Changsha Hairun Biotechnology Co., Ltd.
PHMB alginatni preliv

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Medicinski alginatni povoj PHMB - antibakterijski hemostatik za rane z zmernim izločkom
Medicinski alginatni povoj PHMB - antibakterijski hemostatik za rane z zmernim izločkom

Medicinski alginatni povoj PHMB - antibakterijski hemostatik za rane z zmernim izločkom


Advanced Chemical Grafting Technology (Covalent Bond PHMB-Alginate Framework)
Dual Efficacy: Broad-Spectrum PHMB Antibacterial + Alginate Hemostatic & Moist Healing
High Absorbency (11× Own Weight) for Moderate Exudate Wound Management
Controlled PHMB Release - Non-Irritating to New Granulation Tissue
Sterilno za enkratno uporabo, sterilizirano z obsevanjem in certificirano po ISO 13485:2016
Soft Conformable Texture - Fits Irregular Wound Contours Perfectly
Promotes Granulation Tissue Growth & Accelerates Wound Repair
Globalna prilagoditev in regulativni tehnični dokumenti za lokalno registracijo
Predstavitev izdelka

This PHMB Alginate Dressing is a high-performance clinical-grade wound care solution that integrates the broad-spectrum antibacterial properties of polyamethylene guanidine (PHMB) with the hemostatic, moisturizing and healing benefits of medical-grade alginate—engineered via advanced chemical grafting technology for the targeted management of moderate exudate acute and chronic wounds. Ideal for hospital postoperative care, clinical wound treatment and specialized wound care centers, it is the premium choice for partial/full-thickness wounds, postoperative surgical wounds, traumatic wounds, venous leg ulcers (VLUs), pressure ulcers (PUs), diabetic foot ulcers (DFUs) and minor bleeding wounds that require antibacterial protection and moist healing support.

Crafted with innovative chemical grafting technology, PHMB molecules (0.4%–0.8% by weight) are stably bound to the alginic acid framework via covalent bonds—eliminating free PHMB and enabling precise, controlled release of the antibacterial agent. This design avoids irritation to fragile new granulation tissue, creating a safe and sustained antibacterial environment for the wound surface while delivering long-lasting inhibition of Staphylococcus aureus, Escherichia coli, Candida albicans and other common wound pathogens, with no risk of antibiotic resistance.

The natural alginate base delivers superior high absorbency (absorbing up to 11 times its own weight in wound exudate), forming a soft gel on contact with fluid to lock in exudate, maintain an optimal moist wound healing environment and promote the growth of granulation tissue—critical for accelerating wound repair. Its soft, flexible and conformable texture fits perfectly to irregular wound contours (e.g., joints, limbs, facial areas) without causing discomfort, and the sterile single-use design prevents cross-contamination. Compliant with ISO 13485:2016 and sterilized by irradiation, this dressing is a versatile and effective solution for moderate exudate wound care across all clinical settings. For global distributors and clinical partners, we offer fully customizable packaging and a complete set of regulatory-compliant technical documents, supporting seamless local product registration and market access across the EU, Middle East, Asia, Africa and all global regions.

Tehnični podatki
Postavka Tehnični podatki
Koda izdelka PHAD01 / PHAD02 / PHAD04 / PHAD06
Velikosti 5cm×5cm, 10cm×10cm, 15cm×15cm, 20cm×20cm
Osnovni material Medical-grade alginate, polyamethylene guanidine (PHMB, 0.4%–0.8% by weight)
Ključna tehnologija Chemical grafting (covalent bond PHMB-alginate framework), controlled PHMB release
Antibakterijski spekter Širok spekter (Staphylococcus aureus, Escherichia coli, Candida albicans)
Osnovna zmogljivost High absorbency (11× own weight), hemostatic, antibacterial, moist healing, non-irritating
Značilnosti oblačenja Soft conformable texture, gel-forming on exudate contact, sterile single-use, cuttable
Primerne rane Moderate exudate partial/full-thickness wounds, postoperative surgical wounds, traumatic wounds, venous leg ulcers, pressure ulcers, diabetic foot ulcers, minor bleeding wounds
Metoda sterilizacije Sterilizacija z obsevanjem (zagotovljena 100-odstotna sterilnost)
Vrsta embalaže Individualna sterilna zaprta embalaža (medicinska zaščitna folija)
Kartonska embalaža 10 kosov/škatla, klinično/bolnišnično pakiranje v razsutem stanju
Prilagodljive možnosti Custom sizes, multilingual packaging printing, branded sterile labels, cuttable sheet variants
Rok 3 leta od datuma proizvodnje (za natančen rok uporabnosti glejte embalažo)
Pogoji skladiščenja Hranite na suhem in hladnem mestu; zaščitite pred neposredno svetlobo, visokimi temperaturami in visoko vlažnostjo; pred uporabo hranite zaprto.
certificiranje Certificiran sistem vodenja kakovosti medicinskih pripomočkov po ISO 13485:2016
Skladnost z zakonodajo Podpira prilagajanje tehnične dokumentacije za globalno registracijo medicinskih pripomočkov (EU, Bližnji vzhod, JVE, Afrika itd.)
Kako uporabljati
Za klinično profesionalno uporabo (bolnišnice/centri za oskrbo ran)
Pri vseh korakih nanašanja in ravnanja upoštevajte strogo aseptično tehniko.
Clean the wound area thoroughly with sterile normal saline to remove exudate, debris and necrotic tissue; pat the surrounding skin completely dry and control any minor bleeding (the dressing’s hemostatic properties will assist with residual minor oozing).
Open the sterile packaging and remove the PHMB alginate dressing—no pre-soaking required (ready for direct application).
Apply the dressing directly to the entire wound surface, ensuring full coverage of the wound bed; for deep or cavity wounds, gently pack the dressing into the wound (do not overpack to avoid pressure on granulation tissue).
Cover the dressing with a clean, dry secondary sterile dressing (e.g., gauze, non-woven bandage) for protection and fixation; adjust fixation based on wound location and exudate volume (no tight wrapping required).
Change the dressing according to wound exudate amount and clinical condition (2-3 days for moderate exudate; daily for heavy exudate or infected wounds) or as directed by a physician. Remove the dressing gently—if it adheres to the wound bed, moisten with sterile normal saline for painless removal.
For Postoperative Home Care (Under Professional Guidance)
Wash hands thoroughly with soap and water before and after handling the dressing.
Clean the wound as instructed by a healthcare provider with sterile normal saline and pat dry gently.
Apply the PHMB alginate dressing to fully cover the wound surface; secure with a breathable, sterile secondary bandage.
Avoid getting the dressing wet during daily activities; reapply a new dressing immediately if the dressing becomes saturated or wet.
Follow the physician’s recommended dressing change schedule; contact a healthcare provider immediately if the wound shows signs of worsening (e.g., increased redness, swelling, pain or exudate).
Globalna podpora za prilagajanje in skladnost
1. Prilagodljive možnosti izdelkov in embalaže

Ponujamo prilagodljive storitve prilagajanja klinične kakovosti, prilagojene edinstvenim potrebam globalnih distributerjev, bolnišnic, centrov za oskrbo ran in zdravstvenih ustanov – z nizkim MOQ in brez nepotrebnih stroškov kalupov za standardne prilagoditve:

Prilagoditev oblog: Velikosti oblog po meri za specializirano klinično uporabo (npr. velika velikost za obsežne pooperativne rane, majhna velikost za rane na obrazu); različice oblog, ki jih je mogoče rezati, za zapiranje votlih ran
Prilagoditev sterilne embalaže: Embalaža iz sterilne folije medicinske kakovosti z večjezičnim tiskom (navodila za uporabo, logotip blagovne znamke, lokalne regulativne oznake); sterilne etikete po meri za klinično/bolnišnično blagovno znamko
Prilagoditev razsute embalaže: Oblikovanje kartona z blagovno znamko, tiskanje številke serije/kode serije, prilagoditev specifikacij klinične embalaže, izboljšana zaščita pri prevozu na dolge razdalje/po svetu (idealno za območja z visoko temperaturo/vlažnostjo)
Prilagodljivost MOQ: Nizka minimalna količina naročila za male/srednje velike distributerje; preferenčne veleprodajne cene in ekskluzivna prilagoditev za velike bolnišnice/zdravstvene ustanove
2. Tehnični dokumenti, skladni s predpisi

Naša strokovna regulativna ekipa zagotavlja celoten nabor standardiziranih tehničnih dokumentov, ki so skladni s standardom ISO 13485:2016 in regionalnimi predpisi o medicinskih pripomočkih (EU, Bližnji vzhod, Jugovzhodna Azija, Afrika, Severna Amerika itd.). Vsi dokumenti so v celoti prilagodljivi in ​​dopolnljivi, da izpolnjujejo lokalne zahteve glede registracije, z brezplačnimi posodobitvami za uskladitev s spremenjenimi regulativnimi standardi – vključno z, vendar ne omejeno na:

Dokument o certificiranju sistema vodenja kakovosti ISO 13485:2016
Tehnična specifikacija izdelka (TS) s popolnimi podatki o preskusih vpojnosti, antibakterijskih, hemostatskih in biokompatibilnih lastnosti
Poročilo o klinični validaciji in poročilo o in vitro antibakterijskem testu učinkovitosti (hitrost sproščanja PHMB in antibakterijska učinkovitost)
Potrdilo o sterilizaciji z obsevanjem in potrdilo o pregledu kakovosti serije
Podatkovni list o varnosti materiala (MSDS)
Večjezična navodila za uporabo (klinična/profesionalna/različica za domačo nego) in dokument o skladnosti označevanja
Poročilo o preskusu hemostatične in gel tvorbe delovanja (za klinično/registracijsko uporabo)

Prilagoditev in dokumentne storitve glede na vrsto stranke

Vrsta stranke Najmanjša količina naročila (MOQ) Podpora pri izdelavi/embalaži po meri Storitev tehnične dokumentacije
Mali/srednji distributerji ≥50 kartonov (ena specifikacija) Tisk na embalažo po meri + izbira velikosti (brez stroškov kalupa) Brezplačni osnovni dokumenti o globalni skladnosti + večjezični prevod
Regionalni klinični distributerji ≥200 kartonov (ena specifikacija) Popolna prilagoditev (velikosti po meri + sterilna embalaža + oblikovanje kartona) Brezplačni lokalizirani regulativni dokumenti + navodila za registracijo izdelka
Velike bolnišnice/zdravstvene ustanove ≥500 kartonov (ena specifikacija) Ekskluzivna OEM/ODM + specializirana prilagoditev kliničnih variant Brezplačni ekskluzivni regulativni dokumenti + namenski svetovalec za registracijo + letne posodobitve dokumentov
Opozorila

1. For external clinical use only; do not use on unhealed deep wounds with uncontrolled heavy bleeding, severely necrotic wounds or third-degree burns without the guidance of a physician or wound care specialist.

2. Med vsemi koraki nameščanja, rezanja in ravnanja upoštevajte aseptično tehniko, da preprečite sekundarno okužbo rane; sterilnega povoja za enkratno uporabo ne uporabljajte ponovno.

3. Discontinue use immediately and consult a physician if the wound shows signs of worsening (e.g., increased redness, swelling, pain, exudate, odor or fever) after application, or if skin irritation/allergy occurs around the wound.

4. Keep out of reach of non-clinical personnel/children; store the dressing in the original sterile packaging until use to maintain sterility, absorbency and antibacterial performance.

5. Do not use the product if the sterile packaging is damaged, torn, punctured, damp or the seal is broken—sterility and core performance cannot be guaranteed.

6. Izogibajte se stiku z očmi in ustno/nosno sluznico; če pride do nenamernega stika, takoj temeljito sperite z veliko sterilne fiziološke raztopine in se posvetujte z zdravstvenim delavcem, če draženje ne preneha.

7. This product is not suitable for individuals with a known allergy to PHMB, alginate or any other ingredients in the dressing.

8. Ne kombinirajte z drugimi lokalnimi protimikrobnimi izdelki za nego ran brez nasveta zdravnika ali kliničnega specialista za nego ran.

9. Follow the specified storage conditions; do not store in high temperature (>30℃), high humidity (>70%RH) or direct sunlight—may affect PHMB stability and alginate absorbency.

10. For cavity/deep wounds, pack the dressing gently (do not overpack); moisten with sterile normal saline before removal if the dressing adheres to the wound bed to avoid secondary damage to granulation tissue.

Kontaktni podatki
Klinično poslovno sodelovanje in svetovanje o nabavi v razsutem stanju
WhatsApp: https://wa.me/8617788969619 | https://wa.me/8619173969821
Mobilni telefon/WeChat: +86-19173969821 | +86-17788969619
Uradni klinični e-poštni naslov: [e-pošta zaščitena]  |  [e-pošta zaščitena]
Fizični naslov: 5.–8. nadstropje, A4 International Medical Instrument Industrial Park, št. 229 Hunan Lugu Road, Changsha High-tech Development Zone, Changsha, Hunan, Kitajska
Globalno prilagajanje in posvetovanje o regulativni dokumentaciji (klinična posebna linija)
Predani svetovalec (WeChat/WhatsApp): +86-19173969821
Service Scope: Dressing customization, packaging design, local product registration document preparation, PHMB efficacy verification, regulatory compliance guidance
FAQ

Q1: What is the benefit of the covalent bond PHMB-alginate framework in this dressing?

A1: The covalent bond design (via advanced chemical grafting) stably binds PHMB molecules to the alginate framework, eliminating free PHMB that can irritate new granulation tissue. It also enables precise, controlled release of PHMB over time, ensuring sustained broad-spectrum antibacterial protection for the wound without sudden release—creating a safe antibacterial environment that supports, rather than hinders, wound healing.

Q2: How does this PHMB alginate dressing work for minor bleeding wounds?

A2: The medical-grade alginate base has natural hemostatic properties—when it comes into contact with blood/wound exudate, it forms a soft gel that adheres to the wound surface, helps seal small blood vessels and stops minor oozing. At the same time, the controlled-release PHMB provides immediate antibacterial protection to prevent infection at the bleeding wound site, delivering dual hemostatic and antibacterial benefits in one step.

Q3: Why is the dressing’s 11× absorbency ideal for moderate exudate wounds?

A3: The 11× own weight absorbency is calibrated for moderate exudate wounds—it locks in sufficient exudate to keep the wound bed moist (critical for healing) without becoming oversaturated (which can lead to maceration of surrounding healthy skin). For heavy exudate wounds, the dressing can be combined with an absorbent secondary dressing or changed more frequently to maintain optimal wound conditions.

Q4: Can the dressing be cut to fit irregular wound contours, and does cutting affect its performance?

A4: Yes, the soft, flexible alginate dressing can be cut to any custom size/shape with sterile scissors (aseptic technique required) to fit irregular wound contours (e.g., joints, heels, facial wounds). Cutting does not affect the dressing’s core performance—the PHMB-alginate framework is uniformly distributed throughout the entire dressing, so all cut edges and surfaces retain full absorbency, antibacterial and hemostatic properties.

Q5: What is the difference between this PHMB alginate dressing and traditional alginate dressings?

A5: Traditional alginate dressings only provide hemostatic and moist healing benefits, with no inherent antibacterial protection—requiring combination with other antibacterial products for infected/at-risk wounds. This PHMB alginate dressing integrates broad-spectrum PHMB antibacterial protection with all the benefits of traditional alginate (hemostatic, high absorbency, gel-forming) via chemical grafting, creating an all-in-one solution that eliminates the need for multiple products and simplifies wound care.

Q6: Does the dressing form a gel on contact with exudate, and how to remove it painlessly?

A6: Yes, the alginate base forms a soft, non-adhesive gel on contact with wound exudate/blood—this gel maintains a moist wound environment and prevents the dressing from sticking to the wound bed in most cases. If the dressing does adhere (e.g., in low-exudate wounds), simply moisten the dressing with sterile normal saline for a few seconds to reactivate the gel, then remove it gently with no pain or secondary damage to granulation tissue.

Q7: Is this dressing suitable for pediatric and geriatric patients with sensitive skin/fragile wounds?

A7: Yes. The dressing features a soft, conformable and non-irritating texture (no free PHMB, controlled release formula) that is safe for pediatric and geriatric patients with sensitive skin or fragile granulation tissue. The gel-forming effect and painless removal make it ideal for patients who may be sensitive to dressing changes, and the hemostatic/antibacterial dual action is well-suited for the minor traumatic wounds common in children and pressure ulcers in the elderly.

Q8: Does this dressing require refrigeration for storage or international transportation (e.g., to the Middle East/Southeast Asia)?

A8: No. This dressing is a room temperature-stable medical device—refrigeration is not required and may cause condensation that damages sterile packaging and reduces alginate absorbency. For international transportation to high-temperature/humidity regions, we recommend insulated and moisture-proof shipping cartons to avoid prolonged exposure to extreme heat (>40℃) and high humidity (>70%RH), aligning with our storage guidelines (dry, cool, protected from light).

Q9: What is the recommended dressing change frequency for different wound types?

A9: For postoperative surgical wounds (moderate exudate): change every 2-3 days; for chronic ulcers (VLUs/DFUs/PUs, moderate exudate): change every 2 days; for minor traumatic/bleeding wounds: change daily until bleeding stops, then every 2-3 days; for mildly infected moderate exudate wounds: change daily to monitor wound condition and maintain antibacterial efficacy. Always adjust based on clinical wound condition and exudate volume as directed by a physician.

Q10: Do you provide clinical training for healthcare staff on using this dressing for cavity/deep wound packing?

A10: Yes. For bulk clinical procurement by hospitals/wound care centers, we provide free online clinical application training (conducted by our wound care specialists) covering aseptic application, custom cutting, gentle cavity/deep wound packing, dressing removal techniques and troubleshooting for moderate exudate wounds. We also provide a printable multilingual clinical application guide (with step-by-step images) for on-site staff training and reference.

POVPRAŠEVANJE