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dermaphylyx hydrophilic foam wound dressing
Dermaphylyx
Summary: The Dermaphylyx Hydrophilic Foam Wound Dressing is a medical device designed for wound management. It is primarily used to maintain a moist wound environment and promote healing. Key evidence highlights its antimicrobial properties and effectiveness in wound healing.
FDA Clearance Information
Pathway
510K
Number
K991920 ↗
Decision Date
August 12, 1999
Product Code
KMF
Device Class
Class 1
Evidence
419 studies
The Dermaphylyx Hydrophilic Foam Wound Dressing was cleared through the FDA 510(k) pathway on August 12, 1999. It is manufactured by Dermaphylyx and classified as a Class 1 device under product code KMF.
What It Is
The Dermaphylyx Hydrophilic Foam Wound Dressing is a polyurethane-based dressing designed to manage wound exudate and maintain a moist environment conducive to healing. It is intended for use in various wound care settings, providing both absorption and antimicrobial properties.
Clinical Applications
This device is commonly used in clinical scenarios involving chronic wounds, pressure ulcers, and post-surgical wounds. It is particularly useful in managing wounds with moderate to heavy exudate, where maintaining a moist environment is crucial for healing.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2022 to 2025, focusing on the device's efficacy and safety in wound management.
Reported Outcomes
Published studies report that the Dermaphylyx Hydrophilic Foam Wound Dressing effectively reduces wound infection rates and accelerates healing. The incorporation of antimicrobial agents like Nigella sativa oil and propolis has shown promising results in enhancing the dressing's therapeutic properties. The device's ability to manage wound microclimate and exudate is also highlighted.
Safety Profile
Reported complications include minimal adverse reactions, primarily related to skin irritation or allergic responses. Overall, the device is considered safe with a low incidence of significant complications.
Evidence Limitations
Current evidence is limited by small sample sizes and short follow-up durations. Further research is needed to establish long-term outcomes and compare the device's efficacy with other advanced wound dressings.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Dermaphylyx Hydrophilic Foam Wound Dressing?
The device is indicated for use in managing chronic wounds, pressure ulcers, and post-surgical wounds, particularly those with moderate to heavy exudate.
What outcomes have been reported in clinical studies?
Studies report reduced infection rates and accelerated healing, with antimicrobial properties enhancing therapeutic effects.
What complications have been reported?
Reported complications include minimal skin irritation and allergic responses, with an overall low incidence of significant adverse events.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.