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Effect of a Combination of Bundles on Surgical-site Infection After Elective Colorectal Surgery

NCT03081962 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2017-06-27

No results posted yet for this study

Summary

A prospective randomized clinical trial will be performed. Patients will be randomized in 2 groups. The experimental group will undergo the combined application of intraperitoneal irrigation with clindamycin and gentamicin solution, fascial closure with Triclosan-impregnated sutures and application of mupirocin ointment over the skin staples, in addition to the standard care measures. The control group undergo only the standard care measures.

Incisional surgical-site infection will be investigated.

Conditions

  • Surgical Site Infection

Interventions

DRUG

Bundle

Combination of antibiotic intraperitoneal irrigation with gentamicin and clindamycin solution, use of Triclosan-impregnated sutures and mupirocin application over the skin staples.

PROCEDURE

Standard care

Standard care measures include decontamination of the skin during surgery with chlorhexidine alcohol solution, administration of systemic antibiotic prophylaxis and application of thermal blanket to avoid hypothermia. In the standard care protocol, the fascial closure will be performed with a polyglactin suture (without Triclosan impregnation).

Sponsors & Collaborators

  • Hospital General Universitario Elche

    lead OTHER

Principal Investigators

  • Carolina Llavero · Hospital General Elche

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081962 on ClinicalTrials.gov