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Trial record 18 of 283 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

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

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Device: Scalpel Device: Electrocautery Procedure: Skin incision Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section. A Randomized Controlled Trial.
Study Start Date : August 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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.
Device: Electrocautery
Skin incision performed with an electrocautery during cesarean section.

Procedure: Skin incision



Primary Outcome Measures :
  1. Surgical Site Infection [ Time Frame: 8 days ]
    Presence of signs of surgical site infection after cesarean section.


Secondary Outcome Measures :
  1. Post operative pain [ Time Frame: 8 days ]
    Post operative pain using a visual scale after surgery.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332252


Locations
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Panama
Saint Thomas H
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
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Principal Investigator: Osvaldo Reyes, MD Saint Thomas Hospital, Panama

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Responsible Party: Osvaldo A. Reyes T., Coordinator of research, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT02332252     History of Changes
Other Study ID Numbers: MHST2014-10
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Surgical Wound Infection
Electrocautery
Scalpel
Additional relevant MeSH terms:
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Wound Infection
Surgical Wound Infection
Surgical Wound
Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes