Bactigras Pack

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Bactigras pack is a sterile, antiseptic-impregnated paraffin tulle gras dressing manufactured by Smith & Nephew. It consists of an open-weave leno cotton gauze impregnated with white soft paraffin BP containing chlorhexidine acetate BP 0.5% w/w. This combination provides a soothing, low-adherent primary wound dressing that releases broad-spectrum antiseptic activity against gram-positive and gram-negative bacteria, including MRSA, while allowing exudate to drain freely into a secondary absorbent dressing. For the clinician, Bactigras offers a reliable, ready-to-use solution for preventing and treating infection in minor burns, scalds, lacerations, abrasions, donor/recipient graft sites, and ulcerative wounds. For the patient, the low-adherent paraffin base ensures pain-free dressing changes, while the antiseptic component protects against infection, promoting faster healing and reducing complications. Available in multiple sizes from 5cm x 5cm to 10cm x 40cm, each dressing is individually wrapped and sterile.
Description

Bactigras Pack

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Prevention of Infection in Wounds at Risk
  • Primary Use: Provides a sterile, antiseptic-impregnated paraffin gauze dressing that releases chlorhexidine acetate to prevent bacterial colonization and infection in wounds susceptible to contamination.
  • How it helps: For the wound care clinician and surgeon, Bactigras delivers a proven antiseptic agent directly to the wound site—reducing the risk of infection in wounds that are clean but at risk, such as post-surgical incisions, donor sites, and traumatic wounds. For the patient, this antimicrobial protection lowers the likelihood of wound infection, which can delay healing, increase pain, and lead to more serious complications requiring additional treatment.
2. Treatment of Already Infected Wounds
  • Primary Use: Used as an adjunct to systemic antibiotic therapy for the topical management of already infected wounds, helping to reduce bacterial burden at the wound surface.
  • How it helps: For the clinician managing infected wounds, Bactigras provides targeted topical antisepsis that works alongside systemic antibiotics—addressing surface bacteria that may not be fully eradicated by oral or intravenous therapy alone. For the patient, this combined approach enhances infection control, potentially shortening the duration of infection and reducing the need for more aggressive interventions.
3. Protection of Minor Burns and Scalds
  • Primary Use: Provides a soothing, low-adherent dressing for minor burns and scalds, protecting the injured area while reducing the risk of secondary infection.
  • How it helps: For the emergency department clinician and primary care physician, Bactigras offers a sterile, non-irritating dressing that conforms to burn surfaces without sticking—allowing for comfortable wound inspection and dressing changes. For the patient with a minor burn, the soft paraffin base soothes the injured area while the antiseptic component protects against infection, reducing pain and promoting faster healing.
4. Management of Skin Loss Wounds
  • Primary Use: Used for lacerations, abrasions, donor sites, recipient graft sites, and other wounds involving skin loss where a non-adherent, antiseptic primary dressing is indicated.
  • How it helps: For the surgeon and wound care specialist, Bactigras serves as a primary wound contact layer that protects delicate granulating tissue while allowing exudate to pass through to a secondary absorbent dressing. For the patient, the low-adherent paraffin coating means dressing changes are less painful, and the antiseptic component reduces infection risk during the vulnerable healing phase.

SECONDARY & SUPPORTIVE USES

1. Protection of Graft Sites: Used to protect donor and recipient graft sites following skin grafting procedures, providing a non-adherent layer that preserves graft integrity.
2. Management of Leg Ulcers and Pressure Injuries: Used as a primary dressing for leg ulcers and pressure injuries where infection risk is present or anticipated.
3. Management of Secondary Skin Infections: Applied to infected skin conditions such as infected eczema, dermatitis, and herpes zoster lesions.
4. Post-Operative Wound Coverage: Used following minor surgical procedures requiring a sterile, antiseptic primary dressing.
5. First Aid for Minor Injuries: Included in first aid kits for managing minor cuts, grazes, and abrasions in community and home settings.
6. Under Compression Therapy: Used as a primary wound contact layer beneath compression bandages for venous leg ulcer management.
7. Pediatric Wound Care: Used for children with minor burns, cuts, and abrasions, providing gentle, non-adherent protection.
8. Diabetic Foot Ulcer Management: Used as part of wound care protocols for diabetic foot ulcers where infection prevention is critical.
9. Skin Tear Management: Provides gentle protection for skin tears in elderly patients with fragile skin.
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A sterile, antiseptic-impregnated paraffin tulle gras dressing consisting of an open-weave leno gauze impregnated with soft paraffin containing chlorhexidine acetate.
  • Designation: Bactigras, Antiseptic Paraffin Gauze Dressing, Medicated Tulle Gras, Chlorhexidine-Impregnated Dressing, Bactigras Pack, Antiseptic Gauze Dressing.
  • Key Components:
o Gauze Base: Open-weave leno weave cotton gauze that resists fraying when cut.
o Paraffin Impregnation: White soft paraffin BP that provides a soothing, low-adherent coating.
o Antiseptic Agent: Chlorhexidine Acetate BP 0.5% w/w with broad-spectrum antibacterial activity.
o Packaging: Individually wrapped, sterile, foil-laminated peel-pouch.

2. TECHNICAL & PERFORMANCE PROPERTIES

  • Active Ingredient: Chlorhexidine Acetate BP 0.5% w/w.
  • Base: White soft paraffin BP.
  • Gauze Material: Leno weave cotton gauze with interlocking threads to prevent fraying.
  • Antimicrobial Spectrum: Active against a wide range of gram-positive and gram-negative bacteria, including MRSA; inactive against spores, fungi, and viruses.
  • Sterility: Sterile; individually sealed in foil-laminated packs.
  • Sizes Available: 5cm x 5cm, 10cm x 10cm, 10cm x 30cm, 10cm x 40cm, 15cm x 20cm.
  • Pack Sizes: Available in packs of 1, 3, 5, 10, or 50 individually wrapped dressings.
  • Low-Adherent: Paraffin coating prevents dressing from sticking to the wound bed.
  • Exudate Management: Open weave allows exudate to pass through to a secondary absorbent dressing.

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Construction: Thin, flexible gauze that conforms to wound contours.
  • Appearance: Translucent, paraffin-saturated gauze.
  • Cutting: Can be cut to size without fraying due to leno weave construction.
  • Packaging: Individually wrapped sterile dressing in a peel-open foil pouch.
  • Application: Applied directly to the wound as a primary dressing; requires secondary absorbent dressing over it.
  • Wear Time: Typically changed daily or as clinically indicated; up to 7 days for some applications.

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: Class II medical device requiring 510(k) clearance.
  • Manufacturer: Smith & Nephew.
  • Sterility: Sterile; sterility maintained until package is opened.
  • Contraindications: Do not use on wounds covering more than 10% of total body surface area; do not use in patients with known hypersensitivity to chlorhexidine.
  • Precautions: Do not use oxidizing wound cleaning agents, soap, other anionic materials, or potassium iodide.
  • Pregnancy Category: Category B (animal studies show no fetal risk; no controlled human studies available).
  • Latex-Free: Contains no natural rubber latex.

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store below 30°C (86°F) in a cool, dry place; protect from direct sunlight and moisture.
  • Shelf Life: Typically 3-5 years from date of manufacture; check expiration date before use.
  • Sterility Maintenance: Do not use it if the package is opened, torn, wet, or damaged.
  • Single-Use Only: Intended for single patient, single use only; do not re-sterilize or reuse.

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: Topical prevention and treatment of wound infection in minor burns, scalds, lacerations, abrasions, skin loss wounds, donor/recipient graft sites, and ulcerative wounds.
  • Clinical Role: Essential primary wound dressing in emergency departments, burn units, operating rooms, wound care centers, dermatology practices, and home healthcare for infection-prone wounds.
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Body Surface Area Limitation: Do not use wounds covering more than 10% of total body surface area due to potential systemic absorption of chlorhexidine.
  • Allergy Screening: Confirm patient has no known hypersensitivity to chlorhexidine before use.
  • Wound Cleaning: Clean wound thoroughly before applying Bactigras; remove any previous dressing residue.
  • Secondary Dressing: Always cover Bactigras with an appropriate secondary absorbent dressing to manage exudate and secure placement.
  • Application: Apply directly to the wound surface with the smooth side facing the wound if applicable; do not stretch.
  • Change Frequency: Change dressing daily or as clinically indicated; more frequent changes may be needed for heavily exuding wounds.
  • Monitoring: Monitor for signs of allergic reaction (rash, itching, redness, difficulty breathing); discontinue use immediately if reaction occurs.
  • Do Not Use With: Avoid using oxidizing agents, soaps, or other anionic materials that may inactivate chlorhexidine.
  • Pediatric Use: Safe for use in children under medical supervision; adhere to body surface area limitation.

2. FIRST AID MEASURES

  • Allergic Reaction: If signs of hypersensitivity occur (rash, itching, swelling, difficulty breathing), remove dressing immediately, clean area, and seek medical attention.
  • Adherence to Wound: If dressing adheres to wound bed (unusual with paraffin base), moisten with sterile saline before removal to prevent tissue trauma.
  • Systemic Effects: If used on large wounds (>10% body surface area) and signs of chlorhexidine toxicity occur, remove dressing and seek medical evaluation.

3. FIRE FIGHTING MEASURES

  • Flammability: Paraffin-impregnated gauze is highly flammable; contains soft paraffin which is combustible.
  • Extinguishing Media: Use water, foam, dry chemical, or CO₂ for fire involving dressings.
  • Fire Response: Keep away from open flames, sparks, and high-heat sources; do not smoke near stored dressings. In oxygen-enriched environments, dressings may ignite more readily.