Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02820948

Enrollment

108

Registered

2016-07-01

Start date

2015-01-31

Completion date

2016-03-31

Last updated

2016-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

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.

Interventions

DRUGVitamin 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Surgical site infection	30 days postoperatively

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026