Thoughts on options for skin cleaning prior to body art procedures.

If a product is not labeled for surgical preparation, it really doesn’t matter how good of a hand and body soap or cleanser it is. It would only be a really strong hand wash product, or possibly aftercare for our purposes.

Choose a product that has claims as a “surgical skin preparation” because “scrub” alone is only the first step as cleaning. A two step “scrub then paint” process is appropriate and advised by CDC.  That involves a solvent or detergent scrub to clean followed by the surgical antiseptic to kill microbes to an irreducible minimum level of contamination.

What does the evidence suggest that we use?

• I’ve been using FDA approved skin prep PVP-I, CHG or alcoholic CHG, or alcohol depending on the area, with a preference for sterile products, and keep looking for other safe, appropriate options.
• For oral preparation, an antiseptic mouthwash containing CPC or dilute H2O2 and friction.

I’m still looking for a universal surgical preparation agent, and have not found anything on the market that is both proven and FDA approved other than PVP-I, CHG based products and alcohol. I don’t want to recommend anything unless it is tested and labeled for the purpose.

CDC HICPAC Table follows

Table 6. Mechanism And Spectrum Of Activity Of Antiseptic Agents Commonly Used For Preoperative Skin Preparation And Surgical Scrubs

Download the complete PDF version Guideline for Prevention of Surgical Site Infection, 1999 [PDF – 217 KB]. 2017 version here

Agent	Mechanism of Action	Gram-Positive Bacteria	Gram-Negative Bacteria	Mtb	Fungi	Virus	Rapidity of Action	Residual Activity	Toxicity	Uses
Alcohol	Denature proteins	E	E	G	G	G	Most rapid	None	Drying, volatile	SP, SS
Chlorhexidine	Disrupt cell membrane	E	G	P	F	G	Intermediate	E	Ototoxicity, keratitis	SP, SS
Iodine/Iodophors	Oxidation/substitution by free iodine	E	G	G	G	G	Intermediate	Minimal	Absorption from skin with possible toxicity, skin irritation	SP, SS
PCMX	Disrupt cell wall	G	F*	F	F	F	Intermediate	G	More data needed	SS
Triclosan	Disrupt cell wall	G	G	G	P	U	Intermediate	E	More data needed	SS

Abbreviations: E, excellent; F, fair; G, good; Mtb, Mycobacterium tuberculosis; P, poor; PCMX, para-chloro-meta-xylenol; SP, skin preparation; SS, surgical scrubs; U, unknown. Data from Larson E.[176] * Fair, except for Pseudomonas spp.; activity improved by addition of chelating agent such as EDTA.

Common perioperative skin preparation antiseptics

CHG (chlorhexidine gluconate – with or without linear alcohol)

Effective, but possibly hazardous for mucous membranes, or around eyes and ears.

PVP (PVP-I, polyvinylpyrrolidone iodine)

Effective, but possibly not safe for people who are allergic to iodine, in some cases.

What do I think is better: Betadine scrub and Betadine (PVP) or Hibiscrub and Hibitane (CHG)?

Either of the two ingredients can be used for skin prep, and these are familiar, proven brand names. I’m primarily using PVP, and CHG as an alternate for individuals concerned with iodine sensitivity. The scrub is only the first step for cleaning, followed by the antiseptic. A scrub can also for hand washing and for bathing prior to major surgery, or for aftercare after major contaminated surgery, but should not be used for body piercing aftercare.

Some comparison points:

• CHG products kill faster and last longer, but are more toxic to the client and the environment.
• CHG does not leave a stain like iodine
• In regards to the use of CHG solution for piercing skin prep, a representative from the  Hibiclens brand  manufacturer implies that it should be safe for use for piercing site prep (which is backed by evidence based medical studies):
  • since we are not prepping people who are under anesthesia,
  • eyes self-flush with tears,
  • and the risk of ear damage is minimal since
    • clients are usually aware that they have a perforated eardrum
    • it is difficult to push the liquid through the eardrum
  • I have asked the manufacturer to confirm this, and to provide a protocol for body piercing skin preparation.
• PVP products may cause allergic reactions, but these reactions are very uncommon.
• PVP leaves a brown stain on skin, which is helpful to visualize the area that has been cleaned, but should be rinsed after the procedure.
• PVP can stain clothing and surfaces if spilled.

The best choice is to just follow the package labeling. Some PVP [povidone iodine prep] products dry very quickly [30 seconds to 1 minute] and only require two applications, one for cleaning, degreasing and removing debris, the second for antisepsis. I find they work well enough that by the time I’ve prepped, cleaned my hands and donned sterile gloves, when I return to the site they are dry. With prep agents, especially PVP, is that they must be allowed to dry before you pierce/mod.

Before the skin preparation of a patient is initiated, the skin should be free of gross contamination (i.e., dirt, soil, or any other debris).187 The patient’s skin is prepared by applying an antiseptic in concentric circles, beginning in the area of the proposed incision. The prepared area should be large enough to extend the incision or create new incisions or drain sites, if necessary.[1,177,187] The application of the skin preparation may need to be modified, depending on the condition of the skin (e.g., burns) or location of the incision site (e.g., face). There are reports of modifications to the procedure for preoperative skin preparation which include: (1) removing or wiping off the skin preparation antiseptic agent after application, (2) using an antiseptic-impregnated adhesive drape, (3) merely painting the skin with an antiseptic in lieu of the skin preparation procedure described above, or (4) using a “clean” versus a “sterile” surgical skin preparation kit.[188-191] However, none of these modifications has been shown to represent an advantage. — CDC Guideline for Prevention of Surgical Site Infection, 1999

Why not remove residue before working?

PVP is only active while it is on the skin, once wiped off, there is no residual antiseptic effect. Some people use PVP by multiple applications, letting each dry, then before the procedure rinsing with sterile water or sterile saline and patting dry with sterile gauze. The area should not be rinsed before the procedure as it reduces or negates the desired prolonged germicidal effects. After the procedure, many clients don’t want an iodine stain on their new piercing. I suggest you leave it on for the procedure, and wipe off after with  sterile water or sterile saline wipes to remove the stain and soothe the pierced area.

I make my own wipes as well by moistening a gauze compress with a few drops of distilled water, and sterilize it along with the jewelry, separated from the rest of the dry items in my Statim autoclave cassette tray organizer.

Here are images of some of the ones I’ve used. (PDI is only one of many brands.) I like sterile swab sticks best, so that they can be used with a no-touch technique, but swab pads can be used effectively, and tend to be the economical choice.

Sterility

The FDA held a hearing to inquire into contamination of antiseptic products. 12-12-12 FDA HHS Public Hearing  on the Sterility of Antiseptic Patient Preoperative Skin Preparation Products:_Full Transcript The specifics of this event were to determine if the need for antiseptics that were free from contamination was being met.

02/07/2013 APIC responded to a request from the U.S. Food and Drug Administration (FDA) to provide input on how to address microbial contamination of preoperative skin preparation products, following an FDA hearing on the same subject. View APIC’s comments.

Note: Some Triad brand products of these types were recalled in 2008 FDA reminds health care professionals about safe use of non-sterile alcohol prep pads

“Health care professionals should always check the labeling on a prep pad to determine if it is sterile or non-sterile,” said Karen Weiss, M.D., director of the Safe Use Initiative in the FDA’s Center for Drug Evaluation and Research. “Non-sterile pads are not intended to prep patients prior to procedures requiring strict sterility measures and should not be used on patients with a depressed immune system, to prep patients for catheter insertion, or to prep patients prior to surgery.” Weiss said many patients in hospitals are particularly susceptible to infections, and the FDA recommends sterile antiseptics (including chlorhexidine gluconate, alcohol or iodine applicators, pads, and swabs) in that setting. Manufacturers often package a prep pad with an injectable drug, selling them as a kit. But not all marketed pads are sterile. Some are marketed as non-sterile alcohol pads. If a pad does not state “sterile” on the label, health care professionals should be aware that they are using a non-sterile pad. Health care professionals and consumers should check the label to confirm that the product is sterile, and may also want to consider washing the area with soap and water prior to using the antiseptic for skin surface preparation. For more information:

• Triad Group Press Release on Recall of Alcohol Prep Pads
• CDC – Guideline for Prevention of Surgical Site Infection
• Interpretation of this CDC guideline for piercing
• Sterility of Antiseptic Products: FDA Investigates, Deliberates on Potential Recommendations [for a limited time only]

Honorable mention

Alcohol (Isopropyl alcohol)

Standard of Practice III

Alcohol is an accepted antiseptic agent; however, it should not be used as the single agent but as part of the skin prep regimen. AST Recommended Standards of Practice for Skin Prep of the Surgical Patient

Octenidine dihydrochloride (Octeniderm®, OCTENSEPT®)

I got samples of alcoholic octenidine dihydrochloride products from Schülke and Mayr a while ago while at BMXnet. it seems like a decent antiseptic for preparation of puncture sites, and has some advantages and disadvantages [1] [2]. It is available in some countries in Europe and Asia, and is not available in North America.

Techni-Care Status Update:

Out of production from 2009-2014

May 9th, 2011 At this time the FDA is in our corporate office doing a complete inspection.
Thank you for your patience and understanding, Marlene Carney —Care-Tech Laboratories, Inc. 

Techni-Care was labeled for surgical skin preparation, patented, had specific written protocol, and they claimed it was tested for FDA approval. It was removed from the market in 2009 and reintroduced in 2014. Now back on the market after undergoing another testing review for the FDA, a sterile single serving version could be interesting.

Available again in 2014

We are pleased to announce that CARE-TECH received notification on August 7, 2014 that we have satisfied the FDA on CGMP (Current Good Manufacturing Requirements for Pharmaceutical Companies) and will resume manufacturing and distribution of TECHNI-CARE Antiseptic on September 8, 2014. We appreciate your patience and support during this very lengthy process and look forward to once again shipping CARE-TECH technology for the patients and medical professionals who need this product.

Technicare FAQ & MSDS

Prep Procedures

• Facial Skin Prep Procedure
• Recto-Perineal/Vaginal Prep Procedures
• Surgical Scrub Procedure
• Skin Prep Procedure

Agents not labeled for surgical skin preparation

I believe in suggesting people only use products for skin preparation that have FDA and EPA label claims for that.  Problems could arise if we use hand care products for skin prep.

Opti-scrub

I’m not sure how Opti-scrub has been labeled, tested or presented for purpose. I’d like to know more, for what it’s worth it appears to be a decent hand (and foot) wash product. Opti-scrub seems reasonable for hands and for showering but using it for skin prep would be an off label use. It’s not proven for that as far as I can tell. Ryan Ouellette wrote an article describing his experience with it for The Point, the official journal of the APP

Microsan rx

I looked into this and I like the idea of the hand sanitizer, an alcohol free foaming quaternary ammonium based product, labeled for tattoo and piercing skin prep. The company has been forthcoming with information and discussed FDA label claims and efficacy data. I am following up with them now.

Microsan_rx^® is a health care professional anti-microbial skin cleanser that is effective in killing 99.999% of susceptible organisms in 30 seconds or less. Its high potency and fast action make Microsan_rx^® ideal for use in areas where frequent hand washing is important. Microsan_rx^® Health Care Professional Skin Cleanser is a liquid soap that, not only disinfects, but also leaves the skin feeling clean and moisturized. Use of Microsan_rx^® by healthcare workers significantly reduces the spread of nosocomial infections such as MRSA and VRE. Simply wash the hands with 1-2 pumps of Microsan_rx^® Healthcare Professional Hand Wash. Rinse and dry the hands.

The label:

Ryan Ouellette wrote an article describing his experience with it for The Point, as well. However, I don’t see anywhere in the product literature any claims that Microsan RX is an FDA approved skin prep as he mentioned here:

Microsan RX has also been formulated and tested to be a safe and effective skin prep for both oral and genital mucosa. Ryan Ouellette, The Point, issue 56, page 16

Ryan Ouellette, The Point, issue 56, page 16

It seems that it could be used safely as a scrub to clean the area prior to using another FDA approved surgical skin prep antiseptic. Companies are trying to market Opti-scrub and Microsan to the body art industry as Techni-Care replacements, but they seem closer to the CareTechLabs Satin hand and body wash aftercare product.

Primasept

I don’t believe that this will be a solution. It is not a surgical skin prep, it is a hand/body washing agent.

BZK benzalkonium chloride

Not really effective as a germicide, more of a detergent. Incompatible with PVP iodine. Betadine, Hibiclens [and the generics], and others listed in the CDC table above are tested and labeled for surgical skin preparation use.

Not yet available labeled as a skin preparation agent in the US, but sold in Canada, Australia and New Zealand

PURKLENZ  (Parachlorometaxylenol)

• A promising product based on PCMX, with some similarities to Techni-Care. A written protocol for use in body art is a plus.
• However, I strongly disagree with the use of a non-sterile bulk product for lubrication of a sterile needle as described for the PurKlenz and the complementary product PurTect. That could be a source of contamination, and further cross contamination as it is not a single use product.
• I have discussed at length the need for single use sterile applicators with the manufacturer, and look forward to them being produced.
• Manufacturer information and BodyArtPro distributor

 Further information:

• A presentation on skin prep antiseptics:
• Here are the AST Recommended Standards of Practice for Skin Prep of the Surgical Patient
• Here is a bit from AORN about using skin prep products off their label direction:

QUESTION: What is AORN’s recommendation about using a product contrary to its label warnings?

ANSWER: The perception that a special dispensation can be acquired from the FDA is erroneous. According to the FDA, there is no mechanism for providing waivers for using products contrary to the label warning. (1) AORN recommends following the label on the skin preparation product just as for any other medical product. (2) Any decision to use a product in a manner contrary to the product’s label warnings should be carefully and thoroughly considered by a multidisciplinary group that includes surgeons, perioperative RNs, anesthesia care providers, a risk manager, and an infection control professional. The health care facility may be assuming liability if a decision is made to use a product in a manner contrary to the label warning.

In addition:

QUESTION: A surgeon at our facility has requested a specific skin preparation agent. He believes the product he is requesting is a superior product that has an excellent microbial kill rate with good residual persistence. The product literature instructions direct the user to use a back-and-forth or side-to-side motion to apply the prepping solution. The manufacturer’s suggestions for performing the skin prep conflict with AORN recommended practices. Has AORN changed its recommendations for performing surgical skin prep?

ANSWER: AORN continues to recommend starting the surgical skin prep at the incision site and progressing to the periphery. (2) This is congruent with the CDC’s “Guidelines for prevention of surgical site infections, 1999” statement: “The patient’s skin is prepared by applying an antiseptic in concentric circles, beginning in the area of the proposed incision.” (3) This practice standard is supported by theoretical epidemiological rationale for preventing microbial contamination from the periphery from being introduced onto the prepped incision area. When back-and-forth or side-to-side motion is used, the tip of the prep applicator may become contaminated from the peripheral linen and towels. AORN’s recommended practices state that the sponge/applicator “should be discarded after the periphery has been reached.” (2(p604)

• Also, a really helpful presentation from the FDA about surgical skin preparation
  
  
• Why the next skin prep fad will hurt body piercing a useful analysis, by Jef Saunders
• Pre-Piercing Skin Prep (or What To Do When You Run Out of Techni-Care), by Elayne Angel
• The APP 2013 Procedure Manual manual states:

  “Chemical agents selected for skin prep should have the following properties:

  • A broad-spectrum antimicrobial action
  • Rapid activation and prolonged effectiveness
  • Minimal irritation/sensitization potential
  • Quick and convenient application

    The “health care facility [body piercing studio] should use FDA-approved agents that have immediate, cumulative, and persistent antimicrobial action.”

    “In the US, antiseptic agents are regulated by the FDA’s Division of Over-the-Counter Drug Products.”

Nasal preparation

Read more at my link here: Nasal antiseptics

Oral preparation

• Antisepsis prior to oral procedures is valuable and has measurable results. https://www.ncbi.nlm.nih.gov/pubmed/19167188
• A description of antiseptics used in oral and maxillofacial surgery here

  An Introduction to Oral and Maxillofacial Surgery

  books.google.com

• Betadine oral preparation https://home.intekom.com/pharm/adcock/betadn-o.html

• Oral surgical antisepsis and sterile gloves https://www.dentistryiq.com/articles/2010/11/surgical-hand-antisepsis-and-donning-sterile-gloves.html

  Surgical hand antisepsis and donning sterile gloves – DentistryIQ

  www.dentistryiq.com

• “Controversy exists as to which agents provide the best antisepsis for the oral cavity prior to invasive procedures.”
  https://ebd.ada.org/SystematicReviewSummaryPage.aspx?srId=44337547-07be-4b70-9012-735a6addb22e