Complications Wounds Clinical Trial
Official title:
Novel Methods for Management of Complicated Wounds
Difficult to heal wounds are a common and complex medical problem, causing suffer to the
patients and challenging medical, social and economic burden on the health system. Based on
data from the western world, it is estimated that in Israel, at any given time, 30 to 60
thousand patients with difficult to heal wounds. Among diabetics patients, it is estimated
that 15% to 25% will develop a difficult to heal foot wounds during their live time.
The medical definition of a difficult to heal wounds is: a wound showing no signs of
recovery after 4-6 weeks of treatment. Most of these wounds are caused by anaerobic bacteria
inventions.
One of the methods for the treatment of difficult to heal wounds is - ROI-RNPT (Regulated
Oxygen -Enriched & Irrigation Negative Pressure -Assisted Wound Therapy).
This method creates in the wound a negative pressure in the presence of oxygen and
irrigation applied directly into the wound bed.
As part of the wound closure process the investigators will use the "external tissue
expansion". This method under clinical use is exercised by the - "Top Closure" "tension
relief system" (TRS).
In this study, the investigators intend to investigate whether ROI-NPT system combined with
TopClosure, is effective for the treatment of difficult to heal wounds, compared with
methods currently in use.
1. The investigators will debride the wound if necessary. Wound biopsies will be taken to
determine the existing pathogens and direct the antibiotic treatment.
2. Wound measurements will be taken (Width, length and depth).
3. Afterwards the wound will be closed with the TopClosure device and the patient will be
connected to a Negative Wound pressure device Vcare Alpha.
4. the investigators will change dressings according to schedule. If the wound is clean
the investigators will change dressings every 3-5 days. If the wound is infected the
investigators will change dressings every 2-4 days. If the investigators encounter a
severe infected wound with a lot of pus the investigators will change dressings every
1-3 days.
5. the investigators will determine the time to heal when the wound is clean and there is
no further need for Negative Pressure Wound Treatment (ROI-NPR) up to 10 weeks.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03010137 -
Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
|
N/A |