Body surface conduit fixing device – Type C

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Description

Body Surface Conduit Fixing Device – Type C

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Enclosed Wrap-Around Fixation for Drainage Tubes
  • Primary Use: Provides a sterile, single-use adhesive fixation device with an enclosed wrap-around strap or flap design specifically engineered to securely hold chest, abdominal, and pelvic cavity drainage tubes, as well as indwelling catheters, without the need for sutures or additional tape .
  • How it helps: For the thoracic surgeon, general surgeon, and bedside nurse, the Type C device features an integrated enclosed fixation strap that wraps completely around the drainage tube, creating a snug, 360-degree grip that prevents the tube from sliding in or out of the patient’s body. Unlike open-channel devices, the enclosed design ensures the tube remains centered and secure even under significant tension. For the patient recovering from thoracic or abdominal surgery, this secure fixation prevents the painful sensation of the drainage tube tugging at the insertion site and significantly reduces the risk of accidental tube dislodgement, which could lead to pneumothorax, surgical site infection, or the need for emergency tube replacement.
2. High-Tensile Strength for Heavy Drainage Applications
  • Primary Use: Engineered to withstand high pull forces – tested to bear up to 3 kilograms (approximately 6.6 pounds) of tension – making it suitable for securing heavier drainage systems and for patients who are ambulatory or prone to movement during sleep .
  • How it helps: For the post-operative care team and physical therapist, the Type C device’s superior tensile strength provides confidence that the drainage system will remain securely attached even when the patient is walking, turning in bed, or performing prescribed breathing exercises. For the patient with chest tubes following lung surgery or abdominal drains after gastrointestinal surgery, this high-strength fixation allows for earlier mobilization, reducing the risk of post-operative complications such as deep vein thrombosis and pneumonia, while minimizing the fear of pulling out the drain during necessary movement.
3. Non-Woven Fabric with Pressure-Sensitive Adhesive
  • Primary Use: Constructed from soft, breathable non-woven fabric coated with medical-grade pressure-sensitive adhesive that provides reliable skin adhesion while minimizing the risk of contact dermatitis and skin irritation even with extended wear .
  • How it helps: For the wound care nurse and dermatology liaison, the non-woven fabric backing offers excellent conformability to body contours, moving with the patient rather than pulling against the skin. The pressure-sensitive adhesive activates with simple finger pressure, creating an immediate bond without requiring additional heat or chemical activators. For the patient with sensitive skin, a history of radiation therapy, or prolonged hospitalization, this gentle but reliable adhesive reduces the risk of Medical Adhesive-Related Skin Injury (MARSI and allows for comfortable extended wear without the itching and redness associated with harsher adhesives.
4. Integrated Fixation Strip for Multiple Conduit Sizes
  • Primary Use: Features a multi-layer design that includes a detachable or repositionable fixation strip that can be adjusted to accommodate various catheter and drainage tube diameters, reducing inventory complexity for hospital supply chains .
  • How it helps: For the central supply manager and intensive care unit (ICU) clinician, the Type C device’s adjustable fixation strip eliminates the need to stock multiple sizes for different tube diameters. The same device can secure small-bore central line catheters, medium-sized percutaneous drains, and larger chest tubes simply by adjusting the tension on the wrap-around strap. For the patient, this universal design ensures that the correct fixation device is always available at the bedside, reducing delays in securing newly placed drains and minimizing the risk of temporary taping methods failing before the proper device arrives.
5. Breathable Construction for Insertion Site Visibility
  • Primary Use: Designed with a permeable, high-permeability non-woven textile that allows the skin to breathe while providing a transparent or fenestrated window for continuous visualization of the catheter insertion site .
  • How it helps: For the infection control practitioner and bedside nurse, the high-permeability fabric reduces moisture buildup beneath the dressing, preventing maceration of the percutaneously that can lead to fungal infections. The integrated site window enables daily assessment for signs of infection (erythema, swelling, drainage, odor) without requiring the removal of the fixation device. For the patient, this means fewer dressing changes, less pain from adhesive removal, and earlier detection of potential complications, leading to better clinical outcomes.

SECONDARY & SUPPORTIVE USES

1. Chest Tube Securement Following Thoracic Surgery: Used to anchor thoracostomy tubes placed for pneumothorax, hemothorax, or post-operative drainage following lung resection, ensuring the tube remains at the correct depth within the pleural space .
2. Abdominal Drain Fixation After Gastrointestinal Surgery: Secures surgical drains (Jackson-Pratt, Blake, or Hemovac) exiting the abdomen following bowel resection, gastrectomy, or pancreatic surgery, preventing accidental pullout during patient movement .
3. Pelvic Drain Management Following Urologic or Gynecologic Surgery: Used to stabilize drains placed in the pelvic cavity after prostatectomy, cystectomy, or hysterectomy, where patient mobility is encouraged for rapid recovery .
4. Central Venous Catheter (CVC) Securement: Anchors central lines placed in the jugular, subclavian, or femoral veins for long-term antibiotic therapy, chemotherapy, or parenteral nutrition .
5. Peripherally Inserted Central Catheter (PICC) Line Stabilization: Secures PICC lines at the exit site on the upper arm, preventing pistoning that can lead to phlebitis or line migration .
6. Hemodialysis Catheter Fixation: Used to stabilize large-bore dialysis catheters exiting the chest or groin, where high blood flow rates create significant torque on the line.
7. Continuous Ambulatory Peritoneal Dialysis (CAPD) Catheter Securement: Anchors peritoneal dialysis catheters to the abdominal wall, preventing tension on the subcutaneous cuff and reducing the risk of exit-site infection.
8. Epidural Catheter Fixation for Pain Management: Secures epidural catheters used for post-operative analgesia or labor pain relief, preventing dislodgement that would interrupt pain control .
9. Nasogastric and Orogastric Tube Securement: Used to affix feeding or decompression tubes to the nose or cheek, preventing accidental removal that requires radiographic confirmation for re-placement .
10. Tracheostomy Tube Stabilization: Functions as a securement device for tracheostomy tube flanges, preventing tube movement that could cause tracheal injury or accidental decannulation.
11. External Ventricular Drain (EVD) Securement: Anchors cerebral spinal fluid drainage systems, ensuring the critical zero-reference level remains stable to prevent over-drainage or under-drainage.
12. Wound Vacuum-Assisted Closure (VAC) Tubing Securement: Used to hold negative pressure wound therapy tubing in place, preventing tension on the adhesive drape that could break the vacuum seal.
13. Post-Mastectomy Drain Management: Secures surgical drains placed in the axilla or chest wall following breast cancer surgery, allowing patients to begin range-of-motion exercises without fear of drain pullout.
14. Biliary Drain and Percutaneous Drain Fixation: Anchors transhepatic biliary drains or percutaneous abscess drainage catheters that must remain in place for extended periods.
15. Pediatric Catheter Securement: Provides a gentle, secure hold for catheters and drains in pediatric patients, where smaller anatomy and higher activity levels increase the risk of accidental dislodgement.
16. Home Healthcare Line Management: Used by visiting nurses to secure central lines and drainage catheters for patients receiving home infusions or managing surgical drains after hospital discharge.
17. Rehabilitation and Physical Therapy Support: Enables patients with indwelling catheters or drains to participate actively in physical therapy and ambulation without fear of line pullout .
18. Long-Term Care Facility Catheter Stabilization: Provides durable, extended-wear securement for residents with chronic indwelling catheters, reducing the frequency of dressing changes and associated skin trauma.
19. Geriatric Skin Protection: The breathable, hypoallergenic non-woven fabric is specifically designed for use on fragile, thin, or easily damaged skin common in elderly patients .
20. Pre-Hospital and Emergency Department Securement: Quickly applied in trauma bays to stabilize chest tubes and central lines before patient transport to radiology or the intensive care unit.
21. Operating Room Post-Procedure Dressing: Applied immediately after drain or catheter placement while the patient is still under anesthesia, ensuring secure fixation before the patient wakes and begins moving.
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A sterile, single-use adhesive catheter fixation device consisting of a non-woven fabric base coated with pressure-sensitive adhesive, featuring an enclosed wrap-around strap or flap for securing medical conduits to the body surface .
  • Designation: Body Surface Conduit Fixing Device - Type C, Catheter Stabilization Device Type C-04, Catheter Fixation Device, Drainage Tube Holder, Tube Securement Dressing, Conduit Fixation Dressing .
  • Key Components:
    • Adhesive Base: Soft, breathable non-woven fabric coated with medical-grade pressure-sensitive adhesive .
    • Fixation Strap: Enclosed wrap-around strap or flap that secures the conduit in place; repositionable for adjustability .
    • Release Liner: Silicone-coated or paper liner protecting the adhesive surface prior to application.
    • Optional Fenestrated Window: Some versions include a transparent area for site visualization.
    • Size Variants: Available as Type C-02, Type C-04, and others for different clinical applications .

2. TECHNICAL & PERFORMANCE PROPERTIES

  • Adhesive Type: Medical-grade pressure-sensitive adhesive (PSA) with high permeability .
  • Tensile Strength: Tested to withstand up to 3 kilograms (approximately 6.6 pounds) of pull force without detachment .
  • Material: Non-woven fabric with high permeability for breathability .
  • Fixation Mechanism: Enclosed wrap-around grip that conforms to conduit diameter .
  • Skin Sensitivity: Low-sensitization formulation to minimize allergic reactions .
  • Sterility: Sterile, single-use; gamma irradiation or ethylene oxide sterilized.
  • Latex Content: Manufactured without natural rubber latex.
  • Conformability: Soft, flexible textile that fits body contours perfectly and is not affected by patient position .
  • Application: Peel-and-stick; requires removal of release paper, placement of adhesive base, then securing of the fixation strap over the conduit .
  • Wear Time: Designed for extended wear; replace per facility protocol or when soiled or loosened.

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Construction: Multi-layer design comprising (from skin outward): release liner, pressure-sensitive adhesive, non-woven fabric base, and integrated fixation strap.
  • Breathability: High permeability fabric prevents moisture accumulation beneath the dressing .
  • Flexibility: Soft, conformable textile that moves with the patient without restricting mobility .
  • Adjustability: Fixation strap can be repositioned to achieve appropriate tension for different conduit sizes .
  • Portability: Individually packaged in sterile peel-pouches; available in bulk boxes.
  • Disposal: Discard as medical waste after single use.

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: Class I or Class II Medical Device depending on market and specific claims.
  • Sterility Assurance: Sterility Assurance Level (SAL of 10^-6.
  • Biocompatibility: ISO 10993 tested for cytotoxicity, sensitization, and skin irritation .
  • Latex-Free: Standard in modern fixation devices.
  • Hypoallergenic: Low-sensitization adhesive formulated to minimize allergic contact dermatitis .
  • Product Codes: Available in various specifications including C02 (Type C-02) and other configurations .

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store in a cool, dry location at room temperature; protect from humidity, direct sunlight, and extreme heat.
  • Shelf Life: Typically 2-3 years from date of manufacture.
  • Inspection: Do not use if package is opened, torn, wet, or damaged.
  • Skin Preparation: Clean site with appropriate antiseptic (chlorhexidine or alcohol) and allow to dry completely before application .
  • Application Instructions: Select location below the drainage site, avoid scars or skin folds, remove release paper, apply adhesive base, open fixation strap, secure conduit, and check hold by gently pulling the catheter .
  • Removal: Use medical adhesive remover if needed to prevent skin stripping; remove by gently pulling parallel to skin surface.

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: Fixation and stabilization of chest tubes, abdominal drains, pelvic drains, indwelling catheters, central venous catheters (CVCs), and peripherally inserted central catheters (PICCs) to the body surface .
  • Clinical Role: Essential post-operative and critical care device in thoracic surgery, general surgery, urology, gynecology, intensive care units, oncology departments, and home healthcare for drainage tube and catheter management.
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Avoid Scar Tissue: Select application site below the drainage exit site and avoid scar-ruffle-place (scarred or wrinkled skin areas) to ensure optimal adhesion .
  • Do Not Over-Tighten: Secure the fixation strap with gentle pressure; over-tightening may compromise circulation or cause tissue damage.
  • Site Inspection: Regularly inspect the insertion site through the dressing (if visible) for signs of infection, drainage, or skin breakdown.
  • Check Hold: After application, gently pull the catheter to verify secure fixation .
  • Do Not Reuse: Intended for single patient use only; do not re-sterilize or reuse.
  • Skin Integrity: Remove immediately if signs of allergic reaction (rash, itching, blistering) or skin breakdown develop.

2. FIRST AID MEASURES

  • Adhesive Reaction: If skin redness, itching, or blistering occurs under the adhesive base, remove the device, cleanse the skin with mild soap and water, and apply a mild topical steroid if ordered. Consider switching to a silicone-based adhesive device for future applications.
  • Skin Tear: If removal causes skin stripping (MARSI, apply medical adhesive remover to the remaining adhesive, gently roll the device off, and apply an appropriate wound dressing to the affected area.
  • Catheter Dislodgement: If the catheter becomes partially dislodged despite the fixation device, do not attempt to re-advance it. Cover the insertion site with sterile gauze, secure the catheter in its current position, and notify the physician immediately.

3. FIRE FIGHTING MEASURES

  • Flammability: Non-woven fabric and adhesive components are combustible; may burn if exposed to flame or high heat.
  • Extinguishing Media: Use water, foam, dry chemical, or carbon dioxide for fire involving dressing materials.
  • Fire Response: No special fire hazards beyond typical combustible medical materials.