Evidence map›Paper›PMID 27826487›Full record

ArticlePlastic and reconstructive surgery. Global open2016

Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial.

Lawrence A DiDomenico, Dennis P Orgill, Robert D Galiano, Thomas E Serena, Marissa J Carter, Jarrod P Kaufman, Nathan J Young, Charles M Zelen

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Plastic and reconstructive surgery. Global open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
5.4field-weighted citation impact, top 4% 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.

NCT03294720 phase1completednot on this mapstarted 2018, after this paper: background citation

Augmentation of ACL Reconstruction With Bone Marrow Stem Cells and Amnion Collagen Matrix Wrap: a Case Series

TypeinterventionalSponsorAndrews Research & Education FoundationRan2018 to 2022Enrolled10ConditionsACL - Anterior Cruciate Ligament RuptureArmsBio-ACL, amnion wrap and BMAC
NCT03294759 naunknown statusnot on this mapstarted 2017, after this paper: background citation

Pilot Study: Augmentation of ACL Reconstruction With Bone Marrow Stem Cells and Amnion Collagen Matrix Wrap

TypeinterventionalSponsorAndrews Research & Education FoundationRan2017 to 2024Enrolled40ConditionsACL - Anterior Cruciate Ligament RuptureArmsBio ACL, Control
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 83 citations in OpenAlex.

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  13. Clinical Evaluation of AMNIODERM+Biotech (Basel (Switzerland)) · 2024
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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

8 authors at 1 institution in 1 country.

Lawrence A DiDomenicoLower Extremity Institute for Research and Therapy, Youngstown, Ohio; Department of Plastic Surgery, Brigham and Women's Hospital, Boston, Mass.; Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Ill.; Serena Group, Cambridge, Mass.; Strategic Solutions, Inc., Cody, Wyo.; General Surgery, Premier Surgical, Brick, N.J.; †Martinsville Research Institute, Martinsville, Va.; and ‡Professional Education and Research Institute, Roanoke, Va.
Dennis P OrgillLower Extremity Institute for Research and Therapy, Youngstown, Ohio; Department of Plastic Surgery, Brigham and Women's Hospital, Boston, Mass.; Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Ill.; Serena Group, Cambridge, Mass.; Strategic Solutions, Inc., Cody, Wyo.; General Surgery, Premier Surgical, Brick, N.J.; †Martinsville Research Institute, Martinsville, Va.; and ‡Professional Education and Research Institute, Roanoke, Va.
Robert D GalianoLower Extremity Institute for Research and Therapy, Youngstown, Ohio; Department of Plastic Surgery, Brigham and Women's Hospital, Boston, Mass.; Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Ill.; Serena Group, Cambridge, Mass.; Strategic Solutions, Inc., Cody, Wyo.; General Surgery, Premier Surgical, Brick, N.J.; †Martinsville Research Institute, Martinsville, Va.; and ‡Professional Education and Research Institute, Roanoke, Va.
Thomas E SerenaLower Extremity Institute for Research and Therapy, Youngstown, Ohio; Department of Plastic Surgery, Brigham and Women's Hospital, Boston, Mass.; Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Ill.; Serena Group, Cambridge, Mass.; Strategic Solutions, Inc., Cody, Wyo.; General Surgery, Premier Surgical, Brick, N.J.; †Martinsville Research Institute, Martinsville, Va.; and ‡Professional Education and Research Institute, Roanoke, Va.
Marissa J CarterLower Extremity Institute for Research and Therapy, Youngstown, Ohio; Department of Plastic Surgery, Brigham and Women's Hospital, Boston, Mass.; Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Ill.; Serena Group, Cambridge, Mass.; Strategic Solutions, Inc., Cody, Wyo.; General Surgery, Premier Surgical, Brick, N.J.; †Martinsville Research Institute, Martinsville, Va.; and ‡Professional Education and Research Institute, Roanoke, Va.
Jarrod P KaufmanLower Extremity Institute for Research and Therapy, Youngstown, Ohio; Department of Plastic Surgery, Brigham and Women's Hospital, Boston, Mass.; Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Ill.; Serena Group, Cambridge, Mass.; Strategic Solutions, Inc., Cody, Wyo.; General Surgery, Premier Surgical, Brick, N.J.; †Martinsville Research Institute, Martinsville, Va.; and ‡Professional Education and Research Institute, Roanoke, Va.
Nathan J YoungLower Extremity Institute for Research and Therapy, Youngstown, Ohio; Department of Plastic Surgery, Brigham and Women's Hospital, Boston, Mass.; Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Ill.; Serena Group, Cambridge, Mass.; Strategic Solutions, Inc., Cody, Wyo.; General Surgery, Premier Surgical, Brick, N.J.; †Martinsville Research Institute, Martinsville, Va.; and ‡Professional Education and Research Institute, Roanoke, Va.
Charles M ZelenLower Extremity Institute for Research and Therapy, Youngstown, Ohio; Department of Plastic Surgery, Brigham and Women's Hospital, Boston, Mass.; Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Ill.; Serena Group, Cambridge, Mass.; Strategic Solutions, Inc., Cody, Wyo.; General Surgery, Premier Surgical, Brick, N.J.; †Martinsville Research Institute, Martinsville, Va.; and ‡Professional Education and Research Institute, Roanoke, Va.
Brigham and Women's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAllogeneic grafts derived from amnion/chorion are known to be efficacious in healing chronic diabetic foot ulcerations (DFUs). The goal of this study was to compare aseptically processed dehydrated human amnion and chorion allograft (dHACA) versus standard of care (SOC) in facilitating wound closure in nonhealing DFUs.

methodsPatients with DFUs treated with SOC (off-loading, appropriate debridement, and moist wound care) after a 2-week screening period were randomized to either SOC or wound-size-specific dHACA (AmnioBand, Musculoskeletal Transplant Foundation, Edison, N.J.) applied weekly for up to 12 weeks plus SOC. Primary endpoint was the percentage of wounds healed at 6 weeks between groups.

resultsAt 6 weeks, 70% (14/20) of the dHACA-treated DFUs healed compared with 15% (3/20) treated with SOC alone. Furthermore, at 12 weeks, 85% (17/20) of the DFUs in the dHACA group healed compared with 25% (5/20) in the SOC group, with a corresponding mean time to heal of 36 and 70 days, respectively. At 12 weeks, the mean number of grafts used per healed wound for the dHACA group was 3.8 (median 3.0), and mean cost of the tissue to heal a DFU was $1400. The mean wastage at 12 weeks was 40%. One adverse event and 1 serious adverse event occurred in the dHACA group; neither was graft related. Three adverse events and 1 serious adverse event occurred in the SOC group.

conclusionAseptically processed dHACA heals diabetic foot wounds significantly faster than SOC at 6 and 12 weeks with minimal graft wastage.

Identifiers

PMID27826487
PMCPMC5096542
OpenAlexW2531214373

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.