Prevena Spine for Use in Spine Surgery

Surgery Clinical Trial

Official title:

A Prospective, Single-center Study for the Investigation of the Use of Prevena Vacuum-Assisted Closure Devices in Patients Undergoing Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555355
• Other study ID #: STU00216293
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: Northwestern University
• Contact: Robert Galiano, MD
• Phone: 312-695-6022
• Email: robert.galiano[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pilot, prospective, single-center study for the investigation of the use of Prevena Vacuum-Assisted Closure devices in patients undergoing spine surgery.

Description:

The objective of the study is to evaluate the efficacy of the Prevena Plus 125 therapy Unit (KCI USA, Inc.) in preventing surgical site infections and other wound complications in patients undergoing spine surgery compared to conventional wound dressing. Furthermore, the investigators want to illustrate which patients benefit most significantly from Prevena usage as spine surgery sees a range of potential candidates, and not all may experience equivalent recovery from spine surgery with Prevena intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 285
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients undergoing spine surgery that requires closure by plastic surgeon

2. Over 18 years old

3. Risk Score Cutoff 80+

4. (Control) Matched to a prospective research participant

Exclusion Criteria:

1. Risk Score Cutoff <80

2. Medical or psychiatric condition that may increase the risk with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the subject inappropriate for entry into this study

3. Subjects who are pregnant at the date of surgery (SOC for surgery)

Related Conditions & MeSH terms

• Incision, Surgical
• Surgery
• Surgical Wound

Intervention

Device:
• Prevena Plus 125 Therapy Unit
The investigators will utilize the KCI USA, Inc Prevena Plus 125 vacuum-assisted closure device in patients undergoing spine surgery as a method to prevent surgical site infections and wound dehiscence after surgery. The device has been approved by the FDA under the name "Prevena 125 and Prevena Plus 125 Therapy Units" and regulation number 21CFR 878.4783.

Procedure:
• Spine surgery
Patients will receive spine surgery

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Surgical site infections	Determine if infection is present at surgical site or not.	1-6 weeks following surgery
Primary	Frequency of Wound dehiscence	Determine if wound reopening (dehiscence) is present at surgical site or not.	1-6 weeks following surgery
Primary	Frequency of Seroma	Determine if seromas (collection of fluid under the skin) are present at surgical site or not.	1-6 weeks following surgery
Secondary	Frequency of skin necrosis	Measure the frequency of patients who experience skin necrosis in the incision area	1-6 weeks following surgery
Secondary	Frequency of readmission	Measure the frequency of patients who are readmitted following surgery	1-6 weeks following surgery