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

Overview

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 Title of Study: “Effecto of Total Occlusive Vitamin E-containing Dressing on Incisional Surgical Site Infection in Elective Laparoscopic Colorectal Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 30, 2018

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

  • Drug: Vitamin E
    • The applied dressing will be embebbed in Vitamin E
  • Drug: Standard dressing
    • The applied dressing is a normal one without adding any product to it.

Arms, Groups and Cohorts

  • Experimental: Vitamin E dressing
    • Patients will receive a Vitamin E-containing dressing over the wound
  • Sham Comparator: Standard dressing
    • Patients will receive a standard dressing over the wound

Clinical Trial Outcome Measures

Primary Measures

  • Incisional surgical site infection
    • Time Frame: 30 days postoperatively
    • Patients present a wound with the CDC criteria for SSI

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital General Universitario Elche
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jaime Ruiz-Tovar, MD, PhD, Professor of Surgery – Hospital General Universitario Elche
  • Overall Official(s)
    • Damian Garcia-Olmo, MD, PhD, Study Director, HOSPITAL REY JUAN CARLOS
  • Overall Contact(s)
    • Jaime Ruiz-Tovar, 630534808, jruiztovar@gmail.com

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