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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

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ClinicalTrials.gov Identifier: NCT02267122
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : October 17, 2014
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

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.

Condition or disease Intervention/treatment Phase
Incisional Surgical Site Infections Procedure: ionic silver-containing dressing Procedure: Mupirocin ointment application Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : January 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ionic silver-containing dressing
After placing the staples, a ionic silver-containing dressing was placed covering the wound.
Procedure: ionic silver-containing dressing
After placing the staples, a ionic silver-containing dressing was placed covering the wound

Experimental: Mupirocin ointment application
After placing the staples, a Mupirocin ointment application was placed covering the wound.
Procedure: Mupirocin ointment application
After placing the staples, Mupirocin ointment application over the wound was performed

No Intervention: Conventional dressing
After placing the staples, a conventional dressing, without application of any special gauze or ointment, was placed covering the wound



Primary Outcome Measures :
  1. Incisional Surgical site infection [ Time Frame: 30 postoperative days ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Coordinator of Surgical Site Infections, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT02267122     History of Changes
Other Study ID Numbers: Hospital General Elche
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: October 17, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action