Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery

Phase 3

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: Vitamin E ointment application

• Registration Number: NCT02820948
• Lead Sponsor: Hospital General Universitario Elche

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.

Detailed Description

A prospective, randomized study was performed. The patients were randomized into 2 groups: those patients undergoing a subcutaneous sterile vitamin E acetate ointment application (Group 1) and those patients who did not receive this vitamin E ointment application (Group 2).

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

Incisional SSI, microbiological cultures from the infected surgical wounds, postoperative pain was evaluated 24 hours after surgery by means of a Visual Analogic Scale (VAS), ranging from 0 mm (complete absence of pain) to 100 mm (unbearable pain) and acute phase reactants (white cell count (WBC), fibrinogen and C reactive protein) 48 hours after surgery were investigated.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-06
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-06-30
• Last Update Submitted: 2016-06-30
• Study First Posted: 2016-07-01
• Last Update Posted: 2016-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin E ointment application	Vitamin E ointment application	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.

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days postoperatively