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Status unknownNCT03443141Updated Feb 22, 2018

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

A Phase 3 interventional study of Vitamin E and Standard dressing in Surgical Site Infection, sponsored by Hospital General Universitario Elche. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Hospital General Universitario Elche · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosis of colorectal neoplasms
  • plan to undergo an elective operation with curative aims
  • laparoscopic surgery

Exclusion criteria

Exclusion Criteria:

  • Anastomotic leak
  • Lost to 30-days follow-up
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Vitamin E dressing

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

    Drug: Vitamin E

  • Sham comparator
    Standard dressing

    Patients will receive a standard dressing over the wound

    Drug: Standard dressing

Interventions

  • DrugVitamin E

    The applied dressing will be embebbed in Vitamin E

    Also known as: Exerimental group

  • DrugStandard dressing

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

    Also known as: Control group

05

What researchers measure

Primary outcomes

  1. Incisional surgical site infection

    Patients present a wound with the CDC criteria for SSI

    Time frame: 30 days postoperatively

06

Study locations

1 of 1 sites recruiting
  • Hospital general Universitario de Elche
    Elche, Alicante 03202, Spain
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03443141
Lead sponsor
Hospital General Universitario Elche
Responsible party
Jaime Ruiz-Tovar, MD, PhD (Professor of Surgery, Hospital General Universitario Elche) — Principal investigator
First posted
Feb 22, 2018
Start date
Jan 1, 2018
Primary completion
Mar 30, 2018 (estimated)
Completion
Mar 30, 2018 (estimated)
Last update
Feb 22, 2018

Study contacts

Jaime Ruiz-Tovar
Contact
jruiztovar@gmail.com
630534808
Manuel Duran, MD, PhD
Contact
Damian Garcia-Olmo, MD, PhD
study director · HOSPITAL REY JUAN CARLOS

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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