SSI Prevention Protocol – Clinical Evidence Dossier

Evidence-based rationale for incorporating Clenivax™ chlorhexidine/isopropyl alcohol applicators in hospital surgical site infection (SSI) prevention bundles, aligning with CDC, WHO, and national quality programs.

1. SSI Burden & Rationale

2–5%

Average SSI incidence for inpatient surgeries (CDC)

$11.7K

Median attributable cost per SSI event (Agency for Healthcare Research and Quality)

~60%

SSI events considered preventable with evidence-based bundles (WHO)

2. Comparative Effectiveness

StudyPopulationResultRelevance
Darouiche et al., NEJM 2010 n=849, clean-contaminated surgery CHG/IPA vs. PVP-I: 41% SSI reduction Supports CHG/IPA as preferred agent for SSI prevention bundles.
Swenson et al., Ann Surg 2009 Colorectal surgery bundle implementation SSI rate reduction from 16% to 6% using CHG/IPA prep Demonstrates multi-modal bundle impact.
WHO SSI Guidelines 2016 Meta-analysis of 13 RCTs Moderate-quality evidence favors alcohol-based antiseptic International recommendation aligned with Clenivax™ formulation.
Full bibliography includes 60+ peer-reviewed publications, available to Infection Prevention committees upon request.

3. Protocol Integration

National Quality Programs

WHO SSI 2016 Bundle Elements

4. Procedure-Specific Guidance

Orthopedic Implant Cardiac Surgery Neurosurgery General Abdominal Obstetric & Gynecology Vascular Access

Clenivax™ applicators are offered in sizes 1 mL, 3 mL, 10.5 mL, and 26 mL to match procedural needs, ensuring full field coverage within recommended wet contact times.

5. Implementation Toolkit

6. Outcome Tracking

Our clinical affairs team partners with hospitals to monitor outcomes:

References

  1. Darouiche RO et al. N Engl J Med. 2010;362:18-26.
  2. World Health Organization. Global Guidelines for the Prevention of Surgical Site Infection. 2016.
  3. Anderson DJ et al. Infect Control Hosp Epidemiol. 2014;35(6):605-627.
  4. Swenson BR et al. Ann Surg. 2009;250(6):952-958.