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NCT02332252 Clinical Trial

Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.

Surgical Wound Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02332252
Other study ID # MHST2014-10
Secondary ID
Status Completed
Phase N/A
First received January 4, 2015
Last updated January 2, 2018
Start date August 2015
Est. completion date August 2016

Study information
Verified date January 2018
Source Saint Thomas Hospital, Panama
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date August 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Scalpel
Skin incision performed with a scalpel during cesarean section.
• Electrocautery
Skin incision performed with an electrocautery during cesarean section.
Procedure:
• Skin incision

Locations
Country Name City State
Panama Saint Thomas H Panama

Sponsors (1)
Lead Sponsor Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical Site Infection Presence of signs of surgical site infection after cesarean section. 8 days
Secondary Post operative pain Post operative pain using a visual scale after surgery. 8 days
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