Chemoradiation, Chemotherapy Effects, Pancreatic Cancer, Pancreatic Neoplasms, Surgical Site Infection, Surgical Wound, Wound Complication
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEPrevena 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
OTHERStandard Closure of the Surgical Incision
This would involve standard closure of the incision site
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Surgical Site Infection | Within 30 days of the operation | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Length of Stay, Measured in Days | Within 10 days of surgery | Length of stay of patient at the hospital from date of surgery |
| Rate of Readmission for Surgical Site Infections (SSIs) | Within 30 days of operation | Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery |
| 30-d Readmission | Within 30 days of surgery | Need for 30-day readmission |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevena Peel & Place Dressing for Wound Closure In the participants randomized to this arm the surgical site will be closed using Prevena Peel & Place Dressing.
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 | 62 |
| Standard Closure of the Wound In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site | 61 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Standard Closure of the Wound | Prevena Peel & Place Dressing for Wound Closure |
|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 9.1 | 66.1 years STANDARD_DEVIATION 9 | 66.4 years STANDARD_DEVIATION 9.3 |
| American Society of Anesthesiologists (ASA) class ASA I/II | 25 Participants | 14 Participants | 11 Participants |
| American Society of Anesthesiologists (ASA) class ASA III/IV | 98 Participants | 47 Participants | 51 Participants |
| Neoadjuvant therapy | 77 Participants | 33 Participants | 44 Participants |
| Preincisional prophylactic antibiotic | 123 Participants | 61 Participants | 62 Participants |
| Preoperative biliary stenting | 102 Participants | 51 Participants | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 102 Participants | 47 Participants | 55 Participants |
| Region of Enrollment United States | 123 Participants | 61 Participants | 62 Participants |
| Sex: Female, Male Female | 58 Participants | 27 Participants | 31 Participants |
| Sex: Female, Male Male | 65 Participants | 34 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 61 |
| other Total, other adverse events | 7 / 62 | 15 / 61 |
| serious Total, serious adverse events | 0 / 62 | 0 / 61 |
Outcome results
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)
Time frame: Within 30 days of the operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevena Peel & Place Dressing for Wound Closure | Rate of Surgical Site Infection | 6 Participants |
| Standard Closure of the Wound | Rate of Surgical Site Infection | 19 Participants |
p-value: 0.003Chi-squared
Secondary
30-d Readmission
Need for 30-day readmission
Time frame: Within 30 days of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevena Peel & Place Dressing for Wound Closure | 30-d Readmission | 5 Participants |
| Standard Closure of the Wound | 30-d Readmission | 12 Participants |
Secondary
Prolonged Length of Stay, Measured in Days
Length of stay of patient at the hospital from date of surgery
Time frame: Within 10 days of surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prevena Peel & Place Dressing for Wound Closure | Prolonged Length of Stay, Measured in Days | 7 days |
| Standard Closure of the Wound | Prolonged Length of Stay, Measured in Days | 8 days |
p-value: 0.23t-test, 2 sided
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
Time frame: Within 30 days of operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevena Peel & Place Dressing for Wound Closure | Rate of Readmission for Surgical Site Infections (SSIs) | 3 Participants |
| Standard Closure of the Wound | Rate of Readmission for Surgical Site Infections (SSIs) | 6 Participants |