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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
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    June 29, 2016
    Last Updated
    June 30, 2016
    Sponsor
    Hospital General Universitario Elche
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    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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