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

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ClinicalTrials.gov Identifier: NCT03443141
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Vitamin E Drug: Standard dressing Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effecto of Total Occlusive Vitamin E-containing Dressing on Incisional Surgical Site Infection in Elective Laparoscopic Colorectal Surgery
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : March 30, 2018


Arm Intervention/treatment
Experimental: Vitamin E dressing
Patients will receive a Vitamin E-containing dressing over the wound
Drug: Vitamin E
The applied dressing will be embebbed in Vitamin E
Other Name: Exerimental group

Sham Comparator: Standard dressing
Patients will receive a standard dressing over the wound
Drug: Standard dressing
The applied dressing is a normal one without adding any product to it.
Other Name: Control group




Primary Outcome Measures :
  1. Incisional surgical site infection [ Time Frame: 30 days postoperatively ]
    Patients present a wound with the CDC criteria for SSI



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443141


Contacts
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Contact: Jaime Ruiz-Tovar 630534808 jruiztovar@gmail.com
Contact: Manuel Duran, MD, PhD

Locations
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Spain
Hospital general Universitario de Elche Recruiting
Elche, Alicante, Spain, 03202
Contact: Jaime Ruiz-Tovar, MD, PhD    0034-630534808    jruiztovar@gmail.com   
Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Study Director: Damian Garcia-Olmo, MD, PhD HOSPITAL REY JUAN CARLOS

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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Professor of Surgery, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT03443141     History of Changes
Other Study ID Numbers: HRJC2018-20
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents