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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

About this trial

This is an interventional treatment trial for Surgical Wound Infection focused on measuring Surgical Wound Infection, Electrocautery, Scalpel

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

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.

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