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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143336
Recruitment Status : Unknown
Verified May 2014 by Instituto de Investigación Hospital Universitario La Paz.
Recruitment status was:  Recruiting
First Posted : May 21, 2014
Last Update Posted : May 21, 2014
Sponsor:
Collaborator:
Surgical Infection Society Europe
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Study Description
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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.

Condition or disease Intervention/treatment Phase
Surgical Wound Infections Colorectal Surgery Procedure: subcuticular suture Procedure: Skin staples Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective and Comparative Pilot Study Between Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients.
Study Start Date : September 2013
Estimated Primary Completion Date : September 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Subcuticular suture
Subcuticular suture (absorbable) for skin closure
 Procedure: subcuticular suture
Other Name: undyed Monocryl 4-0 (Ethicon)
Active Comparator: Skin staples
Standard skin staples for wound closure
 Procedure: Skin staples


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. prolongation of hospitalization [ Time Frame: 30 days ]
    Length of hospital stay, and if it is prolonged as a consequence of infection


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143336


Contacts
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Contact: Ines Rubio Perez, MD dr.inesrubio@gmail.com

Locations
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Spain
Hospital Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Contact: Ignacio Valverde, PhD       ivalverden@fjd.es   
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         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Ines Rubio-Perez, MD       dr.inesrubio@gmail.com   
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         
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Surgical Infection Society Europe
Investigators
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Principal Investigator: Ines Rubio-Perez, MD Hospital Universitario La Paz
More Information
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Additional Information:

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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT02143336    
Other Study ID Numbers: HULP-3961
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Surgical site infections
Skin closure techniques
Colorectal surgery
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Surgical Wound Infection
Wound Infection
Surgical Wound
 Disease Attributes
Pathologic Processes
Postoperative Complications
Wounds and Injuries