Effect of a Combination of Bundles on Surgical-site Infection After Elective Colorectal Surgery
NCT ID: NCT03081962
Last Updated: 2017-06-27
Study Results
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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UNKNOWN
PHASE3
102 participants
INTERVENTIONAL
2017-02-15
2017-08-31
Brief Summary
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Incisional surgical-site infection will be investigated.
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Detailed Description
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Incisional surgical-site infection will be investigated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Bundle application
The patients in this group will undergo an intraperitoneal irrigation with clindamycin and gentamicin solution, fascial closure with triclosan impregnated sutures and application of Mupirocin ointment over the skin staples
Bundle
Combination of antibiotic intraperitoneal irrigation with gentamicin and clindamycin solution, use of Triclosan-impregnated sutures and mupirocin application over the skin staples.
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).
Standard care
The patients in this group will follow a standard care, including 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, the fascial closure will be performed with a polyglactin suture (without Triclosan impregnation).
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).
Interventions
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Bundle
Combination of antibiotic intraperitoneal irrigation with gentamicin and clindamycin solution, use of Triclosan-impregnated sutures and mupirocin application over the skin staples.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Immunodeficiency status, including uncontrolled Type 2 diabetes mellitus and patients under corticoid or immunosuppresive treatment
ALL
No
Sponsors
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Hospital General Universitario Elche
OTHER
Responsible Party
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Jaime Ruiz-Tovar, MD, PhD
Principal Investigator
Principal Investigators
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Carolina Llavero
Role: STUDY_DIRECTOR
Hospital General Elche
Locations
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General Hospital Elche
Elche, Alicante, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Ruiz-Tovar J, Llavero C, Morales V, Gamallo C. Effect of the application of a bundle of three measures (intraperitoneal lavage with antibiotic solution, fascial closure with Triclosan-coated sutures and Mupirocin ointment application on the skin staples) on the surgical site infection after elective laparoscopic colorectal cancer surgery. Surg Endosc. 2018 Aug;32(8):3495-3501. doi: 10.1007/s00464-018-6069-4. Epub 2018 Jan 18.
Other Identifiers
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HGUE-2016-23
Identifier Type: -
Identifier Source: org_study_id
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