Prevena Spine for Use in Spine Surgery

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05555355

Collaborator

3M (Industry)

285

Enrollment

Location

Arms

Anticipated Duration (Months)

28.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgery Incision, Surgical	Device: Prevena Plus 125 Therapy Unit Procedure: Spine surgery	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

285 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single center studySingle center study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group 1 (control) Retrospective control of patients who did not use Prevena following spine surgery.	Procedure: Spine surgery Patients will receive spine surgery
Active Comparator: Group 2 (Prevena) Prospective group of patients receiving spine surgery who will have Prevena applied to incision area.	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

Arm

Intervention/Treatment

Placebo Comparator: Group 1 (control)

Retrospective control of patients who did not use Prevena following spine surgery.

Procedure: Spine surgery

Patients will receive spine surgery

Active Comparator: Group 2 (Prevena)

Prospective group of patients receiving spine surgery who will have Prevena applied to incision area.

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

Outcome Measures

Primary Outcome Measures

Frequency of Surgical site infections [1-6 weeks following surgery]
Determine if infection is present at surgical site or not.
Frequency of Wound dehiscence [1-6 weeks following surgery]
Determine if wound reopening (dehiscence) is present at surgical site or not.
Frequency of Seroma [1-6 weeks following surgery]
Determine if seromas (collection of fluid under the skin) are present at surgical site or not.

Secondary Outcome Measures

Frequency of skin necrosis [1-6 weeks following surgery]
Measure the frequency of patients who experience skin necrosis in the incision area
Frequency of readmission [1-6 weeks following surgery]
Measure the frequency of patients who are readmitted following surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients undergoing spine surgery that requires closure by plastic surgeon
Over 18 years old
Risk Score Cutoff 80+
(Control) Matched to a prospective research participant

Exclusion Criteria:

Risk Score Cutoff <80
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
Subjects who are pregnant at the date of surgery (SOC for surgery)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University
3M

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Galiano, Associate Professor of Surgery, Northwestern University

ClinicalTrials.gov Identifier:

NCT05555355

Other Study ID Numbers:

STU00216293

First Posted:

Sep 26, 2022

Last Update Posted:

Nov 9, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Robert Galiano, Associate Professor of Surgery, Northwestern University

negative pressure wound therapy

incisional wound therapy

spine surgery

Additional relevant MeSH terms:

Surgical Wound

Study Results

No Results Posted as of Nov 9, 2022