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

NCT ID: NCT03443141

Last Updated: 2018-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-03-30

Brief Summary

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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

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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.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vitamin E dressing

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

Group Type EXPERIMENTAL

Vitamin E

Intervention Type DRUG

The applied dressing will be embebbed in Vitamin E

Standard dressing

Patients will receive a standard dressing over the wound

Group Type SHAM_COMPARATOR

Standard dressing

Intervention Type DRUG

The applied dressing is a normal one without adding any product to it.

Interventions

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Vitamin E

The applied dressing will be embebbed in Vitamin E

Intervention Type DRUG

Standard dressing

The applied dressing is a normal one without adding any product to it.

Intervention Type DRUG

Other Intervention Names

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Exerimental group Control group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Damian Garcia-Olmo, MD, PhD

Role: STUDY_DIRECTOR

HOSPITAL REY JUAN CARLOS

Locations

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Hospital general Universitario de Elche

Elche, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jaime Ruiz-Tovar

Role: CONTACT

630534808

Manuel Duran, MD, PhD

Role: CONTACT

Facility Contacts

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Jaime Ruiz-Tovar, MD, PhD

Role: primary

0034-630534808

Other Identifiers

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HRJC2018-20

Identifier Type: -

Identifier Source: org_study_id

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