INSTRUCTIONS FOR USE AND CONTENTS
Glyaderm, (Glycerol preserved acellular dermis)
Plain or Mesh 1:1 (perforated)
COMPOSITION
Active ingredients: acellular human skin
The sheets of glyaderm measure 45 to 200 cm2.
The sheets of glyaderm can be supplied whole (plain) or meshed 1:1
The sheets of glyaderm are at least 4 cm wide.
The thickness of the different products is shown in table below:
Glyaderm
Thickness (mm)
Unmeshed
0.2-0.4
Meshed 1:1
0.2-0.4
Other ingredients: glycerol 85%
ORIGIN (SOURCE) AND PACKAGE UNIT
Graft of human origin, acellular donor dermis, in glycerol.
Individually packed in sealed sterile container.
PRODUCER
Stichting Euro Skin Bank - Huidbank, Beverwijk, The Netherlands.
Euro Skin Bank Foundation is operating according to an ISO
9001:2008, certified by KEMA Quality B.V. no. 2110349. The Euro Skin Bank has an
accreditation of the Ministry of Health, Welfare and Sports.
EURO SKIN BANK
Zeestraat 29
1941 AJ BEVERWIJK
The Netherlands
Telefoon: +31 251 27 88 88
Fax: +31 251 22 44 08
POSTAL ADDRESS
P.O. Box 1015
1940 EA BEVERWIJK
TRACEABILITY
To ensure identification of glyaderm, the code on the container must be kept in the patient files. The label
attached to the container can be used for this.
INDICATIONS FOR USE
The glyaderm, preserved in glycerol, is for single use, and used as a dermal substitute in the treatment of
full thickness skin defects to improve the quality of the final scar and to reduce wound contraction.
Glyaderm can be used as implant in excised burns, reconstructive surgical wounds, chronic wounds after
debridement.
CONTRA INDICATIONS
Use during pregnancy or during breast-feeding: no harmful effects
of using Glyaderm are known.
PRECAUTIONARY MEASURES DURING USE
Penicillin/streptomycin or gentamycin are used in the preservation
process of the glyaderm; there may be traces of these antibiotics in the
glycerol solution. So an allergic reaction cannot be totally excluded
in hyperallergic patients.
INTERACTION WITH OTHER MATERIALS
Not yet known
WARNING
Virologically contaminated skin is rejected during donor selection
and by serological testing. Criteria based on the guidelines of the
Council of Europe and the European Association of Tissue
Banking are used for donor selection. Glyaderm is prepared
using aseptic methods and checked for bacteriological
contamination. Yet, with the current level of knowledge, infection
cannot be excluded for 100%.
In case of adverse reaction of the patient possibly related to the glyaderm, this has to be reported
immediately to Euro Skin Bank.
QUANTITY, TYPE AND DURATION OF APPLICATION
The amount of glyaderm required depends on the height and
weight of the patient, their immunological characteristics, the
extent of the wounds or burns and the application method.
The area of wound to be covered and the amount of glyaderm
required for this is determined by the doctor. Glyaderm must be applied only on a wound bed with good
condition to allow ingrowth of recients blood vessels. For some wounds, pretreatment with allogeneic
donor skin or VAC therapy may be required
The glyaderm is used as an implant and is not removed; best results are obtained in a two stage
procedure. Coverage with autologous skin can be performed at 5-7 days after application of glyaderm;
determined by the doctor. During the interval between the first and second operation the Glyaderm must
be covered with a wound dressing preventing dessication and infection, for example Surfasoft and
Isobetadine gel.
RINSING OUT THE GLYCEROL
Preserved glyaderm is free from bacteria, and rules for keeping it
sterile must be applied when using it.
Before it can be used, the required amount of glyaderm must be
removed from the containers and rinsed for 4-10 minutes in a large
volume of sterile, physiological saline solution.
Because of the viscosity of glycerol it is advisable to use a lukewarm
solution for this. If the whole content of the container is not used, the required
amount can be cut off with sterile scissors and the remainder
stored in the resealed container.
SIDE EFFECTS
Not yet known.
RECOMMENDATION
This material, if unopened and stored at a temperature of 4-8ºC, can
be kept until the expiration date on the container.
If the container is opened, the donor skin can be kept for 48 hours
at 4-8ºC. Contamination cannot be excluded after this period.
After rinsing, the glyaderm can be kept at room temperature for 12
hours. Do not freeze the glyaderm.
The organisation were the glyaderm will be used on recipients is responsible to store the skin under the
appropriate conditions.
This material must not be used after the expiry date has passed.
Euro Skin Bank, September 2011