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The Efficacy of Pre - Disinfection Skin Scrub With 4% Chlorhexidine Gluconate in Preventing Surgical Site Infections for Patients With Hepatectomy


Phase 4
18 Years
92 Years
Not Enrolling
Both
Liver Tumors

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Trial Information

The Efficacy of Pre - Disinfection Skin Scrub With 4% Chlorhexidine Gluconate in Preventing Surgical Site Infections for Patients With Hepatectomy


Surgical site infections (SSIs) following elective surgical procedures occur most commonly
as a result of colonization by the patient's native skin flora . The most common pathogens
causing SSIs are Staphylococcus aureus and coagulase-negative Staphylococci , components of
normal skin flora . Therefore, preoperative disinfection of the surgical site with an
antiseptic skin preparation is standard practice before any surgical intervention to
decrease skin microbial counts before incision . It is considered an important step in
limiting surgical wound contamination and preventing infection.

A variety of skin-preparation agents and methods are available for preventing surgical site
infections and the techniques for preoperative cleansing of the skin vary among hospitals
and surgeons. There is a pressing need to elucidate the effect of cutaneous disinfection
with chlorhexidine gluconate ( CHG ) in prevention of surgical site infections.

Many studies demonstrated that comparisons with cutaneous disinfection with povidone-iodine,
disinfection with CHG before insertion of an intravascular device and for post-infection
site care can substantially reduce the incidence of device-related infection .

Hence, this study aimed to test whether an additional chlorhexidine gluconate scrub followed
by a routine disinfection would lower the incidence of surgical site culture and subsequent
infection after hepatic resection. This data will show the originality and clinical
importance of a cutaneous pre-disinfection scrubbing solution for such risk patients with
hepatectomy.


Inclusion Criteria:



- patient who received elective hepatectomy for liver tumors

Exclusion Criteria:

- patients who were younger than 18 years of age

- patients who had a history of radiation to the operative sites

- patients who received repeat hepatectomy

- patients who had a history of allergy to CHG, ethyl alcohol or povidone - iodine

- patients whose tumors were metastatic cancers

- patients who had a preoperative active remote infection

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

the positive rate of the baseline culture , the preoperative culture , and the postoperative culture

Outcome Description:

Before surgical preparation while the patient was on the table in the operating room , we obtained the first set of aerobic culture from the predefined incision site as the baseline culture. After skin scrubbing and disinfection , we obtained the second set of aerobic culture from the predefined incision site as the preoperative culture. After closure of the wound , we obtained the third set of aerobic culture from the surgical site as the postoperative culture. The result of culture was positive if bacteria were cultured from either stage of the surgical site sampling. We compared the efficacy for eradicating aerobic bacterial pathogens ( reduction of positive culture )from the abdomen between the chlorhexidine gluconate scrubbing group and normal saline scrubbing group .

Outcome Time Frame:

within 30 days after the operation

Safety Issue:

Yes

Principal Investigator

YaoLi Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Changhua Christian Hospital

Authority:

Taiwan: Department of Health

Study ID:

CCH - 110801

NCT ID:

NCT01782573

Start Date:

October 2011

Completion Date:

September 2012

Related Keywords:

  • Liver Tumors
  • pre - disinfection scrubbing solution
  • surgical site culture
  • surgical site infection
  • liver tumors
  • hepatectomy
  • chlorhexidine gluconate
  • Liver Neoplasms

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