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Prevena Spine for Use in Spine Surgery

Primary Purpose

Surgery, Incision, Surgical

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Prevena Plus 125 Therapy Unit

Spine surgery

About this trial

This is an interventional treatment trial for Surgery focused on measuring negative pressure wound therapy, incisional wound therapy, spine surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Northwestern Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group 1 (control)

Group 2 (Prevena)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Frequency of Surgical site infections

Determine if infection is present at surgical site or not.

Frequency of Wound dehiscence

Determine if wound reopening (dehiscence) is present at surgical site or not.

Frequency of Seroma

Determine if seromas (collection of fluid under the skin) are present at surgical site or not.

Secondary Outcome Measures

Frequency of skin necrosis

Measure the frequency of patients who experience skin necrosis in the incision area

Frequency of readmission

Measure the frequency of patients who are readmitted following surgery

Full Information

NCT ID

NCT05555355

First Posted

May 4, 2022

Last Updated

February 7, 2023

Sponsor

Northwestern University

Collaborators

1. Study Identification

Unique Protocol Identification Number

NCT05555355

Brief Title

Prevena Spine for Use in Spine Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

June 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

4. Oversight

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

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgery, Incision, Surgical

Keywords

negative pressure wound therapy, incisional wound therapy, spine surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Single center study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

285 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (control)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Group 2 (Prevena)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Prevena Plus 125 Therapy Unit

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Spine surgery

Intervention Description

Patients will receive spine surgery

Primary Outcome Measure Information:

Title

Frequency of Surgical site infections

Description

Determine if infection is present at surgical site or not.

Time Frame

1-6 weeks following surgery

Title

Frequency of Wound dehiscence

Description

Determine if wound reopening (dehiscence) is present at surgical site or not.

Time Frame

1-6 weeks following surgery

Title

Frequency of Seroma

Description

Determine if seromas (collection of fluid under the skin) are present at surgical site or not.

Time Frame

1-6 weeks following surgery

Secondary Outcome Measure Information:

Title

Frequency of skin necrosis

Description

Measure the frequency of patients who experience skin necrosis in the incision area

Time Frame

1-6 weeks following surgery

Title

Frequency of readmission

Description

Measure the frequency of patients who are readmitted following surgery

Time Frame

1-6 weeks following surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Galiano, MD

Phone

312-695-6022

robert.galiano@nm.org

First Name & Middle Initial & Last Name or Official Title & Degree

Tokoya Williams, MD

Phone

3126955667

tokoya.williams@northwestern.edu

Facility Information:

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Galiano, MD

Phone

312-695-6022

robert.galiano@nm.org

First Name & Middle Initial & Last Name & Degree

Kristin Huffman, BS

Phone

3129267037

kristin.huffman@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Robert Galiano, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Prevena Spine for Use in Spine Surgery

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