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

May 20, 2014 updated by: Instituto de Investigación Hospital Universitario La Paz

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Fundacion Jimenez Diaz
        • Contact:
        • Sub-Investigator:
          • Hector Guadalajara, PhD
        • Sub-Investigator:
          • Mariano Garcia Arranz, PhD
        • Sub-Investigator:
          • Ignacio Valverde, PhD
        • Sub-Investigator:
          • Damian Garcia Olmo, PhD
        • Sub-Investigator:
          • Carlos Pastor
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Sub-Investigator:
          • Miguel Leon Arellano, Resident
        • Sub-Investigator:
          • Isabel Prieto Nieto, PhD
        • Sub-Investigator:
          • Mario Álvarez Gallego, MD
        • Sub-Investigator:
          • Jose Luis Marijuan, PhD
        • Sub-Investigator:
          • Ramon Cantero, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subcuticular suture
Subcuticular suture (absorbable) for skin closure
Procedure: subcuticular suture
Other Names:
  • undyed Monocryl 4-0 (Ethicon)
Active Comparator: Skin staples
Standard skin staples for wound closure
Procedure: Skin staples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of surgical site infection
Time Frame: 30 days, as by CDC definition
The primary endpoint is the incidence of wound infection, measured from the moment of surgery up to 30 days postoperatively.
30 days, as by CDC definition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prolongation of hospitalization
Time Frame: 30 days
Length of hospital stay, and if it is prolonged as a consequence of infection
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Surgical Infection Society Europe

Investigators

  • Principal Investigator: Ines Rubio-Perez, MD, Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

May 17, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP-3961

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Surgery

Clinical Trials on subcuticular suture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe