Evidence map›Paper›PMID 29381543›Full record

Trial reportDermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]2018

First Safety and Performance Evaluation of T45K, a Self-Assembling Peptide Barrier Hemostatic Device, After Skin Lesion Excision.

George Rahmani, Jayne Prats, Terrence Norchi, Steven Kates, Veronica McInerney, Jack Woods, Jack Kelly

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06028386 (A Prospective Pilot Study Evaluating Wound Closure With the Application of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 34% 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.

NCT06028386 naunknown statusnot on this mapstarted 2023, after this paper: background citation

A Prospective Pilot Study Evaluating Wound Closure With the Application of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers

TypeinterventionalSponsorArch TherapeuticsRan2023 to 2024Enrolled60ConditionsNon-healing Wound, Diabetic Foot UlcerArmsAC5® Advanced Wound System, Fibracol Plus Collagen Dressing
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Self-assembling peptide scaffolds in the clinic.NPJ Regenerative medicine · 2021
    Review
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 2 institutions in 1 country.

George RahmaniDepartment of Plastic and Reconstructive Surgery, Galway University Hospitals, Galway, Republic of Ireland.
Jayne PratsArch Therapeutics, Inc., Framingham, MA.
Terrence NorchiArch Therapeutics, Inc., Framingham, MA.
Steven KatesArch Therapeutics, Inc., Framingham, MA.
Veronica McInerneyHRB Clinical Research Facility, National University of Ireland, Galway, Republic of Ireland.
Jack WoodsDepartment of Plastic and Reconstructive Surgery, Galway University Hospitals, Galway, Republic of Ireland.
Jack KellyGalway University Hospital, Galway, Republic of Ireland.
University Hospital Galway · IEOllscoil na Gaillimhe – University of Galway · IE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe self-assembling peptide barrier T45K (SAPB-T45K) is an oligopeptide that rapidly forms a biocompatible hemostatic barrier when applied to wounds.

objectiveEvaluate safety and performance of SAPB-T45K in cutaneous surgery. MATERIALS AND

methodsIn this single-blind study, after sequential shave excision of 2 lesions, wounds were randomized (intrapatient) to SAPB-T45K or control treatment. Safety was assessed at treatment, Day 7, and Day 30. Performance was evaluated using time to hemostasis (TTH) and ASEPSIS wound scores, with a subgroup analysis for patients with or without antiplatelet therapy.

resultsEach of 46 patients (10 [22%] with antiplatelet therapy) received randomized SAPB-T45K or control treatment for 2 wounds. Safety assessments were similar, and ASEPSIS scores reflected normal healing in both wound groups. SAPB-T45K demonstrated significantly faster median TTH (24.5 [range, 7-165] seconds) compared with control (44 [10-387] seconds), for a 41% median TTH reduction (18 [95% confidence interval, 7-35] seconds, p < .001). SAPB-T45K provided an identical median TTH of 24 seconds, regardless of antiplatelet therapy. Control median TTH was 90 and 40 seconds for patients taking or not taking antiplatelet therapy, respectively.

conclusionsSAPB-T45K provided significantly faster median TTH versus control, especially with antiplatelet therapy, and safety profiles were similar.

Indexed as

AdultAgedAged, 80 and overAmino Acid MotifsBiocompatible MaterialsDermatologic Surgical ProceduresFemaleHemostasis, SurgicalHumansKeratosis, SeborrheicMaleMiddle AgedOligopeptidesPostoperative HemorrhageSingle-Blind MethodWound HealingBiocompatible MaterialsOligopeptides

Identifiers

PMID29381543
PMCPMC6039376
OpenAlexW2793504946

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.