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hydrophilic foam dressing
Busse Hospital Disposables
Summary: Hydrophilic foam dressing by Busse Hospital Disposables is primarily used for wound management. Key evidence highlights its antimicrobial properties and potential to improve healing.
FDA Clearance Information
Pathway
510K
Number
K953019 ↗
Decision Date
September 15, 1995
Product Code
KMF
Device Class
Class 1
Evidence
419 studies
The hydrophilic foam dressing was cleared by the FDA via the 510k pathway on September 15, 1995. It is manufactured by Busse Hospital Disposables and classified as a Class 1 device.
What It Is
The hydrophilic foam dressing is designed to manage wound exudate and maintain a moist wound environment, which is conducive to healing. It is used in various wound care applications, including pressure ulcers and surgical wounds.
Clinical Applications
Commonly used in the management of acute and chronic wounds, the hydrophilic foam dressing is particularly beneficial in scenarios requiring moisture balance and protection against infection.
Evidence Summary
The literature includes 12 studies, comprising randomized controlled trials and other study types, conducted between 2021 and 2025. These studies explore the dressing's antimicrobial properties and wound healing efficacy.
Reported Outcomes
Published studies report that hydrophilic foam dressings, particularly those enhanced with antimicrobial agents like propolis and N. sativa oil, show promise in reducing infection rates and improving wound healing times. The studies highlight the dressing's ability to maintain a moist environment conducive to healing.
Safety Profile
Reported complications include potential allergic reactions to components such as propolis. However, the overall safety profile is favorable, with minimal adverse events documented in the literature.
Evidence Limitations
The evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term efficacy and safety across diverse patient populations.
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 hydrophilic foam dressing?
The dressing is indicated for use in managing wounds that require moisture balance, such as pressure ulcers, surgical wounds, and other acute or chronic wounds.
What outcomes have been reported in clinical studies?
Studies have reported improved wound healing times and reduced infection rates when using hydrophilic foam dressings, especially those with added antimicrobial agents.
What complications have been reported?
Safety data indicate minimal complications, with some reports of allergic reactions to components like propolis.
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.