N/A
N=124
Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections
Surgical Site Infection · Pancreatic Neoplasms · Pancreatic Cancer · Chemotherapy Effects · Chemoradiation
Bottom Line
View on ClinicalTrials.gov: NCT03021668 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Rate of Surgical Site Infection — 6; 19 Participants — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prevena Peel & Place Dressing (Device); Standard Closure of the Surgical Incision (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Surgical Site Infection |
6; 19 | 0.003 sig |
| SECONDARY Prolonged Length of Stay, Measured in Days |
7; 8 | 0.23 |
| SECONDARY Rate of Readmission for Surgical Site Infections (SSIs) |
3; 6 | — |
| SECONDARY 30-d Readmission |
5; 12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patient to undergo pancreaticoduodenectomy for pancreatic tumors at the Johns Hopkins Hospital
- Patient treated with neoadjuvant chemotherapy with or without radiation therapy prior to surgical resection, AND/OR placement of a biliary stent and/or drain for biliary tree decompression
Exclusion Criteria
- Age 18 years or younger
- Laparoscopic or robotic pancreaticoduodenectomy
- Patient did not undergo either placement of a preoperative biliary stent/drain or neoadjuvant chemotherapy with or without radiation therapy
- All patients who are have known allergies or are sensitive to silver and acrylic adhesives
Data sourced from ClinicalTrials.gov (NCT03021668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.