WOUND SOLUTIONS

Sterile vs. nonsterile: Controversy continues

Individual assessments necessary

Question: Are sterile gloves needed when someone uses a "no-touch" technique when applying dressings? I’ve been told that at some facilities, nurses are not required to wear sterile gloves, but I’d like to know what the accepted practice is.

Answer: Your question raises a number of important wound care issues, such as the meanings of the terms sterile, clean, no-touch, and nonsterile, and the reimbursement, ethical, and legal implications for using or not using sterile techniques. Earlier this year, several wound care experts from Canada and the United States met in Toronto to discuss these and related issues. Toronto-based Dumex Medical Surgical Products Ltd. sponsored the program.

The panel’s goal was to examine the advantages and disadvantages of sterile vs. nonsterile wound care. Proceedings of the meeting have been published in a monograph, and excerpts of the monograph follow below.1 (To obtain a copy of the complete monograph, see Editor’s note at end of article.) The meeting participants cautioned that their conclusions and recommendations are not intended to be definitive answers to the debate about sterile vs. nonsterile wound care, but a starting point designed to raise the awareness of wound care professionals.

The panel had four objectives:

1. Define sterile vs. nonsterile wound care.

2. Describe specific issues related to sterile vs. nonsterile wound care options.

3. Assess and critically evaluate the research literature and evidence base for sterile vs. nonsterile wound care.

4. Identify specific recommendations for clinical practice that may be appropriate for the readers of the monograph.

Terms sterile,’ clean’ used inconsistently

The debate about sterile technique vs. clean technique has been ongoing for decades now, but there is no consensus on which approach is applicable under various given circumstances. Even the actual terms sterile, clean, and nonsterile have many different meanings for health care providers, and the definitions clinicians attribute to those words are often overly broad and inconsistent with Clinical Practice Guidelines for the Treatment of Pressure Ulcers set forth by the Agency for Health Care Policy and Research (AHCPR).

In one unpublished study, about half the respondents said they would use sterile gloves and sterile irrigant when applying sterile technique, and about a quarter said they’d use sterile dressings with sterile technique. The majority said they would save the unused irrigant and reuse the scissors.2

Because the definitions in this discussion are not consistent, the subject becomes rather complex and the standard of care is unclear. (See box of definitions, p. 127.)

The panel agreed that there are no definitive answers to the sterile vs. nonsterile controversy, and that the assessment of individual patients is necessary for wound care professionals to make decisions about sterile vs. nonsterile technique so the bioburden is minimized and no harm is done.

"When you look at a chronic wound, there is always a bacterial load; it may be contaminated, colonized, or infected. And it is important to make distinctions about what technique you are going to use at those three levels," said panel member Gary Sibbald, MD, a dermatologist and associate professor of medicine at the University of Toronto.

With regard to wound care technique, the panel noted that safety concerns and reduction in risk to the patient are paramount. And because the health care provider is frequently a vector for the spread of infection, proper hand washing should be considered just as important as the type of wound care technique applied.

"The use of universal precautions is without doubt the most essential and reasonably prudent care approach," the panel said, defining universal precautions as "a system of infection control which assumes that every direct contact with body fluid is potentially infectious," or "when blood-body fluid precautions are consistently used for all patients, irrespective of diagnosis." Still, details of gloving, gowning, barriers, masks, instruments, and product selection will vary depending on setting, wound type, and real-world considerations.

In a 1994 article, no-touch technique was advocated as a reasonable compromise until research on this issue was available to guide practice.3 In no-touch technique, dressings, solutions, and instruments that come into direct contact with the wound are sterile. Supplies that do not come into direct contact with the wound, such as barriers and gloves, are nonsterile. This technique, the authors wrote, provides an optimal level of sterility while saving time and money without compromising the gold standard of sterile wound care.3

Also in 1994, the AHCPR issued its Clinical Practice Guideline for Treatment of Pressure Ulcers,4 which suggests that clean technique be used for pressure ulcer care. The panel noted that the AHCPR recommendations were based on expert opinion and not on evidence-based research.

The panel proposed that clinicians evaluate individual patient situations and make educated, common-sense decisions when choosing wound care techniques.

Product selection

The panel cautioned that health care providers have a responsibility to use "common sense and good judgment" when selecting the status (sterile or nonsterile) of products used in wound care. The panel’s preference is to use sterile products whenever possible. One reason for this is that there are no regulatory specifications whatsoever regarding the bioburden of products that are not sterilized.

"Products that are sterile, that are single-use or unit-dose are safest and most user friendly," said the panel. "Minimizing cross-contamination and the transfer of microbes by the use of aseptic technique and a conscious, careful attitude can help us reduce contamination and minimize harm. Individual assessment of the patient situation and the wound is essential for defining the particular parameters of aseptic technique for each patient situation."

The panel’s other opinions include the following:

High-risk populations: The panel recommended more conservative treatment whenever possible for high-risk populations, which include patients who are immunocompromised or have concurrent conditions such as hypoxia, impaired perfusion, or malnutrition, and those undergoing radiation therapy. It seems logical, the panel stated, to to err on the side of caution by reducing bioburden and risk of contamination.

Reimbursement and legal issues: The panel suggested that health care providers in the United States review their DMERC surgical dressing policies and other payer policies carefully and use caution when billing for nonsterile wound care supplies for Medicare patients. There also may be a legal risk in using nonsterile products when research supporting such a decision is lacking or inconclusive. Once again, the panel recommended that practitioners should be advocates for their patients and err on the side of caution.

Using research study information for decision making: The panel advised caution when using research studies that address the issue of clean vs. sterile technique, because the scientific foundation for decision making in this area is shaky. Common definitions are lacking, and identification of important variables are often unclear or missing. Still, the panel cited six recent publications as examples of interest in the subject (see box at right for details).

While noting that the sterile vs. nonsterile issue is complex, the panel proposed a number of recommendations to optimize care and reduce bioburden to a minimum, including:

Whenever possible, choose wound care products that have been sterilized and are single-use.

Select the correct size of product and minimize waste.

Consider no-touch technique to reduce costs while maintaining sterile wound care.

Be specific with dressing change orders. Specify the exact number and size of dressings to be used.

When making treatment decisions, weigh variables such as wound type, etiology, phase, size, depth, amount of drainage/exudate; the presence of infection and/or odor; the change in pain level; the condition of wound edges and margins; and patient risk factors, medication, and nutritional status.

Educate the health care team about dressing protocols.

Expose colleagues to the issues surrounding sterile vs. nonsterile wound care.

Encourage a team approach to wound care.

To obtain a free copy of the monograph, contact Dumex Medical Surgical Products Ltd., Toronto, at (800) 463-0106, ext. 248.

References

1. Krasner D, Cooling M, Hyder T, et al. Sterile versus nonsterile wound care. Contemporary Concepts in Wound Care 1998; 1.

2. Faller NA. A survey exploring the ET Nursing art of wound care: Factors associated with clean versus sterile technique. Unpublished doctoral dissertation. Amherst, MA: University of Massachusetts; 1997.

3. Krasner D, Kennedy KL. Using no-touch technique to change a dressing. Nursing 1994; Sept:50-52.

4. Bergstron N, Bennett MA, Carlson CE, et al. Treatment of Pressure Ulcers. Clinical Practice Guideline No. 15. AHCPR Publication No. 95-0652. Rockville, MD: US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research; December 1994.