Comparison of CHG Retention in a Repetitive Fluid Challenge with 2% CHG/70 % IPA Preoperative Skin Preparations.

Author(s):
Joan Paulson; Dan Morse; Angela Hollingsworth; Muhammed Hamid Bashir; Assumpta Bennaars-Eiden

Background:

Preoperatively, skin is treated with topical antiseptic products to minimize the risk of surgical site infections by reducing microorganisms on skin.  Chlorhexidine gluconate (CHG) is an antimicrobial used in preoperative skin preparations because of its broad-spectrum activity and persistent properties.  However, chlorhexidine is water-soluble leaving the possibility a CHG-formulation may be removed during surgery when prepped areas are exposed to fluid and repeated blotting.  The objective of this study was to evaluate the impact that the addition of an acrylate copolymer has in a CHG-containing preparation in minimizing CHG loss during simulated surgical irrigation and wiping procedures when compared with a CHG-containing preparation without a polymer.

Hypothesis:

Addition of a copolymer to 2% CHG/70 % IPA preoperative skin preparation improves retention of CHG on the skin during a surgical irrigation challenge.

Methods:

In this prospective-randomized, paired‑comparison study, 21 healthy volunteers were enrolled and had 2 test preparations, 2% CHG/70% IPA (polymer) and 2% CHG/70% IPA, applied to their back.  Test sites were randomized to pre-challenge (no repetitive saline soak/wipe) or post-challenge (repetitive saline soak/wipe).  Samples were collected using a modified cup scrub method; HPLC analysis measured CHG content.  Study endpoints: CHG (µg/cm²) removed during challenge; CHG (µg/cm²) remaining post-challenge.  Skin irritation was rated pre- and post-product application and adverse events were collected.  A Mixed Model ANOVA compared products for response of CHG concentration.

Results:

2% CHG/70% IPA (polymer) had significantly more CHG on skin than 2% CHG/70% IPA, both pre-challenge (14 µg/cm² more; p=0.001) and post-challenge (29 µg/cm² more; p<0.0001).  Significantly less CHG was removed from 2% CHG/70% IPA (polymer) sites (47.6 µg/cm²) than from 2% CHG/70% IPA sites (62.6 µg/cm²) post-challenge; the difference (15 µg/cm²) (p=0.012).  No skin irritation or adverse events were reported.

Conclusions:

Addition of a copolymer to a CHG-containing preparation resulted in more CHG on skin, both pre- and post-challenge, and less CHG removed in this repetitive saline soak/wipe model.  Both preparations were well-tolerated.