Evidence map›Paper›PMID 36527046›Full record

Trial reportJournal of cardiothoracic surgery2022

Single-blind, randomized study comparing clinical equivalence of trulene and prolene polypropylene sutures in elective primary coronary artery bypass graft surgery.

Ravi Shankar Shetty, Ajay Kaul, Aayush Goyal, Govardhan Reddy Konda, Sushant Srivastava, Ashok Kumar Moharana, T S Deepak

Open access · goldAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in Journal of cardiothoracic surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 42% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

7 authors at 3 institutions in 1 country.

Ravi Shankar ShettyDepartment of Cardio-Thoracic and Vascular Surgery, M S Ramaiah Medical College and Hospitals, Bangalore, Karnataka, 560054, India.
Ajay KaulDepartment of Cardio-Thoracic and Vascular Surgery, BLK-Max Super Speciality Hospital, New Delhi, 110005, India.
Aayush GoyalDepartment of Cardio-Thoracic and Vascular Surgery, BLK-Max Super Speciality Hospital, New Delhi, 110005, India. goyalaa1986@gmail.com.
Govardhan Reddy KondaDepartment of Cardio-Thoracic and Vascular Surgery, M S Ramaiah Medical College and Hospitals, Bangalore, Karnataka, 560054, India.
Sushant SrivastavaDepartment of Cardio-Thoracic and Vascular Surgery, BLK-Max Super Speciality Hospital, New Delhi, 110005, India.
Ashok Kumar MoharanaClinical Affairs, Healthium Medtech Limited, Bangalore, Karnataka, 560064, India.
T S DeepakClinical Affairs, Healthium Medtech Limited, Bangalore, Karnataka, 560064, India.
BLK Super Speciality Hospital · INM.S. Ramaiah Medical College · INMax Super Speciality Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCoronary artery bypass graft surgery (CABG) is one of the principle therapies for coronary artery disease, as it improves survival rate and quality of life (QoL). Polypropylene suture is commonly used in vascular and cardiac surgeries for anastomosis due to its long-term tensile strength and minimal tissue trauma. This study compared the clinical equivalence of Trulene® (Healthium Medtech Limited) and Prolene® (Ethicon-Johnson & Johnson) polypropylene sutures regarding incidence of myocardial infarction, stroke, renal failure and cardiac death (MACCE) occurring up to 26 weeks' period post-CABG surgery.

methodsThis multicenter, prospective, two-arm, parallel-group, randomized (1:1), single-blind study (n = 89) was conducted between August 2020 and September 2021. The primary endpoint, post-surgery cumulative incidence of MACCE was evaluated. In addition, anastomotic revision, surgical site infection (SSI), operative time, length of post-operative hospital stay, repeat revascularization, intraoperative suture handling characteristics, time taken to return to work and resume normal day to day activities, subject satisfaction score and QoL, and other adverse events were also recorded.

resultsA total of 80 (89.89%) males and 9 (10.11%) females participated in the study. No incidence of MACCE was recorded in any of the study participants. Non-significant difference was observed in anastomotic revision, SSI, operative time, post-operative hospital stay, revascularization, return to work and normal day-to-day activities, subject satisfaction score and QoL, and intraoperative handling parameters (except ease of passage) between the treatment groups, Trulene® and Prolene®. Compared to screening visit, proportion of subjects with 'no problems' for each QoL dimension and the mean visual analogue scale increased with each subsequent follow-up visit.

conclusionTrulene® polypropylene suture is clinically equivalent to Prolene® polypropylene suture and is safe and effective for anastomosis construction in CABG surgery during a routine clinical procedure. Trial registration CTRI Registration No.: CTRI/2020/05/025157 (Registered on: 13/05/2020).

Indexed as

Coronary Artery DiseasePercutaneous Coronary InterventionCoronary Artery BypassFemaleHumansMalePolypropylenesProspective StudiesQuality of LifeSingle-Blind MethodSurgical Wound InfectionSuturesTreatment OutcomePolypropylenesCoronary anastomosisCoronary artery bypass graft surgeryCoronary artery diseaseMajor adverse cardiac and cerebrovascular eventsPolypropylene suture

Identifiers

PMID36527046
PMCPMC9757631
OpenAlexW4312065958

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.