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Comparison of the Impact of Electric Scalpels Versus Cold Scalpels (SCL01)

This study has been completed.
Information provided by (Responsible Party):
Barretos Cancer Hospital Identifier:
First received: June 21, 2011
Last updated: May 22, 2014
Last verified: May 2014

Surgical site infection (SSI) is the second commonest hospital infection, despite advances in prevention that have been achieved.

According to Fernàndes, experimental studies have demonstrated that incorrect use of electric scalpels may double the rate of SSI during electrocauterization.

Because of the lack of solid data in the literature, in relation to the impact on SSI of using electric scalpels for making incisions in the skin and all subcutaneous tissues, it was judged to be opportune to conduct the present study.


  • To compare the incidence of SSI and other complications of the operative wound among patients undergoing elective abdominal gynecological surgery at Barretos Cancer Hospital, between the use of electric and cold scalpels.
  • To identify the incidence of SSI and other complications of the operative wound among patients undergoing elective abdominal gynecological surgery, when using electric scalpels for skin incisions and for subcutaneous incisions.
  • To identify the main risk factors for SSI among patients undergoing elective abdominal gynecological surgery.

Condition Intervention Phase
Wound Infection
Device: Conventional scalpel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: "Impact on the Incidence of Surgical Site Infection in Abdominal Gynecological Surgery by Comparing the Skin and Subcutaneous Tissue Incision With Cold Scalpel and Electrocautery in a Period of Two Years."

Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:
  • Change in Surgical Incision Complications [ Time Frame: 15 and 30 days after surgery ] [ Designated as safety issue: No ]
    The following complications will be analyzed in those days: site infection, seroma, dehiscence, hematoma, bruise, hyperemia and quality of healing.

Enrollment: 163
Study Start Date: July 2010
Study Completion Date: January 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional scalpel
Use of conventional scalpel to incise the skin and subcutaneous layer.
Device: Conventional scalpel
Use of conventional scalpel to incise the skin and subcutaneous layers.
Other Name: Cold scalpel
No Intervention: Electric scalpel
Use of electric scalpel to incise the skin and subcutaneous layer.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age => 18 yo
  • elective abdominal gynecological surgery for the purposes of diagnosis or curative or palliative oncological treatment

Exclusion Criteria:

  • surgery with manipulation of the digestive system
  • cases of re-operation
  Contacts and Locations
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Please refer to this study by its identifier: NCT01410175

Barretos Cancer Hospital
Barretos, SP, Brazil, 14784-400
Sponsors and Collaborators
Barretos Cancer Hospital
Principal Investigator: Regiane L Rongetti Barretos Cancer Hospital
  More Information

No publications provided by Barretos Cancer Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Barretos Cancer Hospital Identifier: NCT01410175     History of Changes
Other Study ID Numbers: SCALPEL 01
Study First Received: June 21, 2011
Last Updated: May 22, 2014
Health Authority: Brazil: National Committee of Ethics in Research processed this record on March 03, 2015