Evidence map›Paper›PMID 39521848›Full record

Trial reportScientific reports2024

Efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trial.

Peng Luo, Qi Lai, Li Xu, Zhenzhong Chen, Runsheng Guo, Banglin Xie, Ping Yi, Zhiying Yang, Bin Zhang

Abstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. 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

9 authors.

Peng Luo *Orthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, No. 17 Yong Wai Zheng Street, Nanchang, Jiangxi, 330006, China.
Qi Lai *Orthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, No. 17 Yong Wai Zheng Street, Nanchang, Jiangxi, 330006, China.
Li Xu *Department of Hepatic-Biliary-Pancreatic Surgery, China-Japan Friendship Hospital, No. 2 Ying Hua East Street, Chao Yang District, Beijing, 100029, China.
Zhenzhong ChenDepartment of Orthopedics, Lishui Municipal Central Hospital, 289 Kuocang Road, Lishui, Zhejiang, 323000, China.
Runsheng GuoOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, No. 17 Yong Wai Zheng Street, Nanchang, Jiangxi, 330006, China.
Banglin XieOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, No. 17 Yong Wai Zheng Street, Nanchang, Jiangxi, 330006, China.
Ping YiDepartment of Spine Surgery, China-Japan Friendship Hospital, No. 2 Yinghua East Street, Chao Yang District, Beijing, 100029, China. pennylfj@163.com.
Zhiying YangDepartment of Hepatic-Biliary-Pancreatic Surgery, China-Japan Friendship Hospital, No. 2 Ying Hua East Street, Chao Yang District, Beijing, 100029, China. yangzhy@aliyun.com.
Bin ZhangOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, No. 17 Yong Wai Zheng Street, Nanchang, Jiangxi, 330006, China. ndyfy01354@ncu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Borayflo Haemostatic matrix is a new absorbable hemostatic gelatin matrix which can be used for intraoperative assisted hemostasis. In a prospective, multicenter, non-inferiority, randomized controlled trial, a total of 354 subjects were recruited from the departments of hepatobiliary surgery, obstetrics and gynaecology and orthopaedics of 4 hospitals and randomly allocated to test group (Borayflo Haemostatic matrix) or control group (Surgiflo Haemostatic matrix) in a 1:1 ratio. In the modified intention-to-treat population, 163 (93.14%) of 175 subjects in the test group versus 167 (94.89%) of 176 subjects in the control group successfully achieved hemostasis within 5 min (P > 0.05). Non-inferiority for effective rates of hemostasis at 5 min to Surgiflo Haemostatic matrix was shown in the study (treatment difference: -1.74% [95%CI, -6.70-3.22%] for modified intention-to-treat population). In terms of efficacy and safety, the new hemostatic gelatin matrix (Borayflo Haemostatic matrix) is equivalent to Surgiflo Haemostatic matrix. There was no significant difference in the incidence of AEs or SAEs between the test and control groups(P > 0.05). In addition, Borayflo Haemostatic matrix is a domestically produced haemostatic gelatin product, an advantage that will reduce the cost of surgical haemostasis for Chinese patients.

Indexed as

GelatinHemostaticsAdultAgedBlood Loss, SurgicalFemaleGelatin Sponge, AbsorbableHemostasisHemostasis, SurgicalHumansMaleMiddle AgedProspective StudiesTreatment OutcomeGelatinHemostatics

Identifiers

PMID39521848
PMCPMC11550802

What OpenQuestion holds

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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.