Effect of Vitamin E-containing Dressing on Surgical Site Infection in Colorectal Surgery

Hospital General Universitario Elche

Status and phase: Unknown; Phase 3

Conditions: Surgical Site Infection

Treatments: Drug: Standard dressing; Drug: Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT03443141

HRJC2018-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

Vitamin E dressing

Experimental group

Description:

Patients will receive a Vitamin E-containing dressing over the wound

Treatment:

Drug: Vitamin E

Standard dressing

Sham Comparator group

Description:

Patients will receive a standard dressing over the wound

Treatment:

Drug: Standard dressing