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NCT02267122 Clinical Trial

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

Incisional Surgical Site Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02267122
Other study ID # Hospital General Elche
Secondary ID
Status Completed
Phase Phase 3
First received October 14, 2014
Last updated October 16, 2014
Start date January 2012
Est. completion date January 2014

Study information
Verified date October 2014
Source Hospital General Universitario Elche
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 147
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• ionic silver-containing dressing
After placing the staples, a ionic silver-containing dressing was placed covering the wound
• Mupirocin ointment application
After placing the staples, Mupirocin ointment application over the wound was performed

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital General Universitario Elche

Outcome
Type Measure Description Time frame Safety issue
Primary Incisional Surgical site infection 30 postoperative days Yes