Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03021668
Other study ID # IRB00109564
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date June 30, 2018

Study information

Verified date August 2019
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Although outcomes of pancreaticoduodenectomy have improved, it remains a procedure with a high perioperative complication rate. Surgical site infection is one of the most common complications after pancreaticoduodenectomy. In a retrospective review of all patients who underwent pancreaticoduodenectomy at Johns Hopkins between 9/2011 and 8/2014, a total of 679 patients, 30-day surgical site infection was observed in 16.7%. By univariate analysis, perioperative blood transfusion, operative time greater than 7 hours, preoperative chemotherapy and/or radiation, bile stent, absence of a superficial wound vacuum closure device, and vascular resection were associated with surgical site infection (all, p<0.05). On multivariable analysis, pre-operative bile stent/drain and neoadjuvant chemotherapy were independent predictors of surgical site infection (all, p<0.001). Studies in colorectal patients have found an estimated cost of up to $1400 per patient secondary to prolonged hospitalization, wound care, and wound complications in patients with procedures complicated by a surgical site infection. Furthermore, in another study of 1144 patients undergoing pancreaticoduodenectomy between 1995 and 2011 at Johns Hopkins Hospital, post-operative complications delayed time to adjuvant therapy, decreased median survival.

The hypothesis of the investigator(s) is that placement of Prevena Peel & Place Dressing using the standard Acelity vacuum dressing after suture on patients undergoing pancreaticoduodenectomy at highest risk of infection will result in a significant decrease in surgical site infection rate. The investigator(s) plan to perform a randomized control trial where the patients who have had pre-operative bile stent/drain placement and/or neoadjuvant chemotherapy will undergo closure with Prevena Peel & Place Dressing using the standard Acelity vacuum dressing after suture versus standard closure. The investigator(s) will then follow the participant(s) for 30 days postoperatively to determine surgical site infection and other perioperative complication rate.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date June 30, 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Prevena Peel & Place Dressing
Prevena Peel & Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
Other:
Standard Closure of the Surgical Incision
This would involve standard closure of the incision site

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Surgical Site Infection 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) Within 30 days of the operation
Secondary Prolonged Length of Stay, Measured in Days Length of stay of patient at the hospital from date of surgery Within 10 days of surgery
Secondary Rate of Readmission for Surgical Site Infections (SSIs) Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery Within 30 days of operation
Secondary 30-d Readmission Need for 30-day readmission Within 30 days of surgery
See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT04927780 - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Phase 3
Recruiting NCT06054984 - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Terminated NCT03140670 - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy Phase 2
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05168527 - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05391126 - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care N/A
Terminated NCT03300921 - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer Phase 1
Completed NCT03153410 - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas Early Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT05679583 - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Recruiting NCT04183478 - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer Phase 2/Phase 3
Terminated NCT03600623 - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Completed NCT04290364 - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study