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Non-enteric/unexplored fistulas
Application of the wound dressing on non-enteric or unexplored fistulas is contraindicated, as it may damage the
intestinal structures and/or organs�
Untreated osteomyelitis
Application of the wound dressing in wounds with untreated osteomyelitis is contraindicated, as it may result in the
spreading of the infection�
Necrotic tissue
Application of the wound dressing on necrotic tissue is contraindicated, as it may lead to local spreading of the infection�
Application of VivanoMedFoam on nerves, anastomosis points, blood vessels or organs
VivanoMedFoam must not be applied directly over exposed nerves, anastomosis points, blood vessels or abdominal
organs as it may result in deterioration of the underlying structures�
1.3 Special precautions
Please pay attention to the following precautions:
Infected wounds
Wound dressings should be changed at regular intervals, according to the corresponding instructions for the materials
that you use� Infected wounds should be monitored more frequently, and may require wound dressings to be changed
more often�
NOTE: For more information on wound monitoring in the context of negative pressure wound therapy, please refer to the
Monitoring section of the corresponding instructions for the materials that you use�
Typical signs of wound infection are redness, swelling, itching, increased warmth of the wound itself or in the
neighbouring area, foul odour etc�
Infected wounds may trigger systemic infection, manifesting by high fever, headache, dizziness, nausea, vomiting,
diarrhea, disorientation, erythroderma etc� The consequences of systemic infection can be fatal�
IMPORTANT: If there is any suspicion of either local or systemic infection, contact the supervising physician and consult if
negative pressure wound therapy should be stopped, or an alternative therapy should be considered�
Blood vessels and organs
Blood vessels and organs should be adequately protected by means of fascias, tissues or other types of protective layers
placed above them�
IMPORTANT: Special precautions need to be taken, when dealing with infected, weakened, irradiated or sutured blood
vessels or body organs�
Bone fragments or sharp edges
Protruding bone fragments and sharp edges should be removed, or covered accordingly, before using VivanoMedFoam,
as they may damage blood vessels or body organs and cause bleeding�
NOTE: For more information related to bleeding in the context of negative pressure wound therapy, please refer to the
Bleeding section of this document�
Surgical incisions
Application of VivanoMedFoam on surgical incisions may be performed only with a suitable wound contact layer e�g�
AtraumanSilicone�
Enteric fistulas
In case of treatment of wounds containing explored enteric fistulas, additional level of precautions needs to be
implemented, if negative pressure wound therapy is to be applied� Presence of enteric fistula in close proximity to the
wound increases the risk of wound contamination and/or infection� In order to mitigate the risk associated with the
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