Evidence map›Paper›PMID 26478104›Full record

Trial reportAmerican journal of obstetrics and gynecology2016

Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial.

Daniel G Kiefer, Jolene C Muscat, Jarrett Santorelli, Martin R Chavez, Cande V Ananth, John C Smulian, Anthony M Vintzileos

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of obstetrics and gynecology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 19% 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, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Dressings for the prevention of surgical site infection.The Cochrane database of systematic reviews · 2016
    Pooled it
  3. Review
  4. Review
  5. Review
  6. Postoperative Abdominal Adhesions: Clinical Significance and Advances in Prevention and Management.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2017
    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

7 authors at 4 institutions in 1 country.

Daniel G KieferDepartment of Obstetrics and Gynecology, Lehigh Valley Health Network, Allentown, PA; Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY; Department of Obstetrics, Gynecology, and Reproductive Medicine, Stony Brook University, Stony Brook, NY. Electronic address: Daniel_g.kiefer@lvhn.org.
Jolene C MuscatDepartment of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY.
Jarrett SantorelliDepartment of Obstetrics, Gynecology, and Reproductive Medicine, Stony Brook University, Stony Brook, NY; Department of Surgery, University of Buffalo, Buffalo, NY.
Martin R ChavezDepartment of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY.
Cande V AnanthDepartment of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY.
John C SmulianDepartment of Obstetrics and Gynecology, Lehigh Valley Health Network, Allentown, PA.
Anthony M VintzileosDepartment of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY.
Winthrop-University Hospital · USColumbia University · USLehigh Valley Hospital-Pocono · USStony Brook University · US

Funding

World Trade Center Worker and Volunteer Medical Screening ProgramM01RR010710 · NCRR · STATE UNIVERSITY NEW YORK STONY BROOK · PI GOLDSTEIN, RITA Z · 1998 to 2009
$17.6M
NCRR NIH HHS M01 RR010710NCRR NIH HHS MO1RR10710
6 · The paper itself

Abstract

backgroundThe rising cesarean birth rate has drawn attention to risks associated with repeat cesarean birth. Prevention of adhesions with adhesion barriers has been promoted as a way to decrease operative difficulty. However, robust data demonstrating effectiveness of such interventions are lacking.

objectiveWe report data from a multicenter trial designed to evaluate the short-term safety and effectiveness of a modified sodium hyaluronic acid (HA)-carboxymethylcellulose (CMC) absorbable adhesion barrier for reduction of adhesions following cesarean delivery. STUDY

designPatients who underwent primary or repeat cesarean delivery were included in this multicenter, single-blinded (patient), randomized controlled trial. Patients were randomized into either HA-CMC (N = 380) or no treatment (N = 373). No other modifications to their treatment were part of the protocol. Short-term safety data were collected following randomization. The location and density of adhesions (primary outcome) were assessed at their subsequent delivery using a validated tool, which can also be used to derive an adhesion score that ranges from 0-12.

resultsNo differences in baseline characteristics, postoperative course, or incidence of complications between the groups following randomization were noted. Eighty patients from the HA-CMC group and 92 controls returned for subsequent deliveries. Adhesions in any location were reported in 75.6% of the HA-CMC group and 75.9% of the controls (P = .99). There was no significant difference in the median adhesion score; 2 (range 0-10) for the HA-CMC group vs 2 (range 0-8) for the control group (P = .65). One third of the HA-CMC patients met the definition for severe adhesions (adhesion score >4) compared to 15.5% in the control group (P = .052). There were no significant differences in the time from incision to delivery (P = .56). Uterine dehiscence in the next pregnancy was reported in 2 patients in HA-CMC group vs 1 in the control group (P = .60).

conclusionAlthough we did not identify any short-term safety concerns, HA-CMC adhesion barrier applied at cesarean delivery did not reduce adhesion formation at the subsequent cesarean delivery.

Indexed as

AdultCarboxymethylcellulose SodiumCesarean SectionDrug CombinationsFemaleHumansHyaluronic AcidPregnancySingle-Blind MethodTime FactorsTissue AdhesionsCarboxymethylcellulose SodiumDrug CombinationsHyaluronic Acidadhesion barrieradhesion formationadhesionscesareanmodified sodium hyaluronic acid carboxymethylcelluloseSeprafilm

Identifiers

PMID26478104
PMCPMC4818004
OpenAlexW1783995020

What OpenQuestion holds

Textmetadata
LicenceTDM
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.