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Total Occlusive Ionic Silver-containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection

Primary Purpose

Incisional Surgical Site Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ionic silver-containing dressing
Mupirocin 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 Incisional Surgical Site Infections

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 surgery with curative aims.
  • Open surgical approach

Exclusion Criteria:

  • Anastomotic leak
  • Mortality
  • Lost to follow-up

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    ionic silver-containing dressing

    Mupirocin ointment application

    Conventional dressing

    Arm Description

    After placing the staples, a ionic silver-containing dressing was placed covering the wound.

    After placing the staples, a Mupirocin ointment application was placed covering the wound.

    After placing the staples, a conventional dressing, without application of any special gauze or ointment, was placed covering the wound

    Outcomes

    Primary Outcome Measures

    Incisional Surgical site infection

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2014
    Last Updated
    October 16, 2014
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02267122
    Brief Title
    Total Occlusive Ionic Silver-containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection
    Official Title
    Total Occlusive Ionic Silver-containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

    5. Study Description

    Brief Summary
    The patients were randomized into 3 groups: those patients undergoing a ionic silver-containing dressing (ISD) (Group 1), those undergoing a Mupirocin ointment application (MOA) (Group 2) and those using a conventional dressing (Group 3) in the surgical wound after finishing an elective colorectal surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Incisional Surgical Site Infections

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    147 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ionic silver-containing dressing
    Arm Type
    Experimental
    Arm Description
    After placing the staples, a ionic silver-containing dressing was placed covering the wound.
    Arm Title
    Mupirocin ointment application
    Arm Type
    Experimental
    Arm Description
    After placing the staples, a Mupirocin ointment application was placed covering the wound.
    Arm Title
    Conventional dressing
    Arm Type
    No Intervention
    Arm Description
    After placing the staples, a conventional dressing, without application of any special gauze or ointment, was placed covering the wound
    Intervention Type
    Procedure
    Intervention Name(s)
    ionic silver-containing dressing
    Intervention Description
    After placing the staples, a ionic silver-containing dressing was placed covering the wound
    Intervention Type
    Procedure
    Intervention Name(s)
    Mupirocin ointment application
    Intervention Description
    After placing the staples, Mupirocin ointment application over the wound was performed
    Primary Outcome Measure Information:
    Title
    Incisional Surgical site infection
    Time Frame
    30 postoperative days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of colorectal neoplasms and plans to undergo an elective surgery with curative aims. Open surgical approach Exclusion Criteria: Anastomotic leak Mortality Lost to follow-up

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26206641
    Citation
    Ruiz-Tovar J, Llavero C, Morales V, Gamallo C. Total Occlusive Ionic Silver-Containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection. J Am Coll Surg. 2015 Aug;221(2):424-9. doi: 10.1016/j.jamcollsurg.2015.04.019. Epub 2015 Apr 28.
    Results Reference
    derived

    Learn more about this trial

    Total Occlusive Ionic Silver-containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection

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