NPWTi on Closure of Chronic Pressure Sores

Conditions

• Pressure Sore

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• V.A.C.Ulta™ Negative Pressure Wound Therapy System — DEVICE
  The V.A.C.Ulta™ Negative Pressure Wound Therapy System is a 510(k) - cleared, Class II device (K100657) with the following indication for use: "the V.A.C.Ulta™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
• Standard of Care (Wet-to-dry dressings) — OTHER
  Wet-to-dry dressings

Study Details

The primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. In this post-market, on-label study, we hope to show that the NPWTi system more effectively closes pressure sores following debridement than traditional care.

Key Dates

Start date

Sep 26, 2022

Status verified

Feb 2026

Primary completion

Jan 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

62 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Control (Wet-to-dry dressings)
  Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore.
• Experimental: Treatment (NPWT with Instillation)
  Subjects who are randomized into the treatment arm (NPWT with Instillation) will receive the V.A.C. VeraFlo™ Cleanse Choice Dressing Systems for treatment of their pressure sore.

Primary Outcome Measure

Total Length of Stay [ Time Frame: up to 3 months ]

Central Contacts

• Robert Galiano, MD
  3129267037
  [email protected]
• Kristin Huffman, B.S.
  3129267037
  [email protected]

Locations (1)

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