An interventional study of Combined TopClosure & Vcare Alpha in Complications Wounds, sponsored by Sheba Medical Center. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 50 is close to the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
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1.A patient in our in-patient rehabilitation ward that is willing to participate in our study and is willing to be constrained to his bed for the time of the study.
Exclusion Criteria:
The investigators will debride the wound if necessary. Wound biopsies will be taken to determine the existing pathogens and direct the antibiotic treatment. Wound measurements will be taken. Afterwards the wound will be approximated by the TopClosure device and the patient will be connected to a Negative Wound pressure device Vcare Alpha. 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, 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-NPT) up to 10 weeks.
Device: Combined TopClosure & Vcare Alpha
Combined TopClosure \& Vcare Alpha Treatment. The investigators will debride the wound if necessary. Wound biopsies will be taken to determine the existing pathogens and direct the antibiotic treatment. Wound measurements will be taken. Afterwards the wound will be approximated by the TopClosure device and the patient will be connected to a Negative Wound pressure device Vcare Alpha. 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, 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-NPT) up to 10 weeks.
Time to wound healing
the wound will be closed with the TopClosure device and the patient will be connected to a Negative Wound pressure device Vcare Alpha.
Time frame: determine the time to heal from connecting the patient to the Vcare Alpha device until the wound is clean and there is no further need for Negative Pressure Wound Treatment up to 10 weeks
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center