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

Primary Purpose

Surgical Site Infection

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Vitamin E
Standard dressing
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital general Universitario de ElcheRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Vitamin E dressing

Standard dressing

Arm Description

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

Patients will receive a standard dressing over the wound

Outcomes

Primary Outcome Measures

Incisional surgical site infection
Patients present a wound with the CDC criteria for SSI

Secondary Outcome Measures

Full Information

First Posted
February 16, 2018
Last Updated
February 16, 2018
Sponsor
Hospital General Universitario Elche
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1. Study Identification

Unique Protocol Identification Number
NCT03443141
Brief Title
Effect of Vitamin E-containing Dressing on Surgical Site Infection in Colorectal Surgery
Official Title
Effecto of Total Occlusive Vitamin E-containing Dressing on Incisional Surgical Site Infection in Elective Laparoscopic Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 30, 2018 (Anticipated)
Study Completion Date
March 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin E dressing
Arm Type
Experimental
Arm Description
Patients will receive a Vitamin E-containing dressing over the wound
Arm Title
Standard dressing
Arm Type
Sham Comparator
Arm Description
Patients will receive a standard dressing over the wound
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Other Intervention Name(s)
Exerimental group
Intervention Description
The applied dressing will be embebbed in Vitamin E
Intervention Type
Drug
Intervention Name(s)
Standard dressing
Other Intervention Name(s)
Control group
Intervention Description
The applied dressing is a normal one without adding any product to it.
Primary Outcome Measure Information:
Title
Incisional surgical site infection
Description
Patients present a wound with the CDC criteria for SSI
Time Frame
30 days postoperatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Ruiz-Tovar
Phone
630534808
Email
jruiztovar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Duran, MD, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian Garcia-Olmo, MD, PhD
Organizational Affiliation
HOSPITAL REY JUAN CARLOS
Official's Role
Study Director
Facility Information:
Facility Name
Hospital general Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar, MD, PhD
Phone
0034-630534808
Email
jruiztovar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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