NCT02332252

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 4, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

January 4, 2015

Last Update Submit

January 2, 2018

Conditions

Surgical Wound Infection

Keywords

Surgical Wound InfectionElectrocauteryScalpel

Outcome Measures

Primary Outcomes (1)

  • Surgical Site Infection

    Presence of signs of surgical site infection after cesarean section.

    8 days

Secondary Outcomes (1)

  • Post operative pain

    8 days

Study Arms (2)

Scalpel

ACTIVE COMPARATOR

Skin incision performed with a scalpel during cesarean section.

Device: ScalpelProcedure: Skin incision

Electrocautery

EXPERIMENTAL

Skin incision performed with an electrocautery during cesarean section.

Device: ElectrocauteryProcedure: Skin incision

Interventions

ScalpelDEVICE

Skin incision performed with a scalpel during cesarean section.

Scalpel
ElectrocauteryDEVICE

Skin incision performed with an electrocautery during cesarean section.

Electrocautery
Skin incisionPROCEDURE
ElectrocauteryScalpel

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Elective Cesarean section, regardless of gestational age.

You may not qualify if:

  • Skin infection in the cesarean section area.
  • Emergency cesarean section.
  • Presence of a maternal pathology that increases the risk of infection (immunocompromised state).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas H

Panama City, Panama

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Laser TherapyElectrocoagulation

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, OperativeCautery

Study Officials

  • Osvaldo Reyes, MD

    Saint Thomas Hospital, Panama

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of research

Study Record Dates

First Submitted

January 4, 2015

First Posted

January 6, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

August 1, 2016

Last Updated

January 4, 2018

Record last verified: 2018-01

Locations

PA(1)