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Clinical Trials/NCT01410175
NCT01410175CompletedPhase 3

"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."

Barretos Cancer Hospital2 sites in 1 country163 target enrollmentStarted: July 1, 2010Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
163
Locations
2
Primary Endpoint
Change in Surgical Incision Complications

Study Overview

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in Surgical Incision Complications

Time Frame: 15 and 30 days after surgery

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Barretos Cancer Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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