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Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients

Primary Purpose

Surgical Wound Infections, Colorectal Surgery

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

subcuticular suture

Skin staples

About this trial

This is an interventional prevention trial for Surgical Wound Infections focused on measuring Surgical site infections, Skin closure techniques, Colorectal surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults (age >18), both genders.
Elective colorectal surgery interventions
Open surgery incisions and laparoscopic extraction incisions
Incisions >5cm, any location
Intervention performed by a specialist colorectal surgeon
Patient suitable for surgery in preoperative assessment
Informed consent

Exclusion Criteria:

Emergency colorectal surgery
Scheduled multiple surgical procedures
Unsuitable preoperative assessment
Other infections present/being treated.
Incorrect application of standard surgical infection prevention measures (antibiotic prophylaxis, antibiotic treatment prior to surgery, intraoperative heat/O2/glycemic control,etc.)
Inability to understand the study/sign informed consent

Sites / Locations

Hospital Fundacion Jimenez DiazRecruiting
Hospital Universitario La PazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subcuticular suture

Skin staples

Arm Description

Subcuticular suture (absorbable) for skin closure

Standard skin staples for wound closure

Outcomes

Primary Outcome Measures

incidence of surgical site infection

The primary endpoint is the incidence of wound infection, measured from the moment of surgery up to 30 days postoperatively.

Secondary Outcome Measures

prolongation of hospitalization

Length of hospital stay, and if it is prolonged as a consequence of infection

Full Information

NCT ID

NCT02143336

First Posted

May 17, 2014

Last Updated

May 20, 2014

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Surgical Infection Society Europe

1. Study Identification

Unique Protocol Identification Number

NCT02143336

Brief Title

Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients

Official Title

Prospective and Comparative Pilot Study Between Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Surgical Infection Society Europe

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A comparison of skin closure techniques (standard skin closure with staples versus a continuous (subcuticular) absorbable suture), to determine if this changes the rate of post operative wound infections in elective colorectal surgery patients.

Detailed Description

In colorectal surgery, there has been a growing interest in the study of Surgical Site Infections (SSI), with an outstanding variability of reported incidence, ranging from 3% up to 30% depending on the series. Although general risk factors for infection have been identified, there is still a need to identify specific risk factors for colorectal surgery patients, to try to reduce these numbers. The technique and materials used for wound closure have been considered as interesting variables for study. Main question of our study: is subcuticular (reabsorbable, continuous) suture better than skin staples for reducing wound SSIs in colorectal surgery? The study is sponsored by the Surgical Infection Society Europe, and was awarded the SIS-E Fellowship for young investigators (2013)

6. Conditions and Keywords

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

Surgical Wound Infections, Colorectal Surgery

Keywords

Surgical site infections, Skin closure techniques, Colorectal surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Subcuticular suture

Arm Type

Experimental

Arm Description

Subcuticular suture (absorbable) for skin closure

Arm Title

Skin staples

Arm Type

Active Comparator

Arm Description

Standard skin staples for wound closure

Intervention Type

Procedure

Intervention Name(s)

subcuticular suture

Other Intervention Name(s)

undyed Monocryl 4-0 (Ethicon)

Intervention Type

Procedure

Intervention Name(s)

Skin staples

Primary Outcome Measure Information:

Title

incidence of surgical site infection

Description

The primary endpoint is the incidence of wound infection, measured from the moment of surgery up to 30 days postoperatively.

Time Frame

30 days, as by CDC definition

Secondary Outcome Measure Information:

Title

prolongation of hospitalization

Description

Length of hospital stay, and if it is prolonged as a consequence of infection

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults (age >18), both genders. Elective colorectal surgery interventions Open surgery incisions and laparoscopic extraction incisions Incisions >5cm, any location Intervention performed by a specialist colorectal surgeon Patient suitable for surgery in preoperative assessment Informed consent Exclusion Criteria: Emergency colorectal surgery Scheduled multiple surgical procedures Unsuitable preoperative assessment Other infections present/being treated. Incorrect application of standard surgical infection prevention measures (antibiotic prophylaxis, antibiotic treatment prior to surgery, intraoperative heat/O2/glycemic control,etc.) Inability to understand the study/sign informed consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ines Rubio Perez, MD

dr.inesrubio@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ines Rubio-Perez, MD

Organizational Affiliation

Hospital Universitario La Paz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Fundacion Jimenez Diaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ignacio Valverde, PhD

ivalverden@fjd.es

First Name & Middle Initial & Last Name & Degree

Hector Guadalajara, PhD

First Name & Middle Initial & Last Name & Degree

Mariano Garcia Arranz, PhD

First Name & Middle Initial & Last Name & Degree

Ignacio Valverde, PhD

First Name & Middle Initial & Last Name & Degree

Damian Garcia Olmo, PhD

First Name & Middle Initial & Last Name & Degree

Carlos Pastor

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ines Rubio-Perez, MD

dr.inesrubio@gmail.com

First Name & Middle Initial & Last Name & Degree

Miguel Leon Arellano, Resident

First Name & Middle Initial & Last Name & Degree

Isabel Prieto Nieto, PhD

First Name & Middle Initial & Last Name & Degree

Mario Álvarez Gallego, MD

First Name & Middle Initial & Last Name & Degree

Jose Luis Marijuan, PhD

First Name & Middle Initial & Last Name & Degree

Ramon Cantero, PhD

12. IPD Sharing Statement

Links:

URL

http://www.sis-e.org/

Description

Surgical Infection Society Europe, main webpage

Learn more about this trial

Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients

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