Effect of Vitamin E-containing Dressing on Surgical Site Infection in Colorectal Surgery
- Registration Number
- NCT03443141
- Lead Sponsor
- Hospital General Universitario Elche
- Brief Summary
A prospective, randomized study will be performed. Patients are randomized using a 1:1 allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a conventional dressing (group 2). The primary outcomes variable will be occurrence of incisional SSI. Follow-up will be 30 days postoperatively.
- Detailed Description
A prospective, randomized study will be performed. Patients are randomized using a random number table into 1:1 allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a conventional dressing (group 2). In group 1 the wound will be covered with a Vitamin E embebbed gauze and plastic adhesive tape. In Group 2, , the wound will be covered with standard gauze and plastic adhesive tape.
The primary outcomes variable will be occurrence of incisional SSI, defined by CDC criteria. Follow-up will be 30 days postoperatively.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- diagnosis of colorectal neoplasms
- plan to undergo an elective operation with curative aims
- laparoscopic surgery
- Anastomotic leak
- Lost to 30-days follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard dressing Standard dressing Patients will receive a standard dressing over the wound Vitamin E dressing Vitamin E Patients will receive a Vitamin E-containing dressing over the wound
- Primary Outcome Measures
Name Time Method Incisional surgical site infection 30 days postoperatively Patients present a wound with the CDC criteria for SSI
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital general Universitario de Elche
🇪🇸Elche, Alicante, Spain