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Trial record 18 of 287 for:    Panama

Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.

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: NCT02332252
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Tracking Information
First Submitted Date  ICMJE January 4, 2015
First Posted Date  ICMJE January 6, 2015
Last Update Posted Date January 4, 2018
Study Start Date  ICMJE August 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2015)
Surgical Site Infection [ Time Frame: 8 days ]
Presence of signs of surgical site infection after cesarean section.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2015)
Post operative pain [ Time Frame: 8 days ]
Post operative pain using a visual scale after surgery.
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 Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.
Official Title  ICMJE Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section. A Randomized Controlled Trial.
Brief Summary To determine the risk of surgical site infection after surgical skin incision, comparing electrocautery vs. scalpel.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Surgical Wound Infection
Intervention  ICMJE
  • Device: Scalpel
    Skin incision performed with a scalpel during cesarean section.
  • Device: Electrocautery
    Skin incision performed with an electrocautery during cesarean section.
  • Procedure: Skin incision
Study Arms  ICMJE
  • Active Comparator: Scalpel
    Skin incision performed with a scalpel during cesarean section.
    Interventions:
    • Device: Scalpel
    • Procedure: Skin incision
  • Experimental: Electrocautery
    Skin incision performed with an electrocautery during cesarean section.
    Interventions:
    • Device: Electrocautery
    • Procedure: Skin incision
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2018)
500
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2015)
1000
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Elective Cesarean section, regardless of gestational age.

Exclusion Criteria:

  • Skin infection in the cesarean section area.
  • Emergency cesarean section.
  • Presence of a maternal pathology that increases the risk of infection (immunocompromised state).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, 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 Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02332252
Other Study ID Numbers  ICMJE MHST2014-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Study Sponsor  ICMJE Saint Thomas Hospital, Panama
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Osvaldo Reyes, MD Saint Thomas Hospital, Panama
PRS Account Saint Thomas Hospital, Panama
Verification Date January 2018

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