Evidence map›Paper›PMID 26844840›Full record

Trial reportThe New England journal of medicine2016

A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery.

Methodius G Tuuli, Jingxia Liu, Molly J Stout, Shannon Martin, Alison G Cahill, Anthony O Odibo, Graham A Colditz, George A Macones

4 registry-linked trialsOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 58 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 6 pooled it
34.8field-weighted citation impact, top 1% 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.

NCT01472549 nacompletednot on this map

Antiseptic Skin Preparation for Preventing Surgical Site Infection at Cesarean Delivery: a Randomized Comparative Effectiveness Trial

TypeinterventionalSponsorWashington University School of MedicineRan2011 to 2015Enrolled1,147ConditionsSurgical Site InfectionsArmsIodine-alcohol, Chlorhexidine-alcohol
NCT03133312 phase4completednot on this mapstarted 2017, after this paper: background citation

A Single Site Prospective Randomized Controlled Trial Comparing Chlorhexidine Gluconate and Povidone-Iodine as Vaginal Preparation Antiseptics for Cesarean Section to Determine Effect on Bacterial Load

TypeinterventionalSponsorMetro Health, MichiganRan2017 to 2017Enrolled100ConditionsInfection, BacterialArmsChlorhexidine Gluconate, Povidone-Iodine Scrub and Paint
NCT04202471 nawithdrawnnot on this mapstarted 2020, after this paper: background citation

Preoperative Chlorhexidine Cloths to Reduce Surgical Site Infection in Non-Scheduled Cesarean Deliveries

TypeinterventionalSponsorNorthwell HealthRan2020 to 2021Enrolled0ConditionsSurgical Site InfectionArmsChlorhexidine Cloth
NCT05953714 nacompletednot on this mapstarted 2020, after this paper: background citation

The effect of using chlorhexidine gluconate and povidone iodine solution on the healing process before a cesarean section

TypeinterventionalSponsorSakarya UniversityRan2020 to 2021Enrolled102ConditionsEvaluate to Effects of Two Antiseptic Products and ShoweringArmsincision side cleaning with antiseptic products
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 6 syntheses or guidelines pooled it, 246 citations in OpenAlex.

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  3. Skin preparation for preventing infection following caesarean section.The Cochrane database of systematic reviews · 2020
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  5. Skin preparation for preventing infection following caesarean section.The Cochrane database of systematic reviews · 2018
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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 2 institutions in 1 country.

Methodius G TuuliFrom the Department of Obstetrics and Gynecology (M.G.T., M.J.S., S.M., A.G.C., G.A.M.) and the Division of Public Health Sciences (J.L., G.A.C.), Washington University School of Medicine in St. Louis, St. Louis; and the Department of Obstetrics and Gynecology, University of South Florida, Tampa (A.O.O.).
Jingxia Liu
Molly J Stout
Shannon Martin
Alison G Cahill
Anthony O Odibo
Graham A Colditz
George A Macones
Washington University in St. Louis · USUniversity of South Florida · US

Funding

Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
Women's Reproductive Health Research Career Development Program at W.U., St LouisK12HD063086 · NICHD · WASHINGTON UNIVERSITY · PI MACONES, GEORGE A · 2009 to 2013
$2.6M
NCATS NIH HHS UL1 TR000448NICHD NIH HHS 1K12HD063086-01NICHD NIH HHS K12 HD063086
6 · The paper itself

Abstract

backgroundPreoperative skin antisepsis has the potential to decrease the risk of surgical-site infection. However, evidence is limited to guide the choice of antiseptic agent at cesarean delivery, which is the most common major surgical procedure among women in the United States.

methodsIn this single-center, randomized, controlled trial, we evaluated whether the use of chlorhexidine-alcohol for preoperative skin antisepsis was superior to the use of iodine-alcohol for the prevention of surgical-site infection after cesarean delivery. We randomly assigned patients undergoing cesarean delivery to skin preparation with either chlorhexidine-alcohol or iodine-alcohol. The primary outcome was superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of definitions from the Centers for Disease Control and Prevention.

resultsFrom September 2011 through June 2015, a total of 1147 patients were enrolled; 572 patients were assigned to chlorhexidine-alcohol and 575 to iodine-alcohol. In an intention-to-treat analysis, surgical-site infection was diagnosed in 23 patients (4.0%) in the chlorhexidine-alcohol group and in 42 (7.3%) in the iodine-alcohol group (relative risk, 0.55; 95% confidence interval, 0.34 to 0.90; P=0.02). The rate of superficial surgical-site infection was 3.0% in the chlorhexidine-alcohol group and 4.9% in the iodine-alcohol group (P=0.10); the rate of deep infection was 1.0% and 2.4%, respectively (P=0.07). The frequency of adverse skin reactions was similar in the two groups.

conclusionsThe use of chlorhexidine-alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than did the use of iodine-alcohol. (Funded by the National Institutes of Health and Washington University School of Medicine in St. Louis; ClinicalTrials.gov number, NCT01472549.).

Indexed as

Cesarean SectionAdultAnti-Infective Agents, LocalAntisepsisChlorhexidineFemaleHumansIodinePregnancySkinSurgical Wound InfectionAnti-Infective Agents, LocalChlorhexidineIodine

Identifiers

PMID26844840
PMCPMC4777327
OpenAlexW2315032641

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.