ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01410175
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital

Brief Summary:

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.

Objectives:

  • 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 or disease Intervention/treatment Phase
Wound Infection Cicatrization Device: Conventional scalpel Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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."
Study Start Date : July 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : January 2013

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in Surgical Incision Complications [ Time Frame: 15 and 30 days after surgery ]
    The following complications will be analyzed in those days: site infection, seroma, dehiscence, hematoma, bruise, hyperemia and quality of healing.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01410175


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT01410175     History of Changes
Other Study ID Numbers: SCALPEL 01
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Infection
Wound Infection
Cicatrix
Fibrosis
Pathologic Processes