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Negative Pressure Wound Therapy
NPWTi for Pressure Sores
Phase 4
Recruiting
Led By Robert Galiano, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ischial and sacral wounds at stage 3 and 4
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-closure surgery
Awards & highlights
Study Summary
This trial will compare a new system to close pressure sores to traditional care, to see which is more effective.
Who is the study for?
This trial is for individuals with stage 3 or 4 pressure sores located on the ischial or sacral areas, which can be sealed effectively. It's not suitable for those without a good seal potential, pregnant women, patients with fecal incontinence, or anyone deemed unfit for surgery due to age, BMI, or other health issues.Check my eligibility
What is being tested?
The study tests if the V.A.C.Ulta™ Negative Pressure Wound Therapy System (NPWTi) is more effective at closing chronic pressure sores than standard wet-to-dry dressings after debridement (removal of damaged tissue).See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, skin irritation around the wound area from therapy system use and possible infection risks associated with any wound treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have deep wounds on my lower back or buttocks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-closure surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-closure surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total Length of Stay
Secondary outcome measures
Cost Analysis
Debridement
Pressure Ulcer
Other outcome measures
Bioburden assessment
Proteome
Injury wounds
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment (NPWT with Instillation)Experimental Treatment1 Intervention
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.
Group II: Control (Wet-to-dry dressings)Active Control1 Intervention
Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
916,919 Total Patients Enrolled
1 Trials studying Pressure Ulcer
80 Patients Enrolled for Pressure Ulcer
3MIndustry Sponsor
157 Previous Clinical Trials
31,412 Total Patients Enrolled
2 Trials studying Pressure Ulcer
385 Patients Enrolled for Pressure Ulcer
Robert Galiano, MDPrincipal InvestigatorNorthwestern University
4 Previous Clinical Trials
418 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have deep wounds on my lower back or buttocks.I have a pressure sore that can heal well.You have a pressure sore that cannot be properly covered or sealed.My doctor thinks surgery isn't safe for me due to my age, weight, or other health issues.I have issues controlling my bowel movements.
Research Study Groups:
This trial has the following groups:- Group 1: Control (Wet-to-dry dressings)
- Group 2: Treatment (NPWT with Instillation)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being chosen to participate in this clinical trial?
"Yes, the evidence on clinicaltrials.gov confirms that this trial is making efforts to recruit participants. It was first announced on September 26th 2022 and updated lastly in November 8th of the same year. 62 patients are being requested from a single medical center for enrollment."
Answered by AI
What potential risks are associated with Negative Pressure Wound Therapy combined with Instillation?
"The safety of Treatment (NPWT with Instillation) was duly assessed as a 3, considering that it is currently approved by the FDA and categorized as a Phase 4 trial."
Answered by AI
Is there still an opportunity to volunteer for this experiment?
"Affirmative, clinicaltrials.gov data suggests that this medical investigation is actively seeking participants. This trial was first posted on September 26th 2022 and has since been updated to its current state on November 8th 2022. 62 individuals need to be enrolled from a single site."
Answered by AI
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