Evidence map›Paper›PMID 33955178›Full record

ArticleInternational wound journal2022

A prospective clinical trial evaluating changes in the wound microenvironment in patients with chronic venous leg ulcers treated with a hypothermically stored amniotic membrane.

John P McQuilling, Marissa J Carter, Judith A Fulton, Keyur Patel, Bryan Doner, Thomas E Serena, Katie C Mowry

Open access · goldAbstract read
In one paragraph

Article in International wound journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 22% 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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Cytokines and Venous Leg Ulcer Healing-A Systematic Review.International journal of molecular sciences · 2022
    Pooled it
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. A simplified method for monitoring cytokines in wound fluid.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society · 2023
    Article
  11. Article
  12. 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 4 institutions in 1 country.

John P McQuillingOrganogenesis, Birmingham, Alabama, USA.
Marissa J CarterStategic Solutions Inc., Bozeman, Montana, USA.
Judith A FultonSerenaGroup Inc., Cambridge, Massachusetts, USA.
Keyur PatelArmstrong CM Hospital, The Snyder Institute, Kittaning, Pennsylvania, USA.
Bryan DonerSerenaGroup Inc., Cambridge, Massachusetts, USA.
Thomas E SerenaStategic Solutions Inc., Bozeman, Montana, USA.
Katie C MowryOrganogenesis, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0002-0047-544X
Montana State University · USOrganogenesis (United States) · USSerenaGroup Research Institute · USArmstrong Center for Medicine & Health · US

Funding

Organogenesis
6 · The paper itself

Abstract

Amniotic tissues have been long utilised to treat chronic wounds; however, there are few studies evaluating how the wound microenvironment responds to these therapies. The goal of this study was to evaluate the changes in wounds treated with a hypothermically stored amniotic membrane (HSAM). In this prospective single-arm study, 15 female patients with venous leg ulcers were treated with HSAM from male donors and standard of care for 12 weeks. Over the course of the study, wound exudate was collected and evaluated using proteomic microarrays. Biopsies were collected during the course of treatment to detect the presence of HSAM tissue. By 4 weeks, 60% of subjects achieved 50% or greater reduction in wound size, and by 12 weeks, 53% of subjects achieved 100% re-epithelialization. HSAM DNA was detected in 20% of biopsies as determined by the detection TSPY4, indicating HSAM was no longer present within the wound bed approximately 7 days from the last treatment for the majority of wounds. Proteomic analysis of wound exudate found that wounds on a healing trajectory had significantly higher levels of MMP-10, MMP-7, and TIMP-4 and significantly lower levels of CX3CL1, FLT-3 L, IL-1ra, IL-1a, IL-9, IL-2, IL-3, MCP-1, and TNF-b compared with other wounds.

Indexed as

AmnionVaricose UlcerFemaleHumansMaleProspective StudiesProteomicsWound Healingamnion allografthypothermically stored amniotic membrane (HSAM)placental membranevenous leg ulcerwound fluid

Identifiers

PMID33955178
PMCPMC8684864
OpenAlexW3157287236

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.