Effect of Vitamin E-containing Dressing on Surgical Site Infection in Colorectal Surgery
Effecto of Total Occlusive Vitamin E-containing Dressing on Incisional Surgical Site Infection in Elective Laparoscopic Colorectal Surgery
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2018
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 16, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2018
CompletedFebruary 22, 2018
February 1, 2018
3 months
February 16, 2018
February 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incisional surgical site infection
Patients present a wound with the CDC criteria for SSI
30 days postoperatively
Study Arms (2)
Vitamin E dressing
EXPERIMENTALPatients will receive a Vitamin E-containing dressing over the wound
Standard dressing
SHAM COMPARATORPatients will receive a standard dressing over the wound
Interventions
The applied dressing will be embebbed in Vitamin E
The applied dressing is a normal one without adding any product to it.
Eligibility Criteria
You may qualify if:
- diagnosis of colorectal neoplasms
- plan to undergo an elective operation with curative aims
- laparoscopic surgery
You may not qualify if:
- Anastomotic leak
- Lost to 30-days follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital general Universitario de Elche
Elche, Alicante, 03202, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Damian Garcia-Olmo, MD, PhD
HOSPITAL REY JUAN CARLOS
Central Study Contacts
Manuel Duran, MD, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
February 16, 2018
First Posted
February 22, 2018
Study Start
January 1, 2018
Primary Completion
March 30, 2018
Study Completion
March 30, 2018
Last Updated
February 22, 2018
Record last verified: 2018-02