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By Judith A. Brumm, RN, CNOR and Shirley J. Taylor, RN, BSN, CNOR, CRCST
The patient’s skin is a potential source for surgical site infections (SSIs). The purpose of surgical skin preparation is to reduce the number of microorganisms on the skin’s surface. This is accomplished by removing dirt and oil without causing damage to the skin’s natural protective function or interfering with postoperative wound healing. Skin is the largest organ of our body and the first line of defense against infection. One source of contamination is endogenous so we must clean the area to prevent bacteria on the skin from entering the incision site. Proper surgical patient skin preparation is one step in preventing SSIs.
The skin has two main layers, the epidermis and the dermis. The epidermis is the superficial, outer, non-vascular layer of skin that is a protective barrier. It is composed of epithelial cells and dead keratinized cells that are worn away but the dermis replaces these cells. The dermis is the deeper part between the epidermis and subcutaneous tissue. It is composed of connective tissue containing blood and lymphatic vessels, nerves, sweat and sebaceous glands.1
Both skin levels have bacterial flora, which are transient or resident bacteria. Transient bacteria are found on the epidermis and are a noncolonizing flora. Resident bacteria stick to the cells of the dermis and are a colonizing flora.2 A common carrier for SSIs is the patient’s skin flora.3
Historically, nosocomial infections have represented major sources of morbidity and mortality for hospitalized patients. According to the Centers for Disease Control and Prevention (CDC) Guideline for Prevention of SSI, 1999, SSIs add 7.3 post-operative hospitalization days to a patient’s stay and $3,152 in additional costs; they account for nearly 14 to 16 percent of all nosocomial infections with an estimated 500,000 per year; they are the third most frequently reported nosocomial infection and the most expensive; they are the most common nosocomial infection, accounting for 38 percent, and of surgical patients with nosocomial SSIs who die, 77 percent of the deaths are from the infection.4
There are risk factors that put a patient in a higher category to develop a SSI. These could be procedure or patient related. Any of these risks could be a contributing factor for a patient to develop a SSI. If these risk factors are known before surgery prevention measures or actions should be utilized.5
The key to decreasing the potential of SSIs is prevention. To decrease healthcare SSIs, the CDC provides us with prevention recommendations in its 1999 Guideline. Also, the Hospital Infection Control Practices Advisory Committee (HICPAC) endorses these guidelines. The guidelines have rankings labeled as categories. Categories IA and 1B are applicable and should be adopted by healthcare facilities at various levels.6
Other important prevention recommendations would include the patient preoperative antiseptic shower and the use of a Food and Drug Administration (FDA) approved antiseptic. The CDC’s 1999 guideline states that patients are required to bathe or shower using an antiseptic agent on at least the night before the operative procedure. This shower or bath reduces the bacterial colony count, but it has not shown to decrease the rate of SSIs.7 Gruendemann and Mangum showed statistics from a study of some 700 patients who showered twice with antiseptics preoperatively. The microbial colony count was reduced 9-fold using chlorhexidene, 1.3-fold using povidone-iodine and 1.9-fold using triclocarban-medicated soap. The shower or bath is considered a CDC Category IB recommendation.8
The antiseptic used for bathing should be approved using the testing criteria from the FDA’s Tentative Final Monograph (TFM) for Antiseptic Drug Products for preoperative skin preparation. The goal for this recommendation would be to reduce the number of bacterial flora at the patient’s incision site.9
Preoperative Skin Care
The CDC’s 1999 guideline states that the incision site should be clean before surgical skin preparation and has labeled this a Category IB.10 In the Standards, Recommended Practices, and Guidelines of the Association of periOperative Registered Nurses (AORN) it states, “The surgical site and surrounding areas should be clean.”11
The CDC’s 1999 guideline recommends that hair not be removed unless it interferes with the surgical procedure and is a Category IA recommendation.12 Also, according to AORN standards, “Whenever possible, hair should be left at the surgical site.”13 Hair-removal methods discussed are depilatory; dry clipped using an electric clipper and wet using a disposable razor.
The depilatory method is a cream applied to the skin. This cream can cause skin irritation and/or hypersensitivity. A skin sensitivity test is required before application on the entire area. The dry, clipped method uses an electric clipper. In the CDC’s 1999 guideline it states, “Clipping hair immediately before an operation also has been associated with a lower risk of SSI than shaving or clipping the night before an operation.”14 The wet removal uses a disposable razor and soapy lather. The CDC’s 1999 guideline also states, “The increased SSI risk associated with shaving has been attributed to microscopic cuts in the skin that later serve as foci for bacterial multiplication.”15
The time between the shave and the incision is vitally important. Immediately before the incision is an ideal time for hair removal, which is a CDC Category IA recommendation.16 The more time elapsed between the shave and the incision the greater potential for wound infection. One study reported in Infection Control and Hospital Epidemiology states, SSI rates were 5.6 percent using a razor compared to 0.6 percent using a depilatory, 3.1 percent shaving immediately before incision compared to 7.1 percent within 24 hours preoperatively and 1.8 percent clipping immediately before incision compared to 4.0 percent within 24 hours preoperatively. If shaving was performed more than 24 hours preoperatively, the SSI rate exceeded 20 percent. 17
The FDA regulates antiseptic products. In its 1994 TFM, the FDA classified the products into three headings labeled patient preoperative skin preparation, antiseptic hand-wash or healthcare worker handwash and surgical hand scrub.18 The FDA set up criteria for testing the activity properties of these agents. This criterion includes reaction time, persistence activity and residual activity against certain organisms that are tested using both in vitro and in vivo studies.
Before being marketed, antiseptics must meet the FDA’s specifications found in their 1994 monograph. Pournoor states that according to the FDA for surgical skin preparations to be effective the bacterial contamination levels must be reduced by two to three logs.19
Also, in this monograph the antiseptics are classified into categories according to safety and effectiveness.20 CDC’s 1999 guideline states that an antiseptic be used for skin preparation.21 AORN standards state, “When indicated, the surgical site and surrounding area should be prepared with an antiseptic agent.”22
For selection of antiseptic agents in healthcare institutions it is recommended to use data provided by scientific literature, manufacturers’ tests and the FDA’s categories for selection of agents. Each antiseptic agent possesses different attributes. Antiseptic selection begins by deciding the specific attributes needed followed by studying the reduction of the bacterial count. Final product decision would also take into account the cost and acceptance by personnel.23 According to AORN standards, “Products and medical device evaluations should be based on objective criteria specific to the product’s or medical device’s function and use.”24
The antiseptics discussed are Iodophor, Para-chloro-meta-xylenol (PCMX), Chlorhexidine Gluconate (CHG), alcohol and Triclosan. Discussion will include action mode, reaction time, persistence, activity spectrum, and safety.
Iodophors penetrate the cell wall with oxidation of the contents and free iodine substitution. There is a fast reaction time and intermediate persistence. Iodophors rapidly neutralize in the presence of organic matter. It has excellent activity against Gram-positive organisms and good activity against Gram-negative and TB organisms, fungi and viruses. It is a skin irritant and can be absorbed through the skin. Iodophors contain both iodine and a carrier. This combination provides a reservoir for the iodine. This reservoir determines the iodine available while the amount of iodine in solution indicates the free iodine. The activity of iodophors is dependent on the concentration of this free iodine.
The FDA TFM has tentatively classified iodophors in 5 to 10 percent concentration as Category I, a safe and effective agent.
PCMX disrupts the cell wall, inactivating the enzymes. Both the reaction time and persistence is intermediate. It has good effect against Grampositive organisms with fair effect against Gram-negative, fungi, viruses and Mycobacterium tuberculosis (TB) organisms. PCMX is minimally effective in the presence of organic matter. It can penetrate the skin and is neutralized by nonionic surfactants.
The FDA TFM has classified PCMX as a Category IIISE. The data is insufficient to classify it as safe and effective. The FDA continues to evaluate PCMX.
CHG disrupts the cell wall with precipitation of the contents. The reaction time is intermediate while the persistence is excellent. CHG has excellent activity against gram-positive organisms, good activity against gramnegative organisms and viruses, minimal activity against TB and fair activity against fungi. It has minimal effect in the presence of organic matter, but is ototoxic and corneal toxic.29
Alcohol coagulates and denatures the cell protein. The reaction time is the most rapid while the persistence is short with rapid rebound growth. Alcohol concentration is important because it needs water to be effective. It has excellent activity against Gram-positive and Gram-negative organisms with good activity against TB, fungi and viruses. The effect against organic matter needs to be further studied. Alcohol dries the skin, is flammable and volatile, but continues to be one of the safest antiseptics.30
Alcohol in 60 percent to 95 percent strengths has been classified by the FDA under its 1994 TFM as Category I being safe and effective.31
Triclosan acts by disrupting the cell wall. The reaction time is intermediate while the persistence is excellent. It has good activity against Gram-positive, Gram-negative and TB organisms with poor against fungi and fair against viruses. Triclosan can be absorbed through the skin.32 The FDA TFM has classified Triclosan as a Category IIISE because the data is insufficient to classify it as safe and effective.33
Agents must be allowed to dry before the surgical drapes are applied. Sufficient time is required for drying of solutions that are flammable to decrease the possibility of fire.34
Before beginning preparation of the surgical site one must develop a plan of action by mentally visualizing the proposed incision. The area to be washed must accommodate extension of the incision, the need for additional incisions and possible drain sites. The skin preparation is begun at the incision site; using a circular motion, move in ever widening circles around the incision site working out to the periphery. Once the periphery has been reached the sponge is discarded. Never cross the path of the incision after beginning the circles around the incision to the periphery. The CDC’s 1999 guideline has put this type skin preparation into a Category II.35
The importance of preoperative skin preparation cannot be over emphasized in prevention of SSIs. Skin preparation is one important step in decreasing the number of microorganisms on the patient’s skin. Various antiseptic agents are available for use. The choice depends on the patient’s sensitivities, surgeon’s preference, the area of skin to be prepared and the skin condition at the incision site. AORN Standards state in the purpose “the goal of preoperative skin preparation is to reduce the risk of postoperative SSI.”36