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NCT03661814 · ClinicalTrials.gov registry record · NA
Prophylactic NPWT to Reduce SSI in Colorectal Surgery
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT03661814: Clinical Trial NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03661814 is a NA study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03661814, a NA study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Any type of Surgical site infection as defined by the CDC developed within the follow-up period.
Interventions
- DEVICE Prevena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-08-13 |
| Est. Completion | 2019-01-28 |
| Phase | NA |
Why NCT03661814 stopped before completion
NCT03661814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Prevena is the first listed.
NCT03661814 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03661814 about?
NCT03661814 is a clinical study titled "Prophylactic NPWT to Reduce SSI in Colorectal Surgery". 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 ...
What is the current status of trial NCT03661814?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2018-08-13. Estimated completion is 2019-01-28.
What interventions are being tested in trial NCT03661814?
The interventions under investigation include: Prevena (DEVICE).
Who is sponsoring clinical trial NCT03661814?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03661814's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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