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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

Tracking Information
First Submitted Date  ICMJE May 17, 2014
First Posted Date  ICMJE May 21, 2014
Last Update Posted Date May 21, 2014
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
prolongation of hospitalization [ Time Frame: 30 days ]
Length of hospital stay, and if it is prolonged as a consequence of infection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients
Official Title  ICMJE Prospective and Comparative Pilot Study Between Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients.
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Surgical Wound Infections
  • Colorectal Surgery
Intervention  ICMJE
  • Procedure: subcuticular suture
    Other Name: undyed Monocryl 4-0 (Ethicon)
  • Procedure: Skin staples
Study Arms  ICMJE
  • Experimental: Subcuticular suture
    Subcuticular suture (absorbable) for skin closure
    Intervention: Procedure: subcuticular suture
  • Active Comparator: Skin staples
    Standard skin staples for wound closure
    Intervention: Procedure: Skin staples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 20, 2014)
400
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02143336
Other Study ID Numbers  ICMJE HULP-3961
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigación Hospital Universitario La Paz
Study Sponsor  ICMJE Instituto de Investigación Hospital Universitario La Paz
Collaborators  ICMJE Surgical Infection Society Europe
Investigators  ICMJE
Principal Investigator: Ines Rubio-Perez, MD Hospital Universitario La Paz
PRS Account Instituto de Investigación Hospital Universitario La Paz
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP