SURG-DUKE-CEPPA-VAC; A Randomized Phase II Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery
Investigating Surgical Site Infection Rates with Different Wound Therapies
Brief description of study.
The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy.
Detailed description of study
The purpose of this study is to evaluate whether incisional negative pressure wound therapy (NPWT) can help reduce the rate of surgical site infections in patients undergoing either colorectal or hepatopancreatobiliary surgery.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: colorectal surgery
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction
Exclusion Criteria
The need for emergency surgery
The need for use of only laparoscopic surgery
Presence of bowel obstruction, strangulation, peritonitis or perforation
The presence of local or systemic infection preoperatively
ASA class >=4
Inability to provide informed consent and authorization
Known allergy or hypersensitivity to silver
Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study
The purpose of this study is to evaluate if using incisional negative pressure wound therapy (NPWT) can reduce the rate of infections at the site of surgery. This study focuses on patients who are undergoing colorectal or hepatopancreatobiliary surgeries. Surgical site infections are infections that occur after surgery in the part of the body where the surgery took place. Negative pressure wound therapy involves using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of second and third degree burns.
Participants in this study will be divided into two study arms. One arm will receive traditional wound care, while the other will receive negative pressure wound therapy after their surgeries. This study will help determine if negative pressure wound therapy is more effective at reducing surgical site infections compared to traditional methods.
- Who can participate: Individuals scheduled for elective colorectal or hepatopancreatobiliary surgeries, such as hemicolectomy or pancreatectomy, may participate. Participants must not require emergency or laparoscopic surgery and should not have pre-existing infections or severe medical conditions.
- Study details: Participants will be assigned to either traditional wound care or negative pressure wound therapy after surgery. Negative pressure wound therapy uses a vacuum dressing to help wounds heal. The study will compare the infection rates between these two methods.