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.
| Status | Not yet recruiting |
| Enrollment | 50 |
| Est. completion date | August 30, 2019 |
| Est. primary completion date | June 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: 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: 1. Patient with cognitive impairments interfering with his or her ability to understand the instructions by our team. 2. Patient that is not willing to be constrained to his bed for the time of the study. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center | Assaf-Harofeh Medical Center |
Topaz M, Carmel NN, Topaz G, Zilinsky I. A substitute for skin grafts, flaps, or internal tissue expanders in scalp defects following tumor ablative surgery. J Drugs Dermatol. 2014 Jan;13(1):48-55. — View Citation
Topaz, M., Bisker, O., Litmanovitch, M., & Keren, G. Application of regulated oxygen-enriched negative pressure-assisted wound therapy in combating anaerobic infections. European Journal of Plastic Surgery, 34(5), 351-358, 2011
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03010137 -
Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
|
N/A |