An interventional study of Prevena in Surgical Wound Infection, sponsored by Icahn School of Medicine at Mount Sinai. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Prevention
The purpose of this study is to see if the Negative Pressure Wound Therapy (NPWT) system is effective and safe for the prevention of superficial and deep incisional surgical site infections (SSI) in high risk patients within 30 days after elective colorectal surgery. It has been shown that patients with an IBD, patients undergoing a reoperation or patients with certain comorbidities are at a higher risk of developing an SSI. The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds. The study will include up to 400 patients at this single site, where these high risk patients will be randomized to receive either one of two arms. The first arm involves the placement of the NPWT device in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures. The device would then be left on for 5 days. The second arm would be standard of care and would entail routine postoperative protocols. Subjects will then be seen once at a 30 day (± 7 days) follow-up visit to assess for the development of SSIs.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 7 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will receive the negative pressure wound therapy device.
Device: Prevena
This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.
The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.
Also known as: Negative pressure wound therapy device
Incidence of Surgical Site Infection
Any type of Surgical site infection as defined by the CDC developed within the follow-up period.
Time frame: 37 days
Length of Hospital Stay
Time frame: average of 7 days
Number of Serious Adverse Events
Number of serious adverse events developed within the follow-up period
Time frame: up to 37 days
Participants were recruited from August 2018 - December 2018
| Milestone | Prevena | Standard of Care |
|---|---|---|
| Started | 2 | 5 |
| Completed | 2 | 5 |
| Not completed | 0 | 0 |
Any type of Surgical site infection as defined by the CDC developed within the follow-up period.
| incidences | Prevena | Standard of Care |
|---|---|---|
| Incidence of Surgical Site Infection | 2 | 4 |
| days | Prevena | Standard of Care |
|---|---|---|
| Length of Hospital Stay | 7 ± 1.00 | 7.8 ± 2.71 |
Number of serious adverse events developed within the follow-up period
| events | Prevena | Standard of Care |
|---|---|---|
| Number of Serious Adverse Events | 0 | 0 |
Collected over 37 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prevena | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Standard of Care | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Prevena | Standard of Care | Total |
|---|---|---|---|
| Mean | 55.5 ± 13.44 | 68.4 ± 8.38 | 64.7 ± 9.996 |
| Sex: Female, Male(Participants) | Prevena | Standard of Care | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 0 | 3 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Prevena | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 5 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Prevena | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 4 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Plan to share: No
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Icahn School of Medicine at Mount Sinai