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NCT01924884 · ClinicalTrials.gov registry record
Surgical Site Infection Rate After Intra-Abdominal Surgery Using Negative Pressure Wound Therapy at Initial Closure
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 400
- Enrollment target
NCT01924884: Completed study, sponsored by Johns Hopkins University.
NCT01924884 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 400 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01924884 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 400 participants
- Enrollment target
Study Summary
The goal of this study is to present a large single-institution experience reporting surgical site infection rates in patients who have undergone intra-abdominal surgery followed by wound closure with Negative Pressure Wound Therapy. A retrospective review of patients' charts will be conducted to analyze surgical site infection rates between wound closure with and without Negative Pressure Wound Therapy (NPWT). American College of Surgeons National Quality Improvement Program data from previous standard of care (primary closure after colorectal surgery) will be used for comparison with newly adopted standard of care treatment regimen (wound closure with NPWT). Data on patients who underwent intra-abdominal surgery will be retrospectively collected and a database will be created. These individuals will be identified through medical records and recontacted by mail and/or phone to collect study data. Finally, patients newly referred to the Principal Investigator for intra-abdominal surgery will be enrolled in the database. After giving informed consent, data on surgical site infection rates and outcomes will be collected. Longitudinal outcomes will be assessed at 30 days, 6 months, and 12 months post-operatively. These patients' outcomes will be compared to a group of patients treated by the Principal Investigator who also underwent intra-abdominal surgery without Negative Pressure Wound Therapy. We hypothesize that fewer patients treated with negative pressure wound therapy following intra-abdominal surgery will develop surgical site infections than patients who had intra-abdominal surgery but were not treated with Negative Pressure Wound Therapy.
Primary Outcome
Comparing surgical site infection (per the 1999 Guideline for Prevention of Surgical Site Infection from the Hospital Infections Program at the National Center for Infectious Diseases) rates between patients treated with and without negative pressure wound therapy. Objective: To determine if a newly adopted standard of care \[negative pressure wound therapy (NPWT)\] for clean, clean-contaminated, and contaminated wounds will lead to decreased rates of post-operative surgical site infection.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2013-07 |
| Est. Completion | 2019-10 |
What the finished NCT01924884 record still lists
NCT01924884 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01924884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01924884 about?
NCT01924884 is a clinical study titled "Surgical Site Infection Rate After Intra-Abdominal Surgery Using Negative Pressure Wound Therapy at Initial Closure". The goal of this study is to present a large single-institution experience reporting surgical site infection rates in patients who have undergone intra-abdominal surgery followed by wound closure with Negative Pressure Wound Therapy. A retrospective review of patients' charts will be conducted to an...
What is the current status of trial NCT01924884?
This trial is currently completed. The enrollment target is 400 participants. The study started on 2013-07. Estimated completion is 2019-10.
Who is sponsoring clinical trial NCT01924884?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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