Bi-Fix™ Surgical Incision Closure Set

  • Bi-Fix Non-invasive Surgical Incision Closure Set
  • Bi-Fix Non-invasive Surgical Incision Closure Set
  • Bi-Fix Non-invasive Surgical Incision Closure Set
  • Bi-Fix Non-invasive Surgical Incision Closure Set
  • Bi-Fix Non-invasive Surgical Incision Closure Set
  • Bi-Fix™
  • China

How to close wounds without stitches and reduce surgical scars has become one of the most concerned problems of patients today.

Bifix™ surgical incision closure set is a disposable device that intends to close the surgical incision or wound without stitches, reduce the tension of skin and let it heal naturally. It improves the appearance of scars eventually. This is a non-invasive and advanced choice of wound closing comparing to the traditional methods like suture and skin stapler.

Bi-FixTM Non-invasive Surgical Incision Closure Set without Stitches



Bi-fix surgical incision closure set is formed by two closure strips and a unique closing system. The operation is very simple: stick the two strips to both sides of incision and screw the locking system with the spiral levers to shorten the distance of incision evenly until fully closed. It will constantly provide a proper force to reduce the tension of incision in 14 days during the natural healing time of ourselves and avoid the secondary damage to the skin. 


After 5 years of clinical practice and over quarter million cases,  Bi-fix has become one of the most popular skin closing options for cuticle closure of surgical wounds on the skin surface. We have collected many pictures by using Bifix that indicated a better scar appearance comparing to the regular stitching treatment. The unique spiral fastening structure allows a simple, convenient and reliable operation, to meet the needs of wound closure to a greater extent; the force on both sides of the incision can be adjusted precisely, which is particularly important in the cases of wound edema and subsided inflammatory reaction. It can effectively reduce the generation of hypertrophic scar tissues, to truly achieve a better appearance.  At present, the product has various sizes for general surgery, obstetrics, orthopedics, minimally invasive surgery. (Learn more from the clinical video)


Bi-fix surgical incision closure set can overcome the disadvantage of suture, staple and glue shown as below.



Compared with Suture, Staple and Glue in Surgical Skin Closure


Disadvantages of Suture, Staple and Glue

  1. Higher requirements for doctor suturing skill, foreign body reaction, and longer operation time.

  2. Puncture the skin, enormous secondary damage to the skin, easy to be infected, need to be removed, and can easily produce centipede-like scars.

  3. High biocompatibility requirements, difficult for postoperative care, only can be used in incisions with less tension and high requirements for subcutaneous sutures.



Bi-Fix Non-invasive Surgical Incision Closure Set

Risk of scar and infection when using suture, staple and tissue adhesive




Bi-Fix Non-invasive Surgical Incision Closure Set
Adjustable Wound Closure, Good Blood Perfusion, Good Wound Healing

Bi-Fix Non-invasive Surgical Incision Closure Set

High Wound Closing Tension, Insufficient Blood Perfusion, 

Easy to Cause Wound Complications

No Needles, No Foreign Body Stimulation, Aesthetic Wound Healing
Bi-Fix Non-invasive Surgical Incision Closure Set Secondary Damage, Foreign Body Stimulation, Easy to Cause Tissue Fibrosis and Scars
Simple and Fast Operation, Operating Time Saving
Bi-Fix Non-invasive Surgical Incision Closure Set Long Suturing Time, Complicated Operating Process
No Need for Return and Stapler Removal, Can be Removed by PatientsBi-Fix Non-invasive Surgical Incision Closure Set Need to Remove the Suture or Staples, Increase the Burden of Patients




The Benefits of Bi-FixTM Surgical Incision Closure Set


FOR PATIENTS


  • No Secondary Damage from Bi-fixTM:

  1. No piercing of healthy skin and no foreign material left

  2. Less pain and less stress( especially for kids and elders)

  3. Fewer risks (infection, complications, anaesthetic)

  4. Less downtime (sick leave, off work time)—no need to go back for a removal


  • Minimize Scar

    Bi-fix aligns skin edges in the same planar level precisely, providing a better result for minimizing scars.


  • Inhibit Infection

    Added hydrocolloid in the tape allows Bi-fix to absorb the excess moisture, blood and exudate to create a dry and clean healing environment in which bacteria has lower survival chance. This also strengthens the adhesiveness of the tape to last over 14 days.


  • Comfortable to wear

    The breathable, waterproof TPU film of the tape and the locking mechanism & regulating lever consisting of implantable nylon offer a biocompatible and comfortable wearing experience.


  • Hypoallergenic 

    The pressure sensitive adhesive tape barely causes allergy to the skin.


  • Greater Range of Motion

    Bi-fix offers convenience because the closures can be exposed immediately to routine daily activities with minimal restrictions. And the flexibility of the materials provides great range of motion especially for joint parts.



FOR SURGEONS

  • Reduces Cost

    Reduce OR time and improves efficiency

    Reduces incision-related events: phone calls, ER admissions and antibiotics prescribed

    Eliminates clinic or nurse visit for a removal


  • Easy and Quick To Learn & Apply

    The adhesive & screw design of Bi-fix help to bring both sides of the wound together fast, very easy to learn and apply.

    Bi-fix quickly assesses the size configuration that will best accommodate the anatomical structure and area.


  • Precise Control & Flexibility

    Successively align skin edges precisely with the screwing design of Bi-fix, easy to achieve great results.

    The topical, noninvasive design of Bi-fix allows it to easily and quickly modify or remove during or after closing an incision.


  • Improves Closure Strength and Protection

    Patented screwing design provides

    Cross-incisional strength that locks in the skin edges with a uniform& precise distribution of tension and excellent long-term adhesion.

    Greater isolation from tension that promotes keloid & hypertrophic scars

    Higher tissue perfusion to promote healing and reduce complications


  • Excellent Cosmetic Results

  1. Bi-fix's non-invasive coaptive film and unique approach of aligning, approximating and closing the skin edges on a planar and flat level

    enable the surgeon to avoid unwanted "track marks", waviness, bunching and buckling which can occur using suture or stapler.

    drive patient endorsements and overall satisfaction.

  2. Visible and Simple in Wound Care Management

    The clear coaptive film of Bi-fix provides immediate visibility to the wound for fast, easy assessment and care. 

    Bi-fix does not block wound drainage or seal in potential infections either.

  3. Primary Intention Achieved

    Bi-fix directly apposes the tissue layers, which serves to minimize new tissue formation within the wound and facilitates the biological event of healing.

  4. Versatile Closure

    Bi-fix is applicable from small laparoscopic incisions to long knee joint replacement, to curved areas such as in breast reconstruction.

  5. Safer Environment 

    Increases staff safety with fewer needle-stick injuries and related potential disease transmissions.




Patented Screw Regulating Design


Bi-Fix Non-invasive Surgical Incision Closure Set



Bi-Fix Non-invasive Surgical Incision Closure Set



Why Screw Design?

The screw closing method is easy to operate to achieve precise closure and provide proper force to counteract skin tension during the healing of incision. Compared with other similar products, accuracy of Bi-Fix can be controlled up to 1 mm. When regulated too tight, this system allows surgeons to unlock and rotate the lever counterclockwise to adjust the closing strength.





How's the Performance of Bi-FixTM Incision Closure Set in Surgery?


We had processed contrast experiments in lab, proving that Bi-Fix can replace suture or other wound closing methods in most of regular surgical closure cases. The Bi-Fix Surgical Incision Closure Set can provide full strength to close a surgical incision with a better result. The following data is gotten from 144 surgery cases.



Bi-Fix Non-invasive Surgical Incision Closure Set

In experimental group, the time of closing incision is 3.40±1.94min with Bi-Fix applied, while 5.53±1.93min with suture in control group. It was quicker with Bi-Fix than traditional suture closing method.





The pain degree is evaluated by patients when the removal of Bi-Fix and suture 5th~7th day post-op, more bigger more pain. In experimental group, removal of Bi-Fix is evaluated as 0.58±0.68 while 2.09±0.84 with suture in control group. Patients feel more comfortable with Bi-Fix than suture in removal.





Around 14th day post-op, doctors evaluated patients' wound aesthetics of experimental group and control group both. Doctors considered that 98.6% of healing wounds were nice-looking in experimental group, while 34.7% in control group. Healing incisions look better with Bi-Fix applied than suture.




In lab, we also processed a test of tension strength to see if Bi-Fix could replace suture indeed. The result is that Bi-Fix go through a strength test of up to 16N, while #1 suture is only 6.47N~9.11N. Bi-Fix can replace suture in incision closing indeed in operation room.




Product Components & Material



Bi-Fix Non-invasive Surgical Incision Closure Set



  • Anti-rotating back lock: Prevents the adjusting lever from rotating back due to strong skin tension.

  • Adjusting lever releasing handle: Suitable for joints to bend and stretch.

  • The PSA tape is consist of three layers: Breathable TPU film layer, hydrocolloid pad layer, and medical pressure sensitive adhesive layer.



Applications in Clinical Case


1. General Surgery


Learn More
Bi-Fix Non-invasive Surgical Incision Closure Set Bi-Fix Non-invasive Surgical Incision Closure Set Bi-Fix Non-invasive Surgical Incision Closure Set
Application in Abdominal Surgery
Post Operative Incision Appearance

2. Orthopedics Surgery


Learn More
Bi-Fix Non-invasive Surgical Incision Closure Set Bi-Fix Non-invasive Surgical Incision Closure Set Bi-Fix Non-invasive Surgical Incision Closure Set
Application in Humerus Fracture Fixation Surgery
Post Operative Incision Appearance

3. Obstetric Surgery


Learn More
Bi-Fix Non-invasive Surgical Incision Closure Set Bi-Fix Non-invasive Surgical Incision Closure Set Bi-Fix Non-invasive Surgical Incision Closure Set
Application on Transverse Incision
Post Operative Incision Appearance



Bi-Fix Non-invasive Surgical Incision Closure Set Bi-Fix Non-invasive Surgical Incision Closure Set Bi-Fix Non-invasive Surgical Incision Closure Set
Application on Longitudinal Incision
Post Operative Incision Appearance








Typical Clinical Operation Video









Specifications



Bi-Fix Non-invasive Surgical Incision Closure Set



Manufacturer Information



[ Manufacturer ] Zhejiang Haichuang Medical Device Co., Ltd


Haichuang Medical is a medical supplier from Hangzhou, China, aiming to promote and sell Bi-Fix Wound Closure Set product to global market. Looking forward to receiving inquiries for quotation from who would like to be our agent or distributor. 


[ Product Name ] Surgical Incision Closure Set

[ Packing specifications ] 120 Sets / Box

[ Valid Period ] 30 months

[ Applicable Departments ] General surgery, orthopedics, obstetrics, plastic surgery, thoracic surgery, minimally invasive surgery and pediatric surgery

[ Storage Requirements ]  5-30°C, keep in a sealed, cool and dry environment and avoid direct sunlight

[ Address ] 146 Chaofeng RD, Yuhang economic development zone, Hangzhou, Zhejiang, China



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