Skin colonization and surgical site infections
Surgical site infections (SSIs) continue to present significant risks to patients undergoing a myriad of surgeries, as they increase morbidity, mortality, and healthcare costs. In combating SSIs, clinicians utilize a plethora of preoperative, intraoperative, and postoperative techniques. Given that multiple species of pathogenic bacteria frequently colonize the skin, preoperative preparation via cleansing near the incision site is commonly employed, since this practice reduces the bacterial load on the skin. By eliminating nearly all of the bacteria on the skin, cleansing reduces the potential for pathogens to colonize the incision site and cause an SSI.
ReadyPrep™ CHG 2% Pre-Saturated Cloth
The application of single-use antiseptic wipes represents a demonstrable and convenient method to reduce bacteria on the skin. Chlorhexidine gluconate (CHG) is a widely-used antiseptic with significant, broad-spectrum, antimicrobial activity, coupled with a long-history of use and low incidence of adverse events. To facilitate preoperative skin preparation, Medline Industries, Inc. now offers ReadyPrep™ CHG Cloth, which contains two preoperative skin preparation cloths, each pre-saturated with a 2% CHG solution that is equivalent to 500 mg CHG per cloth.
Two successful clinical studies
In two pivotal clinical trials, each with over 300 healthy subjects, ReadyPrep™ CHG Cloth significantly reduced the number of skin microorganisms when applied to a 5” × 5” location on the abdomen (non-sebaceous site) and a 5” × 2” location on the groin (sebaceous site).[4,5] The design of both studies was identical and followed the guidance provided in the 1994 Food and Drug Administration Tentative Final Monograph for Over-the-Counter Healthcare Antiseptic Drug Products.6 Subjects were exposed to two of three treatments: ReadyPrep™ CHG Cloth, a 2% liquid CHG solution (active control), and a ReadyPrep™ CHG Cloth that contained no CHG (placebo control). The primary endpoint was the proportion of “responders” at ten minutes post-treatment application; a responder was a subject that demonstrated a reduction in skin microorganisms at the application site that exceeded a threshold suggested by FDA. Measurements of skin microorganisms were also made six hours post application to ascertain product efficacy on a longer time scale.
Significant reduction in skin microorganisms in ten minutes, with effects lasting up to six hours
ReadyPrep™ CHG Cloth was the only treatment to meet the primary endpoint in both studies at both application sites. Application of ReadyPrep™ CHG Cloth significantly reduced the number of skin microorganisms, performing equally as well or better than the active control (liquid CHG). Six hours after ReadyPrep™ CHG Cloth application, all subjects had skin microorganisms lower than the baseline levels measured prior to product application.
Favorable safety profile
As part of the development of ReadyPrep™ CHG Cloth, more than 1,600 subjects in eight clinical studies were exposed to the product under conditions of therapeutic use.[4,5, 8-13] There were zero reports of serious adverse events across these studies. Mild-to-moderate skin irritation at the application site composed the vast majority of side effects in these studies; irritation was temporary, resolved completely, and was consistent with the known effects of 2% CHG on skin. Moreover, a pharmacokinetic study in 12 subjects confirmed that cutaneous exposure of ReadyPrep™ CHG Cloth did not result in systemic exposure to chlorhexidine. Finally, a study with 210 healthy subjects employed a three-phase immune sensitization protocol, and found that zero subjects displayed a reaction to the ReadyPrep™ CHG Cloth solution that would be indicative of a systemic immune response.
ReadyPrep™ CHG Cloth: Convenient and efficacious preoperative skin preparation
In two pivotal trials, Medline’s ReadyPrep™ CHG Cloth met the primary endpoint for efficacy in reducing skin microorganisms at ten minutes post-treatment, and the number of microorganisms remained suppressed six hours after initial treatment. By significantly reducing skin microorganisms, ReadyPrep™ CHG Cloth represents a critical tool in overall preoperative patient preparation to prevent surgical site infections.
For more information, visit www.medline.com/pages/chg/.
aThe formulation tested in these studies and all ReadyPrep™ CHG Cloth studies referenced contained two inactive ingredients not present in the final commercial formulation. An in vitro time-kill bridging study determined that the commercial formulation and the formulation used in the pivotal efficacy studies were equally effective.
1. Leaper D, Ousey K. Evidence update on prevention of surgical site infection. Curr Opin Infect Dis. 2015;28(2):158-163.
2. Septimus EJ, Schweizer ML. Decolonization in Prevention of Health Care-Associated Infections. Clin Microbiol Rev. 2016;29(2):201-22.
3. McDonnell G, Russell AD. Antiseptics and Disinfectants: Activity, Action, and Resistance. Clin Microbiol Rev. 1999;12(1):147-79.
4. Data on file. Medline Industries Study #R13-053.
5. Data on file. Medline Industries Study #R15-029.
6. Food and Drug Administration. Tentative final monograph for healthcare antiseptic drug products; proposed rule. Federal Register 1994; 59:31401-52.
7. Data on file. Medline Industries Study #R17-004.
8. Data on file. Medline Industries Study #R13-052.
9. Data on file. Medline Industries Study #R15-029.
10. Data on file. Medline Industries Study #R16-034.
11. Data on file. Medline Industries Study #R17-023.
12. Data on file. Medline Industries Study #R13-042.
13. Data on file. Medline Industries Study #R14-015.
14. Data on file. Medline Industries Study #R13-051.