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

Primary Purpose

Surgical Site Infection

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Bundle
Standard care
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • General Hospital ElcheRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bundle application

Standard care

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 7, 2017
Last Updated
June 25, 2017
Sponsor
Hospital General Universitario Elche
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1. Study Identification

Unique Protocol Identification Number
NCT03081962
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The election of the intervention will be performed following a randomization model. Only the care provider will know the assigned group.
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bundle application
Arm Type
Experimental
Arm Description
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
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Bundle
Other Intervention Name(s)
Combination of 3 measures for SSI prevention
Intervention Description
Combination of antibiotic intraperitoneal irrigation with gentamicin and clindamycin solution, use of Triclosan-impregnated sutures and mupirocin application over the skin staples.
Intervention Type
Procedure
Intervention Name(s)
Standard care
Other Intervention Name(s)
Standard care measures for SSI prevention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incisional surgical site infection
Description
Incisional surgical site infection will be evaluated up to the 30th postoperative day by an epidemiology nurse.
Time Frame
30 days postoperatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Ruiz-Tovar
Phone
(0034)630534808
Email
jruiztovar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Llavero
Organizational Affiliation
Hospital General Elche
Official's Role
Study Director
Facility Information:
Facility Name
General Hospital Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar
Phone
(0034)630534808
Email
jruiztovar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29349539
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.
Results Reference
derived

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

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