sinaderm™

Sinaderm™

Description

Sinaderm™ is cryopreserved human fibroblast derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bio absorbable scaffold. Due to the containing of different biological factors, Sinaderm™ has a Reconstructive role as a biological dressing. The Sinaderm™ has been shown to provide four elements to the chronic wound repair process:

  1. Supply of different bioactive extracellular matrix components such as collagen, Fibronectin, Laminin, Proteoglycan and glycosaminoglycan.
  2. Function as a permissive, performed, normal human matrix for keratinocyte and fibroblast migration and proliferation.
  3. Release cytokines capable of reducing chronic wound inflammation.
  4. Provides fibroblast-derived cytokines, particularly angiogenic growth factors.

Indications and Clinical use

Sinaderm™ has been demonstrated in clinical trials to improve the healing of different wounds such as:

  • Dressing and cover the burn wounds
  • Diabetic ulcers
  • Chronic wounds
  • Urology surgeries
  • ENT (Ears, Nose, Throat) surgeries

Sinaderm™ is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than 6 weeks duration. Sinaderm™ should be used in conjunction with standard wound care regimens and in patients who have adequate blood supply to the involved wound.

Contraindications

The presence of active infection or the ulcer extended to the tendon, muscle, joint capsule, or bone exposure.

Precautions

  • Do not reuses, refreeze, or sterilize the product.
  • Do not use the product if there is evidence of container damage.

  • If the date and time stamped on the shipping box have expired.

The product must remain frozen (at -75̊ C ± 5̊ C or -20̊ C) continuously until ready for use.

Adverse events

To date, no immunologic reactions to Sinaderm™ have been reported.

Dosage and administration

For the treatment wounds, the recommended treatment regimen is one piece of Sinaderm™ implanted every 5 days, until the ulcer is healed.

Directions for use

The ulcer must be surgically (sharply) debrided: removing any necrotic or hyperkeratinized tissue, leaving a wound bed that meets the clinical criteria for skin grafting prior to application of Sinaderm™. If extensive bleeding is observed, the bleeding must be stopped before applying Sinaderm™.

Sinaderm™ should not be used if infection is present in the wound. Clinical treatment should be initiated to resolve the infection. Once infection has cleared, treatment with Sinaderm™ can be initiated or resumed.

Materials required for preparation and application:

  • Sterilized scissors
  • Sterilized forceps
  • Surgical gloves
  • Sterile normal saline (0.9% sodium chloride) at room temperature
  • Sterilized bathtub with lid
  • Clock or timer
  • Permanent ink marker
  • Thermometer
  • Rinsing stand for Sinaderm
  • Dressing supplies

Sinaderm™ is packaged in 2 pockets which were packed in a box that contains materials required for application and brochure. The inner pocket is sterile.

Preparation for use:

  1. Open the box and discharge the accessories and the foil pouch. Fill the water bath with 2 liters of water at 34˚C to 37 ˚C. Water temperature must not exceed 37 ˚C.
  2. Open the foil pouch and then take out the clear bag (which is included Sinaderm™) in sterile condition and immediately put the clear bag in the water bath.
  3. Place the thawing tub lid on the tub during the thawing process to keep the Sinaderm™ submerged. Allow approximately two minutes for thawing. The process is complete when there are no visible ice crystals within the clear bag.

  1. 4. Handling by the clear bag’s outer margins, place the bag into the rinsing stand without touching the areas of the bag that come in contact with Sinaderm™.

  1. Secure the clear bag inside the rinsing stand by using the locking clip at the bottom of the stand. Leave the bag in this locked position throughout the rinsing procedure. Immediately begin the rinsing process.

  1. Put on the sterile gloves and tear the clear bag with sterile scissors.

  1. Gently squeeze the clear bag and pour out the liquid. Fill the clear bag with room temperature sterile normal saline and wait for 5 seconds, then pour out the normal saline.

  1. Again fill the clear bag with room temperature sterile normal saline and wait for 5 seconds and then pour out the normal saline.

  1. For the third time again repeat step 8.

  1. For the last time again fill the clear bag with normal saline and hold. If you are ready to apply the product immediately hold the product in the saline at least 5 seconds, but if you are not ready to apply the product you can hold the product in saline up to 30 minutes.

  1. When you are ready to apply the Sinaderm™ on the wound completely drain the clear bag and then release the holding clip and remove the clear bag from the rinsing stand.

  1. Holding the clear bag in front of the wound and use a permanent marker to trace the edge of the wound onto the bag.

.

  1. Cut the clear bag along the traced lines and creating a handling tab to facilitate the implantation of Sinaderm™.

  1. Peel the plastic from both sides of the product using sterilized forceps.

NOTE: During the thawing and rinsing steps, do not touch the areas of the bag that come in contact with Sinaderm™.

 

  1. Implant the Sinaderm™ on to the debrided wound. Cover the surface of the whole wound by Sinaderm™ and pushes it gently on the wound to paste that on the wound and make sure no air is trapped between Sinaderm™ and wound bed, then with sterilized scissors, trim the excess handling tab.

  1. Cover the wound using of dressing supplies which was inside the box of the product.

Important notes

  1. Between routine applications of Sinaderm™, it is important to maintain a moist wound environment.
  2. Following each application of Sinaderm™, the first wound dressing change should take place in approximately 72 hours.

  1. After washing the Sinaderm™ use it immediately to prevent drying.
  2. Remove the pocket label and put it on the patient chart. This label is included of Lot Number and expiration date.
  3. Following each application of Sinaderm™, the first signs of wound improvement will be observed in approximately first 5 days.
  4. Dispose of all liquid, rinsing solutions, and Sinaderm™ components in accordance with institution or government environmental regulations.

Storage recommendations

Sinaderm™ can be stored frozen for up to 6 months at -75̊ C ± 5 ̊C and up to 3 months at -20 ̊C. The insulated shipping container should contain dry ice (solid carbon dioxide) for distances which is more than 3 hours needed and for less than 3 hours distances, normal ice packs can be used.