Effecto of Total Occlusive Vitamin E-containing Dressing on Incisional Surgical Site Infection in Elective Laparoscopic Colorectal Surgery
Overview
- Phase
- Phase 3
- Intervention
- Vitamin E
- Conditions
- Surgical Site Infection
- Sponsor
- Hospital General Universitario Elche
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Incisional surgical site infection
- Last Updated
- 8 years ago
Overview
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.
Investigators
Jaime Ruiz-Tovar, MD, PhD
Professor of Surgery
Hospital General Universitario Elche
Eligibility Criteria
Inclusion Criteria
- •diagnosis of colorectal neoplasms
- •plan to undergo an elective operation with curative aims
- •laparoscopic surgery
Exclusion Criteria
- •Anastomotic leak
- •Lost to 30-days follow-up
Arms & Interventions
Vitamin E dressing
Patients will receive a Vitamin E-containing dressing over the wound
Intervention: Vitamin E
Standard dressing
Patients will receive a standard dressing over the wound
Intervention: Standard dressing
Outcomes
Primary Outcomes
Incisional surgical site infection
Time Frame: 30 days postoperatively
Patients present a wound with the CDC criteria for SSI