Glycerol Preserved Skin

GPS™ Glycerol-Preserved Skin for Biological Wound Dressing

Glycerol preserved Skin Glycerol Preserved Skin

Wide and extensive clinical experience with GPSU1 for the treatment of burns shows that GPS™ is effective as a biological wound dressing with little risks of disease transmission. GPS™ costs relatively low compared with cryopreserved skin allografts or synthetic skin substitutes and ease of handling confers practical advantages in transport and distribution. Thus, GPSU1 has been used as a general biological wound dressing for more than a decade in EU.

GPS™ is stored in a domestic refrigerator and does not deteriorate appreciably at room temperature since no specific treatment is included for the processing.

Indication

  • Treatment of skin defects due to burns or chronic diseases
  • Prevention of infection in skin defects
  • Temporary wound covering before split skin autografting
  • Dressing after skin autografting

Compare with Another Product and Autograft
Manufacturer (Country) Hans Biomed Corp (USA) Tissue Bank (USA) Patient's Own Skin
Product Name Glycerol Preserve Skin Cryopreserved skin allograft Patient's own skin
Characteristics and Use
  1. Donor skin is harvested and preserved in 85%glycerol solution
  2. . Store aI4°C. Prior use, rinse with physiological saline solution for 4-10 minutes to wash out the glycerol.
  1. Donor skin is preserved in cell culture medium.
  2. Cryoprotectant is added and the donor skin is frozen down to -4O"C with regular chilling gradient.
  3. Store in a deep-freezer (under -lO°C). Before use, thaw the cryopreserved skin at 37"C and rinse with physiological saline solution
    for 5 minutes.

 

 Patient's own skin is harvested and used immediately.
Advantages
  1. Secondary wounds are
    not generated when
    compared with skin
    autografting.
  2. Tissues do not
    deteriorate remarkably when compared with cryopreserved skin.
  3. Preservation procedure is simple and relatively inexpensive.
  4. GPS'w is kept in a
    domestic refrigerator
    which confers ease of
    storage and transport.
  5. Procedures for clinical
    use are simple and
    uncomplicated.
  1. Secondary wounds are not generated when compared with skin autografting.
  2. It is kept in a (deep-)freezer and used on the occasion of clinical use.
 Additional costs are not required for the use of skin.
Disadvantages  
  1. Costs are high when
    compared with skin autografts
  2. It should be kept in a deep-freezer (below -JOC) which requires specific control for storage and consequently high cost.
  3. Deterioration of skin tissue and increase of cost are concerned due to careful handing at extremely low temperature.
  4. During the process of cryopreservation, ice crystals may deteriorate the skin tissue which consequently decreases the ability of skin restoration.
  1. For larger scald burns, the autologous skin may not cover the wound.
  2. Secondary wounds are inevitably generated for the skin harvest, which are followed by burden of extra-costs for wound restoring and hospitalization.
  3. Infection may occur in the process of skin harvest.

Clinical use of GPS™

GPS™ should be stored at 2-8°C in a refrigerator immediately of supply. A label is attached to every container, stating the product serial number and the area of the donor skin. Product serial number is used to get further information of the product, e.g., donor selection procedure, results of hematological microbiological laboratory tests, and processing for preservation. It provides a reliable method of checking back the product at any time and thus ensures the safety of the product.

Rinsing out the glycerol

GPS™ is free from bacteria and rules for keeping it sterile must be applied when using it. Before it can be used on patients, the required amount of donor skin must be removed from the containers and rinsed for -1-10 minutes in a large "volume of sterile, physiological saline solution. To be more effective, repeated rinsing procedures with fresh, sterile, physiological saLine solution for .5 minutes X2 are recommendable. Because of the viscosity of glycerol it is advisable to use a lukewarm solution for this. If the whole contents of the container are not used, the required amount can be cut off with sterile scissors and the remainder stored in the resealed container.

Method of use for clinical use

2nd degree burns by hot water/scalds

As a result of the capillary stasis in the wound bed during the first 48 hours, there is a chance of the wound bed drying Out and the burn becoming deeper. This is prevented by immediate application of donor skin, where immediate is defined as within 6 hours of the burn occurring. Preferably', no ointment should be put on the wound. If ointment has been used as first aid, clean the wound thoroughly first. A significant reduction in pain is experienced very soon after the application. In the first instance the donor skin is adherentl and remains in place like a supple scab. In general a very rapid, high-grade epithelialization takes place under it, after which the dried-out scab comes loose.

A. Method of use

After the wound bed is cleaned, the wound is covered with GPS™ just contacting the dermal layer. Special attentions should be paid not to make gaps between pieces of GPS™; the pieces are placed as closely as possible and, if necessary, mar be overlapped. GpsT:Il is fixed with staples to prevent possible drift of material. Small doses of anesthetics (e.g., administration of ketamine at the edge of GPS™ may be necessary. For the application at the chest, adhesive bandage (e.g., Polyfix) is useful. Dressing is carried out by use of dry gauzes, bandage and Banadafix. The wound should be inspected every day. The bandage just out around the fixed pan should be removed for the inspection. When necessary, drugs may be administered.

B. Use of GPS™no as a diagnostic

Skin allograft may be used as a diagnostic measure to determine the status of wound: when GPS™comes loose and does not fix to the wound, potential infection or deterioration of skin defects is predictable. For the diagnostic use of GPS™, it should be applied to the wound.

3rd degree burns

After operative removal of the necrotic tissue, the wound is covered with an autograft. When (because of shortage of the patient's own skin) this graft is meshed in the ration 1:4 or greater, or when there are wide-spread skin islands (Meek-Wall), this graft can be covered with skin allografts (so-called sandwich grafting). Donor skin in sandwich graft promotes rapid epithelialization and good drainage as well. GPS™ meshed in the ration 1:1.5 is recommendable for this technique. (Recently good clinical results were obtained with the ration 1:3.) Application of GPS™' may result in a mild antigenicity so that part of the donor skin may form a supple scab. This scab remains adhered to the wound bed to provide lasting wound coverage. A cleavage surface also forms in this scab, which the underlying autograft network uses to help it grow out. The result is a total wound closure after 4 to 5 weeks.

A. Method of use

After the wound bed has been cleaned, the wound is covered with an autograft. Then, GPS™ is applied without gap and bind the whole with wet/dry gauzes and bandage. For the first five days, wound inspection should take place down to the level of the fixation material, autograft and GPS™.

Clinical availability of GPS™

After washing out the glrcerol, GPS™ is same as conventional cryopreserved allografts in clinical use as a temporary biologic cover for wounds. GPS™ can be effectively used for scald burns. Grafts are easy to apply, provide immediate pain relief, and give excellent cosmetic results. (Schiozer WA et aI., Burns 1994; 20: 503-507). In addition GPS™ can be used as an overlay for wide meshed autologous skin in extensive full-thickness burns. GPS™ is effective as a temporary cover for excised wounds for which autologous skin is unavailable. GPS™ can also be used for chronic, poorly vascularised wounds to improve the condition of the wound bed before autografting.