Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings

Northwell Health

Status: Withdrawn

Conditions: Venous Leg Ulcer

Treatments: Procedure: Compression Dressing; Device: PICO Negative Pressure Wound Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03450616

17-0951

Details and patient eligibility

About

This study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy compares to standard care treatment for venous stasis ulcers, as there is no evidence to date.

Full description

This is a single-blind, randomized pilot study conducted in patients with bilateral venous stasis leg ulcers.

The aim of the study is to compare the rate of healing for venous stasis ulcers when using the PICO™ single use Negative pressure wound therapy (NPWT) system versus standard care.

The primary objective is to determine if the PICO™ NPWT system results in an increased rate of healing when compared to standard of care for the treatment of venous stasis ulcers.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with bilateral venous leg ulcers (one on each lower extremity) (defined as any break in the skin that has either been present for longer than 6 wks or occurred in a person with a history of venous leg ulceration).
• The ulcer is required to be venous in appearance (ie: moist, shallow, and of an irregular shape), and judged unlikely to heal within 21 days.
• 18 years old or older
• Have an ankle brachial pressure index of at least 0.8 that was measured within the previous 3 months.

Exclusion criteria

• • Patients on anticoagulants- (ie: warfarin, direct thrombin inhibitors).

  • Patients who have a pressure index measured within the previous 3 months to be greater than 1.20
  • Patients with venous stasis ulcers greater than 17cm by 17cm.
  • Gross leg edema
  • Severe wound exudate
  • Patients with malignancy in the wound bed or margins of the wound
  • Previously confirmed and untreated osteomyelitis.
  • Patients with necrotic tissue with eschar present.
  • Patients with wounds that involve exposed arteries, veins, nerves, bone fragments or sharp edges.
  • Patients with wounds that requires surgical suction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Negative Pressure Wound Therapy

Experimental group

Description:

Subjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device

Treatment:

Device: PICO Negative Pressure Wound Therapy

Compression Dressing- Standard of Care

Active Comparator group

Description:

Subjects will have one venous stasis ulcer treated with the standard of care compression dressing.

Treatment:

Procedure: Compression Dressing