Effect of Subcutaneous Sterile Vitamin E Ointment on Incisional Surgical-site Infection Following Elective Laparoscopic Colorectal Cancer Surgery
Overview
- Phase
- Phase 3
- Intervention
- Vitamin E ointment application
- Conditions
- Surgical Site Infection
- Sponsor
- Hospital General Universitario Elche
- Enrollment
- 108
- Primary Endpoint
- Surgical site infection
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Jaime Ruiz-Tovar, MD, PhD
David Alias
Hospital General Universitario Elche
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
Arms & 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: Vitamin E ointment application
Outcomes
Primary Outcomes
Surgical site infection
Time Frame: 30 days postoperatively