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

Surgical Site Infection Clinical Trial

Official title:

Effecto of Total Occlusive Vitamin E-containing Dressing on Incisional Surgical Site Infection in Elective Laparoscopic Colorectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03443141
• Other study ID #: HRJC2018-20
• Status: Recruiting
• Phase: Phase 3
• First received: February 16, 2018
• Last updated: February 16, 2018
• Start date: January 1, 2018
• Est. completion date: March 30, 2018

Study information

• Verified date: February 2018
• Source: Hospital General Universitario Elche
• Contact: Jaime Ruiz-Tovar
• Phone: 630534808
• Email: jruiztovar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Vitamin E
The applied dressing will be embebbed in Vitamin E
• Standard dressing
The applied dressing is a normal one without adding any product to it.

Locations

Country	Name	City	State
Spain	Hospital general Universitario de Elche	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional surgical site infection	Patients present a wound with the CDC criteria for SSI	30 days postoperatively