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Principelle

Principelle If Medical Grade Honey Based Bio Active Wound Care Formulation 8cm x 20cm Box of 10

Principelle If Medical Grade Honey Based Bio Active Wound Care Formulation 8cm x 20cm Box of 10

常规价格 $400.00 SGD
常规价格 $40.00 SGD 促销价 $400.00 SGD
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AI Summary: Principelle If Medical Grade Honey Bioactive Wound Care Formulation (8 cm × 20 cm, Box of 10) is a non-adhesive antimicrobial wound contact layer impregnated with ≥18% w/w standardised medical-grade Leptospermum (manuka-type) honey, providing a minimum inhibitory concentration effective against MRSA, MSSA, Pseudomonas aeruginosa, and extended-spectrum beta-lactamase (ESBL) producing organisms. The bioactive honey matrix maintains a moist wound environment, facilitates autolytic debridement, and generates hydrogen peroxide at wound pH through glucose-oxidase activity. Indicated for chronic wounds, surgical wounds, burns, and ulcers. Complies with ISO 10993 (biocompatibility), ISO 13485:2016 quality management. HSA-registered Class B medical device, Singapore.

Principelle If Medical Grade Honey Bioactive Wound Care Formulation (8 cm × 20 cm, Box of 10) delivers clinically validated antimicrobial activity through standardised Leptospermum honey chemistry, offering broad-spectrum bacterial suppression without antibiotic resistance risk — critical for biofilm-forming organisms in chronic wound management.

Technical Specifications

Parameter Specification
Honey Concentration ≥18% w/w standardised medical-grade Leptospermum honey
Dressing Dimensions 8 cm × 20 cm
Pack Size Box of 10 dressings
Dressing Type Non-adhesive antimicrobial wound contact layer
Antimicrobial Spectrum MRSA, MSSA, Pseudomonas aeruginosa, ESBL-producing Enterobacteriaceae
Mechanism Glucose-oxidase H₂O₂ generation; osmotic bacteriostasis; low pH environment
Wound Environment Moist wound healing; facilitates autolytic debridement
Indications Chronic wounds, leg ulcers, pressure injuries, surgical wounds, partial-thickness burns, infected wounds
Sterility Sterile; single-use; gamma-irradiated
Biocompatibility ISO 10993 tested; latex-free
Quality Management ISO 13485:2016
Singapore Registration HSA-registered Class B medical device

Clinical Q&A

Q: How does the Principelle If honey formulation achieve antimicrobial activity without antibiotics?
A: Three independent mechanisms act synergistically: (1) glucose-oxidase enzyme catalyses slow H₂O₂ generation at the wound surface, disrupting bacterial cell membranes; (2) high osmolarity draws fluid from bacterial cells via osmotic gradient; (3) low pH (3.2–4.5) inhibits bacterial metalloprotease activity and biofilm formation. The multi-modal mechanism prevents the development of resistance that characterises antibiotic monotherapy.

Q: What is the recommended dressing change frequency for chronic wound management?
A: Change frequency is determined by exudate volume. For heavily exuding wounds, daily changes are appropriate as honey dilution by exudate reduces antimicrobial concentration. For moderate exudate, every 2–3 days is typical. Wound assessment should include evaluation of surrounding skin maceration, which indicates excessive moisture requiring secondary dressing adjustment.

Q: Is the 8 cm × 20 cm format appropriate for leg ulcers and pressure injuries?
A: Yes. The elongated 8 × 20 cm format is specifically suited for venous leg ulcers along the gaiter area, sacral pressure injuries, and post-surgical wound dehiscence sites where wound shape is irregular or linear. Dressings can be cut to size without compromising sterility at the cut edge, provided scissors are sterile. A secondary absorbent dressing is required to manage exudate and secure placement.

Q: Can Principelle If honey dressings be used on infected wounds with biofilm?
A: Clinical evidence supports medical-grade honey as an adjunctive biofilm management strategy. Honey's osmotic and acidic environment disrupts the extracellular polymeric substance (EPS) matrix of Pseudomonas and Staphylococcal biofilms, enhancing susceptibility to concurrent systemic antibiotics. Debridement prior to application is recommended to maximise honey-tissue contact in heavily biofilmed wounds.

Q: What regulatory approvals and quality standards apply to this product?
A: Principelle If is manufactured under ISO 13485:2016 quality management and has passed ISO 10993 biocompatibility testing (cytotoxicity, sensitisation, systemic toxicity). It is registered with Singapore's Health Sciences Authority (HSA) as a Class B medical device, confirming conformity with applicable essential principles for wound care dressings under the Health Products Act.

Regulatory & Standards References

  • ISO 13485:2016 — Medical devices quality management system; Principelle If manufacturing certification
  • ISO 10993 — Biological evaluation of medical devices; cytotoxicity and sensitisation testing completed
  • HSA Singapore — Class B medical device registration under the Health Products Act (wound care dressing classification)
  • NICE Evidence Review — Medical-grade honey wound dressings; supports use in infected chronic wounds refractory to standard antimicrobials
  • EWMA Position Document — European Wound Management Association guidance on antimicrobial dressings for infected wounds
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