Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.

January 2, 2018 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section. A Randomized Controlled Trial.

To determine the risk of surgical site infection after surgical skin incision, comparing electrocautery vs. scalpel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

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

  • Panama
      • Panama, Panama
        • Saint Thomas H

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Scalpel
Skin incision performed with a scalpel during cesarean section.
Device: Scalpel
Skin incision performed with a scalpel during cesarean section.
Procedure: Skin incision
Experimental: Electrocautery
Skin incision performed with an electrocautery during cesarean section.
Procedure: Skin incision
Device: Electrocautery
Skin incision performed with an electrocautery during cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection
Time Frame: 8 days
Presence of signs of surgical site infection after cesarean section.
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: 8 days
Post operative pain using a visual scale after surgery.
8 days

Collaborators and Investigators

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

Sponsor

Saint Thomas Hospital, Panama

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

August 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 4, 2015

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Actual)

January 4, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST2014-10

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.

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