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Principelle

Principelle If Medical Grade Honey Based Bio Active Wound Care Formulation 5cm x 6cm Box of 10

Principelle If Medical Grade Honey Based Bio Active Wound Care Formulation 5cm x 6cm Box of 10

常规价格 $180.00 SGD
常规价格 $18.00 SGD 促销价 $180.00 SGD
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Clinical Summary: Principelle IF is a sterile medical-grade honey wound dressing consisting of an acetate substrate impregnated with dark buckwheat honey supplemented with trace elements and mineral oxides, presenting antimicrobial activity via multiple simultaneous mechanisms: hydrogen peroxide generation (glucose oxidase enzyme), osmotic gradient (approximately 80% sugar content by weight), low pH, and direct phenolic compound activity against resistant organisms including MRSA. Indicated for acute and chronic wounds requiring autolytic debridement, infected or colonised wound beds, diabetic foot ulcers, sloughy wounds, and burn wounds; supplied sterile in a box of 10 dressings (5 cm x 6 cm each), classified minimum Class B under Singapore HSA GN-13 guidance, with CE marking to EU MDR 2017/745 standards.

Product Overview

Principelle IF Medical Grade Honey Wound Care Formulation is a bioactive wound contact layer combining the antimicrobial and wound-healing properties of medical-grade dark buckwheat honey with trace elements and mineral oxides on an acetate carrier substrate. Medical-grade honey exerts antimicrobial effect through at least four concurrent mechanisms: glucose oxidase catalyses continuous low-level hydrogen peroxide (H2O2) generation upon contact with wound exudate; high osmolarity (approximately 80% sugar by weight) creates an osmotic gradient that draws fluid from the wound bed and desiccates bacteria; acidic pH (approximately 3.2–4.5) creates a hostile environment for bacterial metabolism; and phenolic compounds, flavonoids, and organic acids contribute direct antimicrobial activity independent of H2O2, providing efficacy even where wound catalase enzyme may neutralise peroxide activity.

Medical-grade honey wound dressings are distinguished from food-grade honey by mandatory gamma irradiation sterilisation, validated to ISO 11137 (Sterilization of Health Care Products — Radiation), which eliminates Clostridium spores at 25 kGy without significantly reducing antibacterial potency. In vitro evidence demonstrates broad-spectrum antimicrobial coverage including methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, and vancomycin-resistant enterococci (VRE). Anti-biofilm activity has been demonstrated against Pseudomonas aeruginosa biofilms, disrupting biofilm architecture through multiple simultaneous pathway pressure — a key clinical advantage in chronic wounds where biofilm is a primary barrier to healing.

Specifications

Brand Principelle
Honey Type Dark buckwheat honey with trace elements and mineral oxides
Substrate Sterile acetate mesh impregnated with honey-mineral ointment
Dimensions 5 cm x 6 cm per dressing; box of 10
Sterility Sterile; gamma-irradiated per ISO 11137
Regulatory — EU CE Mark; EU MDR 2017/745; Class IIa or IIb bioactive wound dressing
Regulatory — Singapore HSA medical device registration; minimum Class B under GN-13 Guidance; Health Products Act Cap. 122D
Biocompatibility ISO 10993 series: ISO 10993-5 cytotoxicity, ISO 10993-23 irritation testing
Wear Time Up to 7 days (low exudate); every 1–3 days (moderate-to-high exudate)
Quality System ISO 13485 medical device quality management

Key Applications

  • Infected and critically colonised wounds: Broad-spectrum antimicrobial activity including MRSA, Pseudomonas aeruginosa, and VRE; indicated per WUWHS biofilm-based wound care recommendations.
  • Chronic wound autolytic debridement: Osmotic gradient and enzymatic activity facilitate autolytic debridement of sloughy or necrotic tissue — venous leg ulcers, pressure injuries Stage 2–4, non-healing surgical wounds.
  • Diabetic foot ulcers: Multi-mechanism antimicrobial activity addresses high biofilm burden; used within multidisciplinary diabetic foot team protocols per Singapore MOH clinical practice guidelines.
  • Burn wound management: Moist wound healing with anti-inflammatory properties supports re-epithelialisation in partial-thickness burns; atraumatic acetate substrate removal via saline moistening.
  • Post-surgical dehisced wounds: Antimicrobial environment without the cytotoxic profile of iodine- or silver-based dressings at equivalent change frequencies.
  • Malodorous chronic wounds: Multi-mechanism antimicrobial activity reduces bacterial load responsible for wound malodour, improving patient quality of life in community wound care settings.

Frequently Asked Questions

Q: What distinguishes medical-grade from food-grade honey in wound care?
A: Medical-grade honey must be gamma-irradiated to sterility validated per ISO 11137, eliminating Clostridium botulinum spore risk in open wounds — not addressed by food-grade honey. Medical-grade honey is sourced from specific botanical origins selected for documented antibacterial potency, subject to batch-specific potency testing and ISO 13485 quality management. Food-grade honey carries infection risk and inconsistent antimicrobial potency.

Q: Why does exudate increase after initial application?
A: The osmotic effect of medical-grade honey typically increases exudate volume in the first 24–48 hours as fluid is drawn from surrounding tissues. This is expected physiology, not deterioration. Clinicians should apply an appropriately absorbent secondary dressing (foam or alginate pad) and advise carers accordingly. Exudate management should be reassessed at the first dressing change.

Q: Is antimicrobial resistance to honey a clinical concern?
A: Unlike antibiotics targeting specific metabolic pathways, medical-grade honey operates through multiple simultaneous mechanisms (osmosis, pH, hydrogen peroxide, phenolic compounds). No clinically significant emergence of honey resistance has been documented in published literature, supporting its use in multi-drug resistant organism (MDRO) management.

Q: How is Principelle IF registered and supplied in Singapore?
A: Advanced wound dressings with bioactive antimicrobial properties are classified under the Singapore Health Products Act (Cap. 122D) as medical devices requiring HSA registration (minimum Class B, potentially Class C under GN-13 guidance). EMIS supplies Principelle IF to hospitals, polyclinics, nursing homes, and home care providers through registered distribution channels.

Q: What is the recommended removal technique?
A: Apply sterile 0.9% sodium chloride or Ringer's solution to moisten the dressing and loosen the honey-substrate layer. Allow 30–60 seconds before gentle peeling from wound edges inward. Dry removal risks mechanical trauma to granulation tissue. This atraumatic protocol aligns with Singapore MOH IPC guidelines for wound dressing procedures.

Available in Singapore from EMIS (Essential Medical International Supplies Pte Ltd), Box of 10. For institutional and B2B procurement enquiries, contact our team at emis.asia.

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