Negative Pressure Therapy in Preventing Infection After Surgery in Patients With Colon, Rectal, Pancreatic, or Peritoneal Surface Cancer
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|ClinicalTrials.gov Identifier: NCT01656044|
Recruitment Status : Completed
First Posted : August 2, 2012
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Pancreatic Cancer Perioperative/Postoperative Complications Primary Peritoneal Cavity Cancer Rectal Cancer||Procedure: wound care management||Not Applicable|
I. To determine whether negative pressure therapy applied to closed laparotomy incisions can decrease the incidence of incisional surgical site infections in patients undergoing clean-contaminated resections for colorectal, pancreatic, and peritoneal surface malignancies compared to standard post-operative sterile gauze dressings.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive standard sterile dressing (SSD) over their closed laparotomy incision at the conclusion of their surgery.
ARM II: Patients receive negative pressure therapy (NPT) dressing over their closed laparotomy incision at the conclusion of their surgery.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||375 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Active Comparator: Arm I (SSD)
Patients receive SSD over their closed laparotomy incision at the conclusion of their surgery.
Procedure: wound care management
Experimental: Arm II (NPT)
Patients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery.
Procedure: wound care management
- Rate of incisional surgical site infection (SSI), which includes superficial incisional SSIs and deep incisional SSIs as defined by the Center of Disease Control and Prevention [ Time Frame: 30 days ]Results will be analyzed initially using descriptive statistics. The proportion of SSI in the NPT group will be compared to the standard post-operative dressing group using a chi square test of proportions.
- Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason [ Time Frame: 30 days ]
- The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656044
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Perry Shen||Wake Forest University Health Sciences|