Comparison of the Impact of Electric Scalpels Versus Cold Scalpels

NCT01410175 | Completed Phase 3

• 1 other identifier: SCALPEL 01
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection; Cicatrization

Outcome Measures

Primary Outcomes (1)

• Change in Surgical Incision Complications

  The following complications will be analyzed in those days: site infection, seroma, dehiscence, hematoma, bruise, hyperemia and quality of healing.

  15 and 30 days after surgery

Study Arms (2)

Conventional scalpel

EXPERIMENTAL

Use of conventional scalpel to incise the skin and subcutaneous layer.

Device: Conventional scalpel

Electric scalpel

NO INTERVENTION

Use of electric scalpel to incise the skin and subcutaneous layer.

Interventions

Conventional scalpel DEVICE

Use of conventional scalpel to incise the skin and subcutaneous layers.

Also known as: Cold scalpel

Conventional scalpel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• surgery with manipulation of the digestive system
• cases of re-operation

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784-400, Brazil

Location

Related Publications (1)

• Rongetti RL, Oliveira e Castro Pde T, Vieira RA, Serrano SV, Mengatto MF, Fregnani JH. Surgical site infection: an observer-blind, randomized trial comparing electrocautery and conventional scalpel. Int J Surg. 2014;12(7):681-7. doi: 10.1016/j.ijsu.2014.05.064. Epub 2014 May 24.

  PMID: 24866067 DERIVED

MeSH Terms

Conditions

Wound Infection; Cicatrix

Condition Hierarchy (Ancestors)

Infections; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Regiane L Rongetti

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: August 4, 2011
• Study Start: July 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2013
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

BR (1)