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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03081962
Other study ID # HGUE-2016-23
Secondary ID
Status Recruiting
Phase Phase 3
First received March 7, 2017
Last updated June 25, 2017
Start date February 15, 2017
Est. completion date August 2017

Study information

Verified date March 2017
Source Hospital General Universitario Elche
Contact Jaime Ruiz-Tovar
Phone (0034)630534808
Email jruiztovar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 102
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Intervention

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).

Locations

Country Name City State
Spain General Hospital Elche Elche Alicante

Sponsors (1)

Lead Sponsor Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incisional surgical site infection Incisional surgical site infection will be evaluated up to the 30th postoperative day by an epidemiology nurse. 30 days postoperatively
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