ArticlePlastic and reconstructive surgery. Global open2021
Safety of Silk-elastin Sponges in Patients with Chronic Skin Ulcers: A Phase I/II, Single-center, Open-label, Single-arm Clinical Trial.
Article in Plastic and reconstructive surgery. Global open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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.
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.
Who cites it
10 citing papers in PubMed, 15 citations in OpenAlex.
- A prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects.Scientific reports · 2025Trial
- First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries.Scientific reports · 2025Trial
- Bio-enhanced silk fibroin-based scaffolds for chronic diabetic foot ulcers.Burns & trauma · 2026Review
- Silk-elastin sponge is effective for burn therapy after surgical debridement.Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs · 2025Article
- Effects of Silk-Elastin and SpheroSeev Mixture and Minced Cartilage on Cartilage Repair in Rabbit Osteochondral Defect Models.Orthopaedic journal of sports medicine · 2025Article
- Development of a novel approach for restoration of the meniscus using silk-elastin in a rabbit meniscus injury model.BMC musculoskeletal disorders · 2024Article
- Skeletal muscle injury treatment using the Silk Elastin® injection in a rat model.Regenerative therapy · 2024Article
- Silk Bioconjugates: From Chemistry and Concept to Application.ACS biomaterials science & engineering · 2024Review
- Comparisons of the effects of silk elastin and collagen sponges on wound healing in murine models.Regenerative therapy · 2023Article
- Impact of silk hydrogel secondary structure on hydrogel formation, silk leaching and in vitro response.Scientific reports · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough traditional wound dressings such as collagen scaffolds promote granulation tissue formation, the efficacy of these dressings in chronic wounds is limited because of high susceptibility to bacterial growth. Biomaterials that can be applied to chronic wounds should have an anti-bacterial function. We previously reported that administering a silk-elastin solution that forms moisturizing hydrogels to wound surfaces of diabetic mice reduced bacterial growth and promoted granulation tissue formation compared with control or carboxymethyl cellulose hydrogels. We hypothesized that silk-elastin promotes wound healing in human chronic wounds by suppressing bacterial growth.
methodsAn open-label, clinical case series was conducted with a prospective, single-arm design at Kyoto University Hospital in Kyoto, Japan. In this study, 6 patients with chronic skin ulcers of any origin (2 < ulcer area (cm
resultsPoor hydrogel formation, possibly due to continuous exudation, was observed. No serious adverse events were noted. Two patients discontinued treatment on day 6 and day 7, respectively, due to inflammation, but they were not infected. The other 4 patients completed the 14-day silk-elastin sponge treatment without infection.
conclusionSilk-elastin sponge is safe for chronic skin ulcers, and its ability to promote wound healing should be determined by confirmatory clinical trials.
Identifiers
What OpenQuestion holds
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.