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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03081962

Enrollment

102

Registered

2017-03-17

Start date

2017-02-15

Completion date

2017-08-31

Last updated

2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

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.

Interventions

DRUGBundle

Combination of antibiotic intraperitoneal irrigation with gentamicin and clindamycin solution, use of Triclosan-impregnated sutures and mupirocin application over the skin staples.

PROCEDUREStandard 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The election of the intervention will be performed following a randomization model. Only the care provider will know the assigned group.

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Countries

Spain

Contacts

Primary ContactJaime Ruiz-Tovar

jruiztovar@gmail.com(0034)630534808

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026