Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery

NCT ID: NCT02820948

Last Updated: 2016-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-03-31

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.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vitamin E ointment application

Intervention Type: 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.

No Vitamin E ointment application

No vitamin E ointment was performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Subcutaneous sterile Vitamin E acetate ointment application

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Universitario Elche

OTHER

Sponsor Role: lead

Responsible Party

Jaime Ruiz-Tovar, MD, PhD

David Alias

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Damian Garcia

Role: STUDY_DIRECTOR

Fundacion Jimenez Diaz

Other Identifiers

HRJC 16-6

Identifier Type: -

Identifier Source: org_study_id