Evidence map›Paper›PMID 32207575›Full record

Trial reportBJS open2020

Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial.

K Ausen, A I Hagen, H S Østbyhaug, S Olafsson, B J Kvalsund, O Spigset, H Pleym

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BJS open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 6% 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.

NCT02627560 phase4completednot on this map

The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled Double Blinded Randomized Study

TypeinterventionalSponsorSt. Olavs HospitalRan2016 to 2018Enrolled202ConditionsPostoperative Hemorrhage, Breast Neoplasms, SeromaArmsTranexamic Acid, saline
NCT04541303 early_phase1completednot on this map

Randomized Study on the Topical Application of Tranexamic Acid to Wound Bed for Hemostasis in the Setting Granulating Wounds Following Mohs Micrographic Surgery

TypeinterventionalSponsorUniversity of Missouri-ColumbiaRan2020 to 2021Enrolled124ConditionsPostoperative Wound HaemorrhageArmsTranexamic acid, normal saline
NCT05554211 phase2withdrawnnot on this mapstarted 2022, after this paper: background citation

Tranexamic Acid Usage in Bilateral Mastectomy to Reduce Post-surgical Drainage

TypeinterventionalSponsorNorthwestern UniversityRan2022 to 2024Enrolled0ConditionsBreast Cancer, BRCA MutationArmsTranexamic acid, Normal saline
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

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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

7 authors at 3 institutions in 1 country.

K AusenSection for Plastic and Reconstructive Surgery, Clinic of Surgery, St Olav's University Hospital, Trondheim, Norway.ORCID 0000-0001-6247-5608
A I HagenSection for Breast and Endocrine Surgery, Clinic of Surgery, St Olav's University Hospital, Trondheim, Norway.
H S ØstbyhaugSection for Breast and Endocrine Surgery, Clinic of Surgery, St Olav's University Hospital, Trondheim, Norway.
S OlafssonSection for Breast and Endocrine Surgery, Department of Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.
B J KvalsundSection for Breast and Endocrine Surgery, Department of Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.
O SpigsetDepartment of Clinical Pharmacology, St Olav's University Hospital, Trondheim, Norway.
H PleymClinic of Anaesthesia and Intensive Care, St Olav's University Hospital, Trondheim, Norway.
Norwegian University of Science and Technology · NOÅlesund Hospital · NOSt Olav's University Hospital · NO

Funding

The Liaison Committee between the Central Norway Regional Health Authority (RHA)the Norwegian University of Science and Technology-NTNU, Trondheim, Norway 2016/29014
6 · The paper itself

Abstract

backgroundTopical administration of tranexamic acid (TXA) may be an alternative to intravenous administration to reduce bleeding with a lower risk of systemic adverse events. The aim of this study was to investigate whether moistening a surgical wound with TXA before closure, leaving a thin film of drug only, would reduce postoperative bleeding.

methodsThis was a two-centre, stratified, parallel-group, placebo-controlled, double-blind RCT. Patients undergoing mastectomy with or without axillary lymph node clearance were randomized 1 : 1 to moistening of wound surface before closure with either 25 mg/ml TXA or 0·9 per cent sodium chloride (placebo). The primary endpoint was postoperative bleeding as measured by drain production in the first 24 h. Secondary endpoints were early haematoma, total drain production, postoperative complications and late aspirations of seroma within 3 months.

resultsBetween 1 January 2016 and 31 August 2018, 208 patients were randomized. Two patients were converted to a different surgical procedure at surgery, and four did not receive the intervention owing to technical error. Thus, 202 patients were included in the study (101 in the TXA and 101 in the placebo group). TXA reduced mean drain production at 24 h (110 versus 144 ml; mean difference 34 (95 per cent c.i. 8 to 60) ml, P = 0·011). One patient in the TXA group had early haematoma compared with seven in the placebo group (odds ratio (OR) 0·13 (95 per cent c.i. 0·02 to 1·07); P = 0·057). There was no significant difference in postoperative complications between TXA and placebo (13 versus 10; OR 1·11 (0·45 to 2·73), P = 0·824) or need for late seroma aspirations (79 versus 67 per cent; OR 1·83 (0·91 to 3·68), P = 0·089).

conclusionMoistening the wound with TXA 25 mg/ml before closure reduces postoperative bleeding within the first 24 h in patients undergoing mastectomy. Registration number: NCT02627560 (https://clinicaltrials.gov).

Indexed as

MastectomyAdministration, TopicalAgedAntifibrinolytic AgentsBreast NeoplasmsDouble-Blind MethodFemaleHumansLogistic ModelsMiddle AgedNorwayPostoperative HemorrhageTranexamic AcidTreatment OutcomeAntifibrinolytic AgentsTranexamic Acid

Identifiers

PMID32207575
PMCPMC7093788
OpenAlexW2998346198

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.