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

Phase 3

• Conditions: Surgical Site Infection
• Interventions: Drug: Bundle; Procedure: Standard care

• Registration Number: NCT03081962
• Lead Sponsor: Hospital General Universitario Elche

Brief 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.

Detailed Description

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 (600mg) and gentamicin (240 mg) solution in 250 ml of normal saline, fascial closure with Triclosan-impregnated polyglactin suture 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, 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 control group, the fascial closure will be performed with a polyglactin suture (without Triclosan impregnation).

Incisional surgical-site infection will be investigated.

Study Timeline

• Study Start: 2017-02-15
• Status Verified: 2017-03
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-11
• Study First Posted: 2017-03-17
• Last Update Submitted: 2017-06-25
• Last Update Posted: 2017-06-27
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Patients with colorectal cancer undergoing elective laparoscopic colorectal surgery with curative aims.

Exclusion Criteria

• Chronic renal failure
• Immunodeficiency status, including uncontrolled Type 2 diabetes mellitus and patients under corticoid or immunosuppresive treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bundle application	Bundle	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
Standard care	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).
Bundle application	Standard care	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

Primary Outcome Measures

Name	Time	Method
Incisional surgical site infection	30 days postoperatively	Incisional surgical site infection will be evaluated up to the 30th postoperative day by an epidemiology nurse.

Trial Locations

Locations (1)

General Hospital Elche; 🇪🇸 Elche, Alicante, Spain