Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.
Primary Purpose
Surgical Wound Infection
Status
Completed
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Scalpel
Electrocautery
Skin incision
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Wound Infection focused on measuring Surgical Wound Infection, Electrocautery, Scalpel
Eligibility Criteria
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).
Sites / Locations
- Saint Thomas H
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Scalpel
Electrocautery
Arm Description
Skin incision performed with a scalpel during cesarean section.
Skin incision performed with an electrocautery during cesarean section.
Outcomes
Primary Outcome Measures
Surgical Site Infection
Presence of signs of surgical site infection after cesarean section.
Secondary Outcome Measures
Post operative pain
Post operative pain using a visual scale after surgery.
Full Information
NCT ID
NCT02332252
First Posted
January 4, 2015
Last Updated
January 2, 2018
Sponsor
Saint Thomas Hospital, Panama
1. Study Identification
Unique Protocol Identification Number
NCT02332252
Brief Title
Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.
Official Title
Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the risk of surgical site infection after surgical skin incision, comparing electrocautery vs. scalpel.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Surgical Wound Infection, Electrocautery, Scalpel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scalpel
Arm Type
Active Comparator
Arm Description
Skin incision performed with a scalpel during cesarean section.
Arm Title
Electrocautery
Arm Type
Experimental
Arm Description
Skin incision performed with an electrocautery during cesarean section.
Intervention Type
Device
Intervention Name(s)
Scalpel
Intervention Description
Skin incision performed with a scalpel during cesarean section.
Intervention Type
Device
Intervention Name(s)
Electrocautery
Intervention Description
Skin incision performed with an electrocautery during cesarean section.
Intervention Type
Procedure
Intervention Name(s)
Skin incision
Primary Outcome Measure Information:
Title
Surgical Site Infection
Description
Presence of signs of surgical site infection after cesarean section.
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Post operative pain
Description
Post operative pain using a visual scale after surgery.
Time Frame
8 days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osvaldo Reyes, MD
Organizational Affiliation
Saint Thomas Hospital, Panama
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Thomas H
City
Panama
Country
Panama
12. IPD Sharing Statement
Learn more about this trial
Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.
We'll reach out to this number within 24 hrs