Comparison of the Impact of Electric Scalpels Versus Cold Scalpels (SCL01)
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.
|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."|
- 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.
|Study Start Date:||July 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01410175
|Barretos Cancer Hospital|
|Barretos, SP, Brazil, 14784-400|
|Principal Investigator:||Regiane L Rongetti||Barretos Cancer Hospital|