Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Rate of Surgical Site Infection [Within 30 days of the operation]. Count Of Participants, Participants. Prevena Peel & Place Dressing for Wound Closure (n=62): 6; Standard Closure of the Wound (n=61): 19. Analysis, Prevena Peel & Place Dressing for Wound Closure vs Standard Closure of the Wound: p=0.003; Chi-squared; equivalence.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Prolonged Length of Stay, Measured in Days [Within 10 days of surgery]. Median, days (Inter-Quartile Range). Prevena Peel & Place Dressing for Wound Closure (n=62): 7 (7 to 10); Standard Closure of the Wound (n=61): 8 (7 to 10). Analysis, Prevena Peel & Place Dressing for Wound Closure vs Standard Closure of the Wound: p=0.23; t-test, 2 sided; equivalence.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Rate of Readmission for Surgical Site Infections (SSIs) [Within 30 days of operation]. Count Of Participants, Participants. Prevena Peel & Place Dressing for Wound Closure (n=62): 3; Standard Closure of the Wound (n=61): 6.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

30-d Readmission [Within 30 days of surgery]. Count Of Participants, Participants. Prevena Peel & Place Dressing for Wound Closure (n=62): 5; Standard Closure of the Wound (n=61): 12.