Surgical Site Infection
Conditions
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.
Interventions
DRUGVitamin E
The applied dressing will be embebbed in Vitamin E
The applied dressing is a normal one without adding any product to it.
Sponsors
Hospital General Universitario Elche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional surgical site infection | 30 days postoperatively | Patients present a wound with the CDC criteria for SSI |
Countries
Spain
Contacts
Primary ContactJaime Ruiz-Tovar
Backup ContactManuel Duran, MD, PhD
Outcome results
None listed