NPWTi on Closure of Chronic Pressure Sores

ConditionPressure Sore

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ischial and sacral wounds at stage 3 and 4.

Any pressure sore that has the potential for a good seal.

Disqualifiers

Any pressure sore that does not have potential for a good seal.

Patients with fecal incontinence (due to potential for pressure sore to be near the anus).

Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).

Patients who are pregnant. This is standard of care for surgery anyway, and there is uncertainty of how both the surgery and intervention would affect the fetus. We therefore stress any form of birth control, abstinence, and method to prevent pregnancy for those enrolled in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
Wet-to-dry dressings

Treatment groups

62 Participants

are divided into 2 treatment groups

Group A: Control (Wet-to-dry dressings)Active comparator 1 intervention

Group B: Treatment (NPWT with Instillation)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Total Length of Stay

Record the number of days spent in the hospital from initial debridement (first visit with plastic surgeon) to discharge from hospital following surgery

Time frame

up to 3 months

Secondary outcomes

Cost Analysis

Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care.

Time frame

Through study completion, approximately 5 months

Number of debridements

Record the total number of debridements performed at the wound site throughout the duration of the study

Time frame

Through study completion, approximately 5 months

Successful closure of pressure sores

Patients will be assessed for proper closure of the wound

Time frame

2 weeks and 6 weeks post-closure surgery

Other outcomes

Proteomic analysis

Amount of bacteria present in frozen tissue that was collected at treatment day 1 will be determined and compared between groups using a two sample t-test.

Time frame

1 year post-closure surgery

Bioburden assessment

Photos of the wound will be taken with a specialized bioburden camera, which can pick up on bacterial load of the wound. Photos will be taken before debridement, after debridement, after every dressing change, and on the day of surgery.

Time frame

Through study completion, approximately 5 months

Wound characteristic assessments

Wound characteristics collected by the 3D imaging as well as bioburden collected by the bioburden camera will be compared between the control and study groups. Each respective comparison will involve 2 independent sample t-tests.

Time frame

1 year post-closure surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Collaborator

Source ClinicalTrials.gov

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