Comparison of the Impact of Electric Scalpels Versus Cold Scalpels

Wound Infection Clinical Trial

— SCL01  

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."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410175
• Other study ID #: SCALPEL 01
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2011
• Last updated: May 22, 2014
• Start date: July 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2014
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

Introduction Surgical site infection (SSI) is the second commonest hospital infection, despite advances in prevention that have been achieved. However, among surgical patients, it is the hospital infection of greatest incidence. In the United States, it has been estimated that around 500,000 cases of SSI occur every year, thus generating an annual cost of more than 1.6 billion dollars.

According to the Centers for Disease Control (CDC), SSI can appear up to 30 days after performing the surgical procedure and up to one year afterwards, when a prosthesis was implanted. SSI is classified as superficial infection when it only affects the skin and subcutaneous tissue at the incision site. It is classified as deep infection when it involves deep structures of the wall and muscle layers of organs and spaces in any part of the anatomy that is opened or manipulated during the surgical procedure, with the exception of the incision.

SSI has a series of consequences. These include increased duration of hospitalization, increased cost of medical and hospital care, increased prescription of broad-spectrum antibiotics (with consequent increased bacterial resistance) and increased postoperative mortality, given that 30% to 40% of deaths during this period result from this type of infection.

The risk factors most frequently correlated with SSI are in connection with the patient and the surgical procedure and include obesity, malnutrition, smoking, age extremes, diabetes, chronic obstructive pulmonary disease, immunosuppression, alcoholism, use of corticoids, potential for contamination of the operative wound, long-duration operations, presence of a foreign body at the surgical site, incorrect administration of antibiotic prophylaxis and poor surgical technique. Thus, the risk of SSI may vary according to the type of surgery and each individual's inherent conditions.

With regard to surgical technique, the points that need to be taken into consideration include careful dissection and manipulation of the tissue so as to minimize the tissue trauma, adequacy of hemostasis to impede formation of hematomas, avoidance of environments favorable to microbe proliferation and excessive use of electric scalpels or their use with higher-than recommended currents, which has a high potential for tissue devitalization. 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.

Methodology:

This is a blinded randomized clinical trial composed of two groups (cold scalpel versus electric scalpel), among patients undergoing elective abdominal gynecological surgery at Barretos Cancer Hospital between July 2010 and July 2012. These patients will fulfill the following inclusion criteria: over 18 years of age, agreement to participate in the study and undergoing elective abdominal gynecological surgery for the purposes of diagnosis or curative or palliative oncological treatment. The following types of patient will be excluded: patients undergoing surgery with manipulation of the digestive system, patients undergoing surgery to open a stoma and cases of reoperation. The randomization will be performed at the time of the surgery by the Research Support Center of Barretos Cancer Hospital, with further subdivision of the patients into two groups, with body mass index (BMI) < 30 and ≥ 30. The cold scalpel and electric scalpel will be used in accordance with the randomization, to open the skin and the subcutaneous cellular tissue. The aponeurosis and peritoneum will be incised using an electric scalpel. The data will be gathered by the investigator, who will make direct observations of the operative wound in order to make diagnoses of SSI after discharge from hospital, with assessments on the 14th and 30th days after the operation. The present project has been approved by the Research Ethics Committee of Barretos Cancer Hospital. Subjects who agree to participate will show their acceptance through signing a free and informed consent statement. Other factors such as hematoma, seroma, bulging, etc., will also be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: January 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrization
• Wound Infection

Intervention

Device:
• Conventional scalpel
Use of conventional scalpel to incise the skin and subcutaneous layers.

Locations

Country	Name	City	State
Brazil	Barretos Cancer Hospital	Barretos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No