Clinical trial · Interventional
Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections
A Randomized Control Trial of Prevena Peel & Place Dressing Versus Standard Closure for Patients Undergoing Pancreaticoduodenectomy Who Have Undergone Neoadjuvant Chemotherapy or Biliary Stent Placement
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiation | — | UNRESOLVED | — |
| Chemotherapy Effects | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Surgical Site Infection | — | UNRESOLVED | — |
| Surgical Wound | — | UNRESOLVED | — |
| Wound Complication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prevena Peel & Place Dressing | Device | — | UNRESOLVED |
| Standard Closure of the Surgical Incision | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prevena Peel & Place Dressing for wound closure
- description
- In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.
- interventionNames
- Device: Prevena Peel & Place Dressing
- type
- PLACEBO_COMPARATOR
- label
- Standard closure of the wound
- description
- In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
- interventionNames
- Other: Standard Closure of the Surgical Incision
Primary outcomes (1)
- measure
- Rate of Surgical Site Infection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available