Evidence map›Paper›PMID 25968005›Full record

Trial reportBMJ open2015

Exploratory clinical trial of combination wound therapy with a gelatin sheet and platelet-rich plasma in patients with chronic skin ulcers: study protocol.

Naoki Morimoto, Natsuko Kakudo, Makoto Matsui, Tsunetaka Ogura, Tomoya Hara, Kenji Suzuki, Masaya Yamamoto, Yasuhiko Tabata, Kenji Kusumoto

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
3.9field-weighted citation impact, top 7% 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

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Dressings and topical agents for treating venous leg ulcers.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Adjuvant Biological Therapies in Chronic Leg Ulcers.International journal of molecular sciences · 2017
    Pooled it
  3. Dressings and topical agents for treating pressure ulcers.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Autologous platelet-rich plasma for treating chronic wounds.The Cochrane database of systematic reviews · 2016
    Pooled it
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Effect of composite biodegradable biomaterials on wound healing in diabetes.Frontiers in bioengineering and biotechnology · 2022
    Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. 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 at 2 institutions in 1 country.

Naoki MorimotoDepartment of Plastic and Reconstructive Surgery, Kansai Medical University, Osaka, Japan.
Natsuko KakudoDepartment of Plastic and Reconstructive Surgery, Kansai Medical University, Osaka, Japan.
Makoto MatsuiDepartment of Biomaterials, Field of Tissue Engineering, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan.
Tsunetaka OguraDepartment of Plastic and Reconstructive Surgery, Kansai Medical University, Osaka, Japan.
Tomoya HaraDepartment of Plastic and Reconstructive Surgery, Kansai Medical University, Osaka, Japan.
Kenji SuzukiDepartment of Plastic and Reconstructive Surgery, Kansai Medical University, Osaka, Japan.
Masaya YamamotoDepartment of Biomaterials, Field of Tissue Engineering, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan.
Yasuhiko TabataDepartment of Biomaterials, Field of Tissue Engineering, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan.
Kenji KusumotoDepartment of Plastic and Reconstructive Surgery, Kansai Medical University, Osaka, Japan.
Kansai Medical University · JPKyoto University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic skin ulcers, such as diabetic ulcers, venous leg ulcers and pressure ulcers, are intractable and increasing in prevalence, representing a costly problem in healthcare. We developed a combination therapy with a gelatin sheet, capable of providing sustained release of platelet-rich plasma (PRP). The objective of this study is to investigate the safety and efficacy of autologous PRP covered with a hydrocolloid dressing and PRP covered with a gelatin sheet in the treatment of chronic skin ulcers. METHODS AND ANALYSIS: Thirty patients with chronic skin ulcers who have not healed with conventional therapy for at least 1 month are being recruited. The patients will receive PRP after debridement, and the wounds will be covered with a hydrocolloid dressing or gelatin sheet. The efficacy will be evaluated according to the time from the beginning of PRP application to secondary healing or the day on which wound closure is achieved with a relatively simple surgical procedure, such as skin grafting or suturing. All patients will be followed up until 6 weeks after application to observe adverse events related to the application of PRP and the dressings. This study was designed to address and compare the safety and efficacy of PRP covered with a hydrocolloid dressing versus a gelatin sheet. If successful, this combination therapy may be an alternative to bioengineered skin substitutes containing living cells and lead to substantial progress in the management of chronic skin ulcers. ETHICS AND DISSEMINATION: The study protocol was approved by the Institutional Review Board of Kansai Medical University (KMU Number 0649-1, 4 August 2014: V.1.0). The findings of this trial will be disseminated through peer-reviewed journals, and national and international scientific meetings as well as to the patients. TRIAL REGISTRATION NUMBER: UMIN000015689.

Indexed as

Platelet-Rich PlasmaAdultBandagesChronic DiseaseFemaleGelatinHumansHydrogelsMaleProspective StudiesSkin UlcerWound HealingGelatinHydrogelsPLASTIC & RECONSTRUCTIVE SURGERYWOUND MANAGEMENT

Identifiers

PMID25968005
PMCPMC4431137
OpenAlexW2131796219

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.