Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vitamin E ointment application
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vitamin E ointment application
No Vitamin E ointment application
Arm 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.
No vitamin E ointment was performed.
Outcomes
Primary Outcome Measures
Surgical site infection
Secondary Outcome Measures
Full Information
NCT ID
NCT02820948
First Posted
June 29, 2016
Last Updated
June 30, 2016
Sponsor
Hospital General Universitario Elche
1. Study Identification
Unique Protocol Identification Number
NCT02820948
Brief Title
Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery
Official Title
Effect of Subcutaneous Sterile Vitamin E Ointment on Incisional Surgical-site Infection Following Elective Laparoscopic Colorectal Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin E ointment application
Arm Type
Experimental
Arm 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.
Arm Title
No Vitamin E ointment application
Arm Type
No Intervention
Arm Description
No vitamin E ointment was performed.
Intervention Type
Drug
Intervention Name(s)
Vitamin E ointment application
Other Intervention Name(s)
Subcutaneous sterile Vitamin E acetate ointment application
Intervention 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.
Primary Outcome Measure Information:
Title
Surgical site infection
Time Frame
30 days postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian Garcia
Organizational Affiliation
Fundacion Jimenez Diaz
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication in scientific journal
Learn more about this trial
Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery
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