Novel Methods for Management of Complicated Wounds

Not Applicable

• Conditions: Complications Wounds
• Interventions: Device: Combined TopClosure & Vcare Alpha

• Registration Number: NCT03074981
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-03-04
• Study First Posted: 2017-03-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-06
• Last Update Posted: 2017-05-09
• Study Start: 2017-06-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined TopClosure & Vcare Alpha Treatment	Combined TopClosure & Vcare Alpha	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.

Primary Outcome Measures

Name	Time	Method
Time to wound healing	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	the wound will be closed with the TopClosure device and the patient will be connected to a Negative Wound pressure device Vcare Alpha.