Treatment (NPWT with Instillation) for Pressure Ulcer

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Pressure UlcerV.A.C.Ulta™ Negative Pressure Wound Therapy System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions
  • Pressure Ulcer

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 1 year post-closure surgery

1 year post-closure surgery
Proteome
Injury wounds
Week 6
Pressure Ulcer
Month 5
Bioburden assessment
Cost Analysis
Debridement
up to 3 months
Total Length of Stay

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Control (Wet-to-dry dressings)
1 of 2
Treatment (NPWT with Instillation)
1 of 2

Active Control

Experimental Treatment

62 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment (NPWT with Instillation) · No Placebo Group · Phase 4

Treatment (NPWT with Instillation)
Device
Experimental Group · 1 Intervention: V.A.C.Ulta™ Negative Pressure Wound Therapy System · Intervention Types: Device
Control (Wet-to-dry dressings)
Other
ActiveComparator Group · 1 Intervention: Standard of Care (Wet-to-dry dressings) · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post-closure surgery

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,448 Previous Clinical Trials
775,837 Total Patients Enrolled
1 Trials studying Pressure Ulcer
200 Patients Enrolled for Pressure Ulcer
3MIndustry Sponsor
145 Previous Clinical Trials
31,218 Total Patients Enrolled
2 Trials studying Pressure Ulcer
385 Patients Enrolled for Pressure Ulcer
Robert Galiano, MDPrincipal InvestigatorNorthwestern University
4 Previous Clinical Trials
378 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Any pressure sore that has the potential for a good seal.