectomy and reconstruction to drain antisepsis (treatment) for one side, with standard drain care (control) for the other. Antisepsis care included both: chlorhexidine disc dressing at drain exit site(s) and irrigation of drain bulbs twice daily with dilute sodium hypochlorite solution. Cultures were obtained from bulb fluid at 1 week and at drain removal, and from the subcutaneous drain tubing at removal. Positive cultures were defined as ≥1+ growth for fluid and >50 CFU for tubing.

resultsCultures of drain bulb fluid at 1 week (the primary endpoint) were positive in 9.9 % of treatment sides (10 of 101) versus 20.8 % (21 of 101) of control sides (p = 0.02). Drain tubing cultures were positive in 0 treated drains versus 6.2 % (6 of 97) of control drains (p = 0.03). Surgical site infection occurred within 30 days in 0 antisepsis sides versus 3.8 % (4 of 104) of control sides (p = 0.13), and within 1 year in three of 104 (2.9 %) of antisepsis sides versus 6 of 104 (5.8 %) of control sides (p = 0.45). Clinical infection occurred within 1 year in 9.7 % (6 of 62) of colonized sides (tubing or fluid) versus 1.5 % (2 of 136) of noncolonized sides (p = 0.03).

conclusionsSimple and inexpensive local antiseptic interventions with a chlorhexidine disc and hypochlorite solution reduce bacterial colonization of drains, and reduced drain colonization was associated with fewer infections.

Indexed as

AntisepsisMammaplastyMastectomyAdultAgedBreast NeoplasmsCathetersDrainageFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm StagingPostoperative CarePrognosisProspective Studies

Identifiers

PMID25096386
PMCPMC4373621
OpenAlexW2030242391

What OpenQuestion holds

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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.