Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Surgical Site Infection

Treatments: Drug: Vitamin E ointment application

Study type: Interventional

Funder types: Other

Identifiers

NCT02820948

HRJC 16-6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Vitamin E ointment application

Experimental group

Description:

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.

Treatment:

Drug: Vitamin E ointment application

No Vitamin E ointment application

No Intervention group

Description:

No vitamin E ointment was performed.