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

Hospital General Universitario Elche

Status and phase: Unknown; Phase 3

Conditions: Surgical Site Infection

Treatments: Drug: Bundle; Procedure: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT03081962

HGUE-2016-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups

Bundle application

Experimental group

Description:

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

Treatment:

Procedure: Standard care

Drug: Bundle

Standard care

Active Comparator group

Description:

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).

Treatment:

Procedure: Standard care