Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery

Surgical Site Infection Clinical Trial

Official title:

Effect of Subcutaneous Sterile Vitamin E Ointment on Incisional Surgical-site Infection Following Elective Laparoscopic Colorectal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820948
• Other study ID #: HRJC 16-6
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2016
• Last updated: June 30, 2016
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection		30 days postoperatively	No