Evidence map›Paper›PMID 36121791›Full record

Trial reportPloS one2022

Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, non-inferiority study.

Jin Kyong Kim, Cho Rok Lee, Sang-Wook Kang, Jong Ju Jeong, Kee-Hyun Nam, Sung-Rae Cho, Seongmoon Jo, Eun Young Kim, Ji-Sup Yun, Hee Jin Park and 7 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 26% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Adhesion Reduction Agent Guardix-SGClinical Medicine Insights. Oncology · 2024
    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

17 authors at 3 institutions in 1 country.

Jin Kyong KimDepartment of Surgery, Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.ORCID 0000-0001-5121-8462
Cho Rok LeeDepartment of Surgery, Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Sang-Wook KangDepartment of Surgery, Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Jong Ju JeongDepartment of Surgery, Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.ORCID 0000-0002-4155-6035
Kee-Hyun NamDepartment of Surgery, Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Sung-Rae ChoDepartment and Research Institute of Rehabilitation Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Seongmoon JoDepartment and Research Institute of Rehabilitation Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Eun Young KimDepartment of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Ji-Sup YunDepartment of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Hee Jin ParkDepartment of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID 0000-0002-3135-0586
Mi Sung KimDepartment of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID 0000-0002-1523-1544
Kwangsoon KimDepartment of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Sohee LeeDepartment of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Ja Seong BaeDepartment of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
So Yeon JunDepartment of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Jihye ParkDepartment of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Jeong Soo KimDepartment of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0000-0002-9982-7838
Yonsei University · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRKangbuk Samsung Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMegaShield® is a newly developed temperature-sensitive anti-adhesive containing micronized acellular dermal matrix. The aim of this study was to investigate the efficacy and safety of MegaShield® compared with Guardix-SG® in the prevention of adhesions in patients undergoing bilateral total thyroidectomy.

methodWe conducted a multicenter trial between October 2018 and March 2020 in patients undergoing total thyroidectomy. The patients were randomly assigned to either the MegaShield® group or the Guardix-SG® group. The primary outcome was the esophageal movement using marshmallow six weeks after the surgery and the secondary outcome was the assessed adhesion score. The safety assessment was also evaluated.

resultsThe study included 70 patients each in the MegaShield® and control (Guardix-SG®) groups. Baseline clinical characteristics, the mean score of marshmallow esophagography, and the sum of adhesion scores were not statistically different between the two groups. Inferiority test demonstrated that the efficacy of MegaShield® is not inferior to that of Guardix-SG®. There were no device-related complications in both groups.

conclusionThe efficacy and safety of MegaShield® were not inferior than those of Guardix-SG®. MegaShield® demonstrated the potential of ADM as a potential future anti-adhesive agent.

trial registrationThe name of trial registry CRIS (Clinical Research Information Service) https://cris.nih.go.kr/cris/index.jsp. (The full trial protocol can be accessed) Registration number: KCT0003204.

Indexed as

Acellular DermisThyroidectomyDouble-Blind MethodHumansTemperatureTissue Adhesions

Identifiers

PMID36121791
PMCPMC9484646
OpenAlexW4296290419

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.