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

NCT ID: NCT02267122

Last Updated: 2014-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Incisional Surgical Site Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ionic silver-containing dressing

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

Group Type EXPERIMENTAL

ionic silver-containing dressing

Intervention Type PROCEDURE

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

Mupirocin ointment application

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

Group Type EXPERIMENTAL

Mupirocin ointment application

Intervention Type PROCEDURE

After placing the staples, Mupirocin ointment application over the wound was performed

Conventional dressing

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ionic silver-containing dressing

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

Intervention Type PROCEDURE

Mupirocin ointment application

After placing the staples, Mupirocin ointment application over the wound was performed

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Coordinator of Surgical Site Infections

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 26206641 (View on PubMed)

Other Identifiers

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Hospital General Elche

Identifier Type: -

Identifier Source: org_study_id

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