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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has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 43 studies in Surgical Wound Infection with a site in Spain — 6 open to participants now, 6 under way, 1 of them phase 3. Surgical Wound Infection · Spain.

Planned enrollment
18th of 24
120 · median 224
Started
2018
with 7 others
Phase 3
5 of 43
none open now
Registered
11th of 43
by date
Lead sponsor
4 of 43
Hospital General Universitario Elche

Among the 43 studies in Surgical Wound Infection with a site in Spain, this one is the 18th largest by planned enrollment of the 24 interventional ones that give a count, is one of 8 that started in 2018, is one of 5 in phase 3, and was the 11th registered.

Surgical Wound Infection

746 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.

Browse Surgical Wound Infection studies →

Open to participants now

6 of the 43 studies in Surgical Wound Infection with a site in Spain are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 84 Surgical Wound Infection studies recruiting now, 60 (71%) set no upper age limit and 16 (19%) stop at 75 or younger; 12 take children under 18; 14 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Surgical Site Infection
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

  • 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

06

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

07

Study locations

1 of 1 sites recruiting
  • Hospital general Universitario de Elche
    Elche, Alicante 03202, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Mar 2018, 2 months after the start.

Of 38 phase 3 interventional studies under Surgical Wound Infection, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 51. This study's planned 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2018
First posted
Feb 22, 2018
StartActual
Jan 1, 2018
Primary completionEst.
Mar 30, 2018
CompletionEst.
Mar 30, 2018
Last update
Feb 22, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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Studies of the drug tested here: Vitamin E

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