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Vacuum-Assisted Closure Device

Group 2 (Prevena) for Surgery

Phase 4
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Over 18 years old
Patients undergoing spine surgery that requires closure by plastic surgeon
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-6 weeks following surgery
Awards & highlights

Study Summary

This trial looks at using a special device to help with healing after spine surgery.

Who is the study for?
This trial is for adults over 18 who are having spine surgery and need a plastic surgeon to close the wound. They must have a risk score of 80 or above, indicating they're at higher risk for complications. Pregnant individuals, those with low-risk scores, or with conditions that could affect study results or compliance can't participate.Check my eligibility
What is being tested?
The study is testing Prevena Vacuum-Assisted Closure devices on patients undergoing spine surgery. It's designed to see if this device helps in healing surgical wounds better than usual methods.See study design
What are the potential side effects?
While specific side effects aren't listed here, vacuum-assisted closure devices like Prevena may cause skin irritation, discomfort at the application site, or allergic reactions to adhesive materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.
Select...
I need a plastic surgeon to close my wound after spine surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-6 weeks following surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 weeks following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Seroma
Communicable Diseases
Frequency of Wound dehiscence
Secondary outcome measures
Frequency of readmission
Frequency of skin necrosis

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group 2 (Prevena)Active Control2 Interventions
Prospective group of patients receiving spine surgery who will have Prevena applied to incision area.
Group II: Group 1 (control)Placebo Group1 Intervention
Retrospective control of patients who did not use Prevena following spine surgery.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,579 Previous Clinical Trials
916,500 Total Patients Enrolled
16 Trials studying Surgery
787 Patients Enrolled for Surgery
3MIndustry Sponsor
157 Previous Clinical Trials
31,059 Total Patients Enrolled
1 Trials studying Surgery
247 Patients Enrolled for Surgery

Media Library

Prevena Spine (Vacuum-Assisted Closure Device) Clinical Trial Eligibility Overview. Trial Name: NCT05555355 — Phase 4
Surgery Research Study Groups: Group 1 (control), Group 2 (Prevena)
Surgery Clinical Trial 2023: Prevena Spine Highlights & Side Effects. Trial Name: NCT05555355 — Phase 4
Prevena Spine (Vacuum-Assisted Closure Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05555355 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this clinical trial thus far?

"Indeed, clinicaltrials.gov data indicates that this particular trial is actively recruiting subjects as of November 8th 2022. It was first posted on December 1st 2022 and 285 participants are needed to be enrolled from one location."

Answered by AI

Is recruitment for this trial still available to participants?

"As recorded on clinicaltrials.gov, the recruitment process for this trial is still ongoing since it was originally posted in December of 2022 and last updated in November later that year."

Answered by AI

What potential hazards may arise from Group 2 (Prevena) treatments?

"There is ample evidence to suggest that Group 2 (Prevena) is safe, and the trial has been given a score of 3. This marks it as being in Phase 4; thus approved for use by medical professionals."

Answered by AI
~32 spots leftby Jun 2024