Clinical trial NCT03081962: Effect of a Combination of Bundles on Surgical-site Infection After Elective Colorectal Surgery
Official title: Effect of Intraperitoneal Irrigation With Antibiotic Solution, Triclosan-impregnated Sutures for Fascial Closure and Mupirocin Ointment Over the Skin Staples, on Surgical-site Infection After Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Surgical Site Infection
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incisional surgical site infection
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: General Hospital Elche
state: Alicante
Study officials:
affiliation: Hospital General Elche
name: Carolina Llavero
role: STUDY_DIRECTOR
References:
citation: 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.