Novel Methods for Management of Complicated Wounds

NCT ID: NCT03074981

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-08-30

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.

Conditions

Complications Wounds

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Combined TopClosure & Vcare Alpha

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheba Medical Center

Role: PRINCIPAL_INVESTIGATOR

medical center

Central Contacts

Sigal Ezra, RN, MA

Role: CONTACT

sigal.ezra@sheba.health.gov.il

97235303703 ext. 0

Sigal Ezra, MA

Role: CONTACT

sigal.ezra@sheba.health.gov.il

+97235303703 ext. 0

References

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

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 24385119 (View on PubMed)

Other Identifiers

SHEBA-3907-17-SMC

Identifier Type: -

Identifier Source: org_study_id