Comparison of the Impact of Electric Scalpels Versus Cold Scalpels (SCL01)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Barretos Cancer Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Barretos Cancer Hospital
Information provided by:
Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01410175
First received: June 21, 2011
Last updated: August 3, 2011
Last verified: May 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Wound Infection Cicatrization |
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." |
Resource links provided by NLM:
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.
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated 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 Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410175
Locations
| Brazil | |
| Barretos Cancer Hospital | Recruiting |
| Barretos, SP, Brazil, 14784-400 | |
| Contact: Regiane L Rongetti +55 17 3321 6600 ext 6836 ccih@hcancerbarretos.com.br | |
| Principal Investigator: Regiane L Rongetti | |
| Sub-Investigator: José H Fregnani | |
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
| Principal Investigator: | Regiane L Rongetti | Barretos Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Regiane Ladislau Rongetti, Barretos Cancer Hospital |
| ClinicalTrials.gov Identifier: | NCT01410175 History of Changes |
| Other Study ID Numbers: | SCALPEL 01 |
| Study First Received: | June 21, 2011 |
| Last Updated: | August 3, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Additional relevant MeSH terms:
|
Cicatrix Wound Infection Fibrosis |
Pathologic Processes Infection Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013