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.

Study Overview

• Status: Unknown
• Conditions: Complications Wounds
• Intervention / Treatment: Device: Combined TopClosure & Vcare Alpha

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sigal Ezra, RN, MA; Phone Number: 97235303703; Email: sigal.ezra@sheba.health.gov.il
• Study Contact Backup: Name: Sigal Ezra, MA; Phone Number: +97235303703; Email: sigal.ezra@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Sheba Medical Center, Medical Center

Publications and helpful links

General Publications

• 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
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2017
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): August 30, 2019

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: March 4, 2017
• First Posted (ACTUAL): March 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 6, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: SHEBA-3907-17-SMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No