Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Infectious Disease, Hospital, Pancreatic Cancer |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | January 2017 |
| End Date: | June 30, 2018 |
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
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.
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.
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.
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.
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
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