Trial Information

"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."

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.