NCT03081962

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Hospital General Universitario Elche · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-02-15
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2017-03-17
• Last updated: 2017-06-27

Locations

1 site across 1 country: Spain