Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery

NCT02820948 | Completed Phase 3 DMC

• 1 other identifier: HRJC 16-6
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

A prospective, randomized study was performed. The patients were randomized into 2 groups: those patients undergoing subcutaneous vitamin E ointment application (Group 1) and those patients who not (Group 2). Incisional surgical site infection (SSI), microbiological cultures from the infected surgical wounds, postoperative pain and acute phase reactants were investigated.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  30 days postoperatively

Study Arms (2)

Vitamin E ointment application

EXPERIMENTAL

Before the skin stapling and after the subcutaneous irrigation with normal saline, sterile Vitamin E acetate ointment was applied in the subcutaneous tissue; 2 ml were applied in the suprapubic incision and 0.5 ml in the rest of port sites.

Drug: Vitamin E ointment application

No Vitamin E ointment application

NO INTERVENTION

No vitamin E ointment was performed.

Interventions

Vitamin E ointment application DRUG

Before the skin stapling and after the subcutaneous irrigation with normal saline, sterile Vitamin E acetate ointment was applied in the subcutaneous tissue; 2 ml were applied in the suprapubic incision and 0.5 ml in the rest of port sites.

Also known as: Subcutaneous sterile Vitamin E acetate ointment application

Vitamin E ointment application

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of colorectal neoplasms and plans to undergo an elective laparoscopic surgery with curative aims

You may not qualify if:

• Open surgical approach or conversion to laparotomy
• Performance of a stoma
• Immunodepression status
• Anastomotic leak

Sponsors & Collaborators

• Hospital General Universitario Elche: lead

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Damian Garcia

  Fundacion Jimenez Diaz

  STUDY DIRECTOR

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: David Alias

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 1, 2016
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 1, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share