Electrocautery Versus Scalpel for Surgical Skin Incisions... | NCT02332252

Studies
Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.

NCT02332252

Sponsor

Saint Thomas Hospital, Panama

Status

Completed

Last Update Posted

Jan 4, 2018Actual

Enrollment

500Actual

Phase

Not Applicable

Conditions

Surgical Wound Infection

Interventions

Scalpel
Electrocautery
Skin incision

Countries

Panama

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jan 4, 2015

First Submission Date that Met QC Criteria

Jan 5, 2015

First Posted Date

Jan 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2018

Last Update Posted Date

Jan 4, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Osvaldo A. Reyes T., Coordinator of research, Saint Thomas Hospital, PanamaPrincipal Investigator

Lead Sponsor

Saint Thomas Hospital, PanamaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Scalpel	Active Comparator	Skin incision performed with a scalpel during cesarean section.	Device: Scalpel Procedure: Skin incision
Electrocautery	Experimental	Skin incision performed with an electrocautery during cesarean section.	Device: Electrocautery Procedure: Skin incision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Scalpel	Device	Skin incision performed with a scalpel during cesarean section.	Scalpel

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Osvaldo Reyes, MD	Saint Thomas Hospital, Panama	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Thomas H		Panama City			Panama

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy
D004564	Electrocoagulation

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative
D002425	Cautery

Browse Leaves

Not provided

Browse Branches

Not provided