CLEARING THE PATH

Improving skin antisepsis is vital for both the patient undergoing the surgery and for the healthcare worker (HCW) performing the surgery. The prevention of nosocomial infections — especially that of surgical site infections (SSIs) — has been proven through the proper use of antiseptic agents.

Current agents used and available in the United States for skin antisepsis include isopropyl alcohol, povidone-iodine, chlorhexidine gluconate plus isopropyl alcohol, and chlorhexidine alone.¹ John S. Hibbard, PhD, a microbiologist, consultant, former clinical microbiology teacher, and president and chief executive officer of J&A Companies, LLC, states that combination antiseptics are best. “It is absolutely essential that the combination antiseptics contain two different antiseptics with two different mechanisms of killing action,” he asserts. “For example, if you use a quaternary ammonium salt (a quat) and use two different quats, they both have the same mechanism of action and therefore they will not have an additive effect on antisepsis. It’s an exercise in futility. The two antiseptics must have two different mechanisms of action to have an additive antiseptic effect and kill microorganisms more effectively. That is critical.”

Hibbard wrote a review article that includes four pivotal and two comparative clinical trials. The six clinical trials were conducted to determine which antiseptic is best for use as a patient preoperative skin preparation antiseptic. The objective of each of the studies were to compare the immediate and persistent (residual) and/or cumulative antimicrobial efficacy and safety of each of the following formulations as a preoperative skin antiseptic. Researchers investigated: 2 percent Chlorhexidine gluconate (CHG) plus 70 percent isopropyl alcohol (IPA); another 3 percent CHG plus 70 percent IPA antiseptic (CHG+IPA); a 2 percent aqueous CHG alone or 4 percent CHG alone; a 70 percent IPA alone or an iodine-containing solution; and a 10 percent povidone iodine (PVI).

Clinical Study No. 1: The 2 percent CHG plus 70 percent IPA demonstrated significantly better persistent (residual) antimicrobial activity than 70 percent IPA alone or 2 percent aqueous CHG alone. The 2 percent aqueous CHG alone did not meet the Food and Drug Administration’s (FDA) Tentative Final Monograph (TFM) requirements for a preoperative skin preparation product.

Clinical Study No. 2: The 2 percent CHG plus 70 percent IPA had significantly better immediate antimicrobial activity than 70 percent IPA alone or 2 percent CHG alone.

Clinical Study No. 3: CHG+IPA demonstrated significantly more persistent (residual) antimicrobial activity than 70 percent IPA alone. The 4 percent CHG did not meet the FDA TFM requirements for a preoperative skin preparation product.

Clinical Study No. 4: CHG+IPA and 70 percent IPA alone had significantly better immediate antimicrobial activity than 4 percent CHG alone. CHG+IPA had significantly better persistent (residual) antimicrobial activity than 70 percent IPA alone or 4 percent CHG alone. None of the antiseptics met the TFM requirements for a preoperative skin preparation for excessively large treatment areas on the groin.

Clinical Study No. 5: The 2 percent CHG plus 70 percent IPA demonstrated significantly better immediate antimicrobial activity as well significantly better persistent (residual) antimicrobial activity than 10 percent PVI alone. PVI alone did not meet the TFM requirements for a preoperative skin preparation.

Clinical Study No. 6: The 2 percent CHG plus 70 percent IPA provided equivalent immediate antimicrobial activity to 70 percent IPA alone but significantly better persistent and cumulative antimicrobial efficacy than 70 percent IPA alone.

Hibbard concluded from these clinical trials that 2 percent CHG plus 70 percent IPA and another CHG+IPA provided the best immediate, persistent (residual), and cumulative antimicrobial activity of all the antiseptics tested. This suggests the two combinations will potentially have “significant effects” in reducing SSIs and bacteremias — especially those associated with intravascular lines. “These results and the conclusions from the results were unmistakable,” he writes. “An antiseptic containing a combination of two antiseptics with different mechanisms for killing microorganisms consistently and significantly demonstrated better antimicrobial activity than any single antiseptic alone.”

Factors Influencing the Antimicrobial Activity of Antiseptics

Hibbard also points out that no matter the combination used, the amount will determine further its effectiveness.

“The other thing that we found, and this happened to us during our clinical trials, if you don’t apply enough antiseptic on the treatment area, and you try to treat too large an area with an inadequate amount of antiseptic, it just won’t work. No matter how good your antiseptic is, it doesn’t matter.”

Hibbard explains that there are at least six different variables involved in adequately covering a skin area with an antiseptic. They are:

1. The chemical identity of the active ingredient(s) (e.g., CHG+IPA, CHG, IPA, PVP-I).

2. The formula of the antiseptic which includes the concentration of the active ingredient(s).

3. The size of the treatment area.

4. The time the antiseptic is in contact with the skin (i.e., the application time).

5. The volume of antiseptic applied.

6. The manner in which the antiseptic is applied (e.g., firm scrubbing vs. gentle painting).

“You have to take all of those variables into consideration,” he warns, “but perhaps the two most important variables are the amount or quantity of antiseptic used and the area of skin you are treating.

“There are some areas of the body that are harder to treat with antiseptics than other areas of the body. If you’re doing open heart surgery, it is a large area of the skin. Fortunately the chest is not near as difficult to treat as the groin. The two hardest areas to treat are the groin area (and we have had antiseptics fail in that area) and the axillary area [the armpit].”

He explains that the key to successful antisepsis is using enough antiseptic while rubbing a specified area for at least two minutes with a combination antiseptic. “The chest area and the abdomen are not near as hard to treat as the groin,” he continues.

“So you can treat a larger area with an antiseptic and not rub near as long or hard (for example, you can rub for one minute). You can get rid of almost all, but not all, of the microorganisms on the skin. So it has to do with the area of the body and the variables involved in the application of the antiseptic.”

Another hard-to-treat area is the axillary area, he says. “Both the groin and the armpit are loaded with sebaceous and sweat glands with very rough skin and hard-to-reach microorganisms. Those are the areas where you sweat the most and that’s where you have the most trouble killing microorganisms.”

Microorganism Immobilization

As Hibbard points out, the majority of infections after surgery are due to the patient’s own microorganisms. “We could do a lot better preventing infections,” he says. “If you look at the number of different microorganisms that alcohol kills and the combination antiseptic products kill, it is very impressive — and this includes bacteria, viruses and fungi. If we consistently used products that had persistent activity to protect us from germs ... I think we could do a lot better at preventing infections.” We may not be far off from such products and their consistent usage as Hibbard mentions, but in the meantime, Kimberly-Clark Health Care’s recent launch of an interesting aid in the microorganism fight so far provides promise.

“We know from the research that most SSIs are caused by pathogens from the patient’s own endogenous flora,” shares John Amat, vice president of Kimberly-Clark Health Care. “These pathogens can enter the surgical incision by way of irrigation fluids, gloves, instruments, sponges or implants. And while skin can never be sterile, the healthcare community has recognized the importance of minimizing the opportunity for bacteria to find its way into the incision.”

Kimberly-Clark’s latest product, InteguSeal® Microbial Sealant, is designed with this effort in mind. It seals and immobilizes the bacteria on the skin to protect the incision from contamination.

InteguSeal is a film-forming, cyanoacrylatebased microbial sealant that is painted onto the skin after the preoperative skin preparation had been performed and prior to making the surgical incision. Its mechanical action seals down the skin and protects the incision from pathogens residing deep in the skin and those surviving the preoperative preparation.

“The skin remains breathable and it is not an antimicrobial so it won’t promote bacterial resistance, which is such a huge issue in healthcare today,” Amat adds. Also, InteguSeal can be used in a wide variety of surgeries. It’s appropriate for clean and clean-contaminated cases where skin flora is the major cause of infection.

The device is available in two applicator sizes to accommodate different coverage requirements. The slimmer IS100 is used in surgeries with small-to-medium surgical sites, such as hernia repairs or cardiac catheterizations, and covers an area up to 10 inches by 10 inches. The larger IS200 is suggested for use of the larger surgical sites, such as open heart or total joint replacements. This size applicator covers up to 20 inches by 10 inches.

InteguSeal remains on the skin throughout surgery and up to five to seven days following surgery. It protects the prep from washing off around the incision site and naturally wears away as the skin exfoliates. It doesn’t need to be removed for closure and is compatible with sutures, staples, and wound adhesives. InteguSeal should not be used on or around the eyes and areas involving mucous membranes, and can be removed thoroughly with soapy water, mineral oil or acetone.

“It should be stressed that InteguSeal is a microbial sealant and not a skin prep,” Amat stresses. “This microbial barrier marks the start of a new category by taking SSI prevention one step further.”

InteguSeal has been used in more than 8,500 applications during surgery internationally. In November 2006, InteguSeal was cleared by the FDA for sale in the United States.

As far as skin antisepsis for the operating room (OR) staff, Hibbard says several effective options exist. “Fortunately, there are excellent substances that they can use to scrub their hands before surgery (a surgical scrub). One of the best, cheapest, and easiest to use is alcohol.

It is an extremely effective antiseptic. If I were in charge of an operating room, I would go easier on the soaps — the antibacterial soaps — and I would go more towards the use of alcohol rubs and the alcohol dips.”

He explains that the alcohols are commonly used in Europe, at a much higher rate than they are used here. “I think they are ahead of us, quite frankly. I believe the future is moving toward the alcohol rubs and dips. Ethanol is good; isopropanol is probably a little bit better, and n-propanol is probably the best of all the alcohols to use, but for some reason we do not use n-propanol in this country. It is used in Europe a lot, and it is a more effective germ killer at lower concentrations. Alcohols are very effective. A 70 percent alcohol is extremely effective — it just doesn’t last as long as combination product antiseptics like (the 2 percent CHG plus 70 percent IPA and the CHG+IPA).

“If there was a substance on the market that would be like a combination product like (the 2 percent CHG plus 70 percent IPA or the CHG+IPA) for a surgical scrub, I would strongly urge the use of that product. I am not aware of a combination product that’s on the market right now that’s been approved for surgical scrub. There might be, I haven’t looked at it now for a year or two.”

Hibbard offers that the overall, lasting deterrent to SSIs and other adverse surgical outcomes will always boil down to surgical consciousness and upholding stellar aseptic technique practices.

“I taught medical students antiseptic techniques and microbiology for many years. What we need to get back to, and I think we are starting to get back to it, is a greater understanding of aseptic techniques in the operating room and part of this aseptic technique is the use of a really good antiseptic before we start operating on someone. There is a whole host of things that we need to do in order to prevent infections, and of course preventing infections is the key to the whole thing.

“The other part of this problem is the inability of the medical community to change from the use of a single antibiotic for initial treatment of infections to the use of a combination product — like we’ve recently started doing with the use of combination antiseptics. The two antibiotics must have different mechanisms of action. They have to kill the microorganisms two different ways or the antibiotic effect won’t be additive.” 

Reference

1. Hibbard, JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005. May-Jun;28(3):194-207.


CASE STUDY

Labor and Delivery Department Lowers C-Section Surgical Site Infection Rates with 2 Percent CHG Cloths

BROOKDALE UNIVERSITY MEDICAL CENTER
Brooklyn, NY

Robert Garcia, BS, MT, CIC, the assistant director of infection control at Brookdale University Medical Center in Brooklyn, N.Y., was a key player in an initiative implemented eight months ago to drive down rates of Caesarean section (C-section) surgical site infections (SSIs).

During a review of current practices and protocols for antiseptic preparation of surgical patients, Garcia says what he and his colleagues found was surprising. “To be honest, we didn’t have a set protocol for that area,” he shares. With no real policy in place for the labor and delivery patients, Garcia set out to investigate what improvements could be made.

“When I investigated what they were doing, I found out the hospital was purchasing a custom pack for patients undergoing C-sections,” he explains. “When I obtained one of those and opened up the pack, I found large packets of povidone iodine (PVI) in swab form. We also found there were no real directions on the packages themselves. If the manufacturer does not provide detailed instructions on how to use the product, then obviously the staff is really going to have no idea and more than likely there is no standard among the staff on what to do. So no policy and no set instructions was really a poor combination,” he says.

Garcia set out to mold an action plan: a multi-step procedure for essentially decolonizing the skin of the patients coming into the labor and delivery department. “The patient undergoing a C-section is actually fairly unique because when they (present to) the labor and delivery area, it is not often that you already have a concrete idea that they will undergo a C-section,” Garcia explains.

Garcia needed a simplistic, inexpensive plan for protecting this patient group; something that would virtually offer a foresight into each woman’s outcome. His answer was a simple wipe-down of the skin with a 2 percent chlorhexidine gluconate (CHG) impregnated cloth.

“The prime cause of SSIs are the bacteria found on the patient’s skin,” he points out. “We can certainly make greater efforts to reduce as much of the bacteria on the patient’s skin as possible. For those females entering labor and delivery, they have an initial step that uses a new product on the market that has been approved for patients undergoing surgical procedures. It was actually in a very convenient form for the staff to use.

“The new protocol states that any patient presenting to labor and delivery is to have a treatment, a scrub procedure let’s say, in the area where a C-section incision would be performed.” This would continue every six hours throughout the patient’s labor. Then, for the patients in which a c-section is deemed necessary, the revised C-section packs had a combination surgical antiseptic product (70 percent alcohol and 2 percent CHG) to further decolonize the patient’s skin for surgery. “The decision-makers in labor and delivery came to the conclusion that there was significant information in the literature — so the practice is all evidence-based — that CHG was the best antiseptic on the market, and second, there was very good information that CHG was much more effective when used in a repeated fashion.

“CHG has tremendous residual activity. Its effects on killing bacteria last for a considerable amount of time. The repeated use of CHG, we felt, significantly contributes to reducing the bacterial load on the patient, therefore directly reducing the risks of the patient developing a surgical site infection.”

In the eight months since the labor and delivery department initiative, Garcia says they have seen a 20 percent reduction of complications among C-section patients. He states that they are still investigating and recording the outcomes and discerning and pinpointing the exact causation of improvement, but “it should be noted that we have not had any other major changes among surgical patients. This is the only one major thing that has been revised.”

Brookdale University Medical Center is now considering rolling the program out to the medical center’s ambulatory surgical centers. In this format, during the preoperative visit, the patient will receive a written protocol for using the 2 percent CHG cloths. They will be instructed to apply to product after their shower the night before the procedure and apply again on the morning of the procedure.

“Antiseptics work when they are applied to the skin and left on the skin,” Garcia explains. “They should not be washed off or rinsed off.”


CASE STUDY

Applying Evidence-Based Practice to Protect Surgical Patients

ST. LUKE HOSPITALS — ST. LUKE EAST AND ST. LUKE WEST
Ft. Thomas and Florence, Kentucky

Ginny Lipke, RN, BS, CIC, manager of infection control for the St. Luke Hospitals had been reading up on recent published articles on chlorhexidine gluconate (CHG); namely that of Robert Weinstein MD and his colleagues’ article published in the February 2006 issue of the Archives of Internal Medicine.¹ As participants in the Chicago Antimicrobial Resistance Project (CARP), the department of medicine at Stroger (Cook County) Hospital, in Chicago, performed a prospective, single-arm clinical trial in the hospital’s medical intensive care unit (ICU) from October 2002 through December 2003. Weinstein and his colleagues set out to investigate if CHG-impregnated cloths would reduce the load of vancomycinresistant enterococci (VRE) found in the medical ICU.

All patients in the medical ICU were cleansed daily with the procedure specific to the study period. The study periods were as follows:

Period 1: soap and water baths

Period 2: cleansing with cloths saturated with 2 percent CHG

Period 3: cloth cleansing without chlorhexidine

The researchers then measured the colonization of patient skin, healthcare worker (HCW) hands and environmental surface contamination by VRE.

The results showed the CHG-saturated cloths to be a “simple, effective strategy to reduce VRE contamination of patients’ skin, the environment, and healthcare workers’ hands,” the researchers concluded. More importantly, there was a marked decrease in patient acquisition of VRE, with the incidence of VRE acquisition decreasing from 26 colonizations per 1,000 patient days to nine per 1,000 patient-days.

Lipke says she was quite impressed by the findings of this and other studies concerning CHG, so when she was subsequently approached by Sage Products to conduct a study on selected surgical patients using its 2 percent CHG cloths vs. a 4 percent CHG prewash used in the shower, it was no surprise she jumped at the chance. “Currently we are doing the study on bariatric patients,” Lipke explains. “We have a wonderful bariatric surgeon who said that he would love to take part in the study and thought it was a great idea.”

The study began enrolling patients in March 2006 and is still underway. The patients are randomized in each arm of the study, and the results so far are “pretty intriguing,” according to Lipke.

“There is so much data out there already that CHG is a powerful agent and not only does a wonderful job at cleansing the skin, but it is also a pretty powerful broad spectrum antimicrobial. It really demonstrates effectiveness against gram positives, has good effectiveness against the gram negative bacterias, and against viruses.

“For our purposes, helping to reduce the microorganisms that are on a patient’s skin prior to surgery, it is ideal because of its persistence. The CHG has persistence activity up to, I believe, six hours.”

She continues, “We wanted something easy to use. Some patients are getting up at five or six in the morning in order to make it to their procedure. For some patients this is a lot to do, especially for our more infirmed patients. Getting in and out of the shower can become more of a risk factor and can become dangerous for them. We wanted something that would be effective, but at the same time would be easy and convenient to use because then hopefully the patient would remember to use it.”

Lipke is spinning the CHG usage into a broader study involving surgical patients. This multi-faceted approach will be Lipke’s and St. Luke’s cumulative fight against infection.

A sister hospital in Cincinnati recently published a study on the use of mupirocin reducing the rate of deep sternal wound infections in cardiac surgical patients and Mary Nicholson, the head researcher of this study, came to Lipke’s facility to educate the St. Luke staff on the practice.

“I found it very intriguing,” Lipke says. “You’re doing active surveillance, you’re using the mupirocin ... then I thought, ‘I wonder what would happen if you tacked on the use of the CHG body wash to decolonize the entire body?’ “If the patient’s own flora is contributing to (a high percentage) of SSIs, then how are we best controlling this to give the patient the optimum outcome? Dr. Peterson’s paper represents the benefit to reduce the bioburden on the patient’s skin.”

St. Luke will be rolling out a methicillin resistant Staphylococcus aureus (MRSA) bundle in 2007, and the education for the bundle began the first week of February. “Mary’s (Nicholson) PowerPoint presentation of her study really showed us that we need to be doing active surveillance for MRSA,” Lipke explains.

“People who are colonized with MRSA are at a 10-fold increase for infection later on. And if that’s truly the case, then it really behooves us to do everything that we can to not have that MRSA infection occur. We think the mupirocin is a good avenue and reduction of the bioburden on the patient’s skin will really help to put all the cards in the patient’s favor. It’s really all about the patient; it’s all about their outcome.

Lipke’s facility will not only be offering this bundle to its surgical patients, but Lipke says she has “a very large OB group on our campus and they want to take part in this also.”

“They will be doing the nasal surveillance swabs at the week 36 visit; and when the patient presents for a C-section, she will be bathed by a labor and delivery nurse with the 2 percent CHG wipes. We also just received the approval to do active surveillance cultures in our preadmission area. We will be giving our patients the 2 percent CHG clothes. Then, we will start looking at our data to see if we can see a discernable drop in our infection rates.”

Lipke also recently put in a request to extend the current study of the 2 percent vs. 4 percent CHG products.

To clarify, Lipke points out that her facilities both boast impressively low rates of infection, “But the push is to go to zero,” she explains. “It’s very exciting that we have a department of surgery that is open and forward-thinking. So is our hospital administration. They are always looking at ‘What can we do now to help the patient and improve quality?’ So, I am just thrilled about this program. I can’t wait to get everyone involved, educated, and ready to roll this out and start collecting data. I think we really have a good chance of making a positive impact with this.”

Reference

1. Vernon MO, et. al. Chlorhexidine gluconate to cleanse patients in a medical intensive care unit: the effectiveness of source control to reduce the bioburden of vancomycin-resistant enterococci. Arch Intern Med. 2006 Feb 13;166(3):306-12.

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