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NCT03021668 · ClinicalTrials.gov registry record · NA
Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 124
- Enrollment target
NCT03021668: Completed NA study, sponsored by Johns Hopkins University.
NCT03021668 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 124 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03021668, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 124 participants
- Enrollment target
Study Summary
Pancreaticoduodenectomy is associated with high perioperative morbidity, with surgical site infection (SSIs) being one of the most common complications. A retrospective study at Hopkins on SSIs in these patients identified the rate of SSIs to be 16.7% and pre-operative bile stent/drain and neoadjuvant chemotherapy were independent predictors of surgical site infection. Patients with these factors having a predicted risk of up to 32%. Another subsequent retrospective study demonstrated that the use of negative pressure wound therapy device was significantly associated with a decrease in the rate of SSIs. The hypothesis of the investigator(s) for the current study is that placement of Prevena Peel \& Place Dressing (Negative Pressure Wound Therapy, NPWT) in patients undergoing pancreaticoduodenectomy who are at high risk of SSIs will result in a significant decrease in their SSI rate.
Primary Outcome
Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)
Interventions
- DEVICE Prevena Peel & Place Dressing
- OTHER Standard Closure of the Surgical Incision
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-06-30 |
| Phase | NA |
What the finished NCT03021668 record still lists
NCT03021668 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Prevena Peel & Place Dressing is the first listed.
NCT03021668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03021668 about?
NCT03021668 is a clinical study titled "Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections". Pancreaticoduodenectomy is associated with high perioperative morbidity, with surgical site infection (SSIs) being one of the most common complications. A retrospective study at Hopkins on SSIs in these patients identified the rate of SSIs to be 16.7% and pre-operative bile stent/drain and neoadjuva...
What is the current status of trial NCT03021668?
This trial is currently completed. It is a NA study. The enrollment target is 124 participants. The study started on 2017-01. Estimated completion is 2018-06-30.
What interventions are being tested in trial NCT03021668?
The interventions under investigation include: Prevena Peel & Place Dressing (DEVICE), Standard Closure of the Surgical Incision (OTHER).
Who is sponsoring clinical trial NCT03021668?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03021668's enrollment target sits among peer trials
124 758th of 2000 higher than 1,239 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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