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Grand Rounds

RCT Results: Skin Prep Solutions for Gynecological Laparoscopy and Surgical Site Infections Rates

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BACKGROUND AND PURPOSE:

  • The best strategies for preventing surgical site infection following gynecological laparoscopies are not well understood
  • Dior et al. (JAMA Surg., 2020) compared different types of skin preparation solutions used during gyn laparoscopic surgeries and their impact on subsequent surgical site infection rates

METHODS:

  • Double-blind randomized clinical trial
  • Participants
    • ≥18 years
    • Elective operative laparoscopy for benign gynecological disorders (excluding urogynecologic surgery)
  • Interventions
    • Alcohol-based chlorhexidine
    • Alcohol-based povidone-iodine
    • Water-based povidone-iodine
  • Study design
    • Participants were randomized 1:1:1 to an intervention group for pre-surgical skin cleaning
    • Patients received pre-op prophylactic antibiotics as per routine
    • Follow-up at 1 and 4 weeks
    • Evidence of infection based on CDC criteria
  • Power analysis
    • Power level 80% | 2-tailed | P < .05
    • Clinical significance: 10% absolute difference between ≥2 of the treatments
    • Required sample size: 198 in each group
  • Primary outcome
    • Port-site infection 30 days after surgery
  • Secondary outcomes
    • Organ or space infections
    • Any type of surgical site infections

RESULTS:

  • 661 patients were randomized | 98.6% follow-up
    • Mean (SD) age: 36.2 (10.6) years
    • Water-based povidone-iodine: 221 patients
    • Alcohol-based povidone-iodine: 220 patients
    • Alcohol-based chlorhexidine: 220 patients
  • Surgical site infection rates
    • Port-site infection: 10.2%
    • Organ or space infection: 6.6%
    • Any surgical site infection: 16.3%
  • Infection was associated with
    • History of SSI | Older age | BMI
    • Total laparoscopic hysterectomy associated with
      • Any organ or space infection (OR, 4.17; 95% CI, 1.47 to 11.84)
      • Vault infections (OR, 25.47; 95% CI, 2.11 to 308.17)
  • The odds ratio (OR) of port-site infection was similar for all intervention groups
    • Alcohol-based chlorhexidine vs water-based povidone-iodine
      • OR 1.13 (95% CI, 0.61 to 2.08)
    • Alcohol-based chlorhexidine vs alcohol-based povidone-iodine
      • OR 1.34 (95% CI, 0.71 to 2.52)
    • Water-based povidone-iodine vs alcohol-based povidone-iodine
      • OR 1.19 (95% CI, 0.62 to 2.27)

CONCLUSION:

  • Overall rate of any surgical site infection (16.3%) was higher than expected and involved mainly incisional port-site infections
  • None of the surgical prep solutions was superior to the others
  • The authors state that while antibiotics reduce risk for surgical site infections

…no skin preparation solution provides an advantage by reducing infection during gynecological laparoscopy
Exploring other methods such as routine bathing or cleaning, specific preparation of the umbilicus, and antibiotic prophylaxis protocols to reduce SSIs in patients undergoing gynecological laparoscopies is warranted

Learn More – Primary Sources:

Effect of Surgical Skin Antisepsis on Surgical Site Infections in Patients Undergoing Gynecological Laparoscopic Surgery A Double-Blind Randomized Clinical Trial

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Related ObG Topics:

Evidence-Based Gynecologic Surgery Best Practices: The AHRQ Safety Program
Preoperative Bowel Prep for Gyn Surgery: Does It Actually Improve Surgical Outcomes?
ACOG Guidance on Preventing Gynecologic Post-Procedure Infection

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