NCT03081962

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

June 27, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

March 7, 2017

Last Update Submit

June 25, 2017

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • Incisional surgical site infection

    Incisional surgical site infection will be evaluated up to the 30th postoperative day by an epidemiology nurse.

    30 days postoperatively

Study Arms (2)

Bundle application

EXPERIMENTAL

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

Drug: BundleProcedure: Standard care

Standard care

ACTIVE COMPARATOR

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).

Procedure: Standard care

Interventions

BundleDRUG

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

Also known as: Combination of 3 measures for SSI prevention
Bundle application
Standard carePROCEDURE

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).

Also known as: Standard care measures for SSI prevention
Bundle applicationStandard care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with colorectal cancer undergoing elective laparoscopic colorectal surgery with curative aims.

You may not qualify if:

  • Chronic renal failure
  • Immunodeficiency status, including uncontrolled Type 2 diabetes mellitus and patients under corticoid or immunosuppresive treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Elche

Elche, Alicante, 03203, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29349539DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Carolina Llavero

    Hospital General Elche

    STUDY DIRECTOR

Central Study Contacts

Jaime Ruiz-Tovar

CONTACT

(0034)630534808jruiztovar@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The election of the intervention will be performed following a randomization model. Only the care provider will know the assigned group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 17, 2017

Study Start

February 15, 2017

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

June 27, 2017

Record last verified: 2017-03

Locations

ES(1)