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<p>Surgical site infections (SSI) is a common complication after laparotomy and is associated with increased morbidity, length of hospital stays, and healthcare costs. Multiple methods have been adopted to reduce SSI rates, including prophylactic intraoperative wound irrigation (IOWI), however, there are no clear guidelines. Polyhexanide (PH) is approved for soft tissue infections. The objective is to&#xa0;evaluate the efficacy of subcutaneous IOWI with 0.04% PH in reducing SSI in elective laparotomies compared to 0.9% normal saline (NS) and 1% povidone-iodine (PI) irrigation. This was a single-centre, double-blinded, prospective, multi-arm randomized controlled trial with three parallel treatment groups, comparing wound irrigation with 0.9% NS, 1% PI, and 0.04% PH in elective laparotomies. The primary endpoint was the rate of SSI within 30&#xa0;days postoperatively, and the secondary endpoints was postoperative pain and length of hospital stay and postoperative complications. Three hundred fifty-four patients were randomly assigned to the saline (<i>n</i> = 118), povidone-iodine (<i>n</i> = 118), or polyhexanide (<i>n</i> = 118) groups. Significant decrease in SSI incidence in the PH group compared to the NS and PI groups [odds ratio (OR) 2.64; 95%confidence interval (CI) 1.40–4.97; <i>p</i>-value = 0.003] was noted. Secondary outcomes like the length of hospital stay (<i>p</i>-value = 0.369) and postoperative pain (<i>p</i>-value = 0.270) and postoperative complications were comparable in all three groups. IOWI following midline laparotomy using 0.04% PH is safe and effective at reducing the risk of SSI.</p>

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Comparison of the Efficacy of Prophylactic Intraoperative Wound Irrigation with 0.04% Polyhexanide with 1% Povidone-Iodine and 0.9% Saline Irrigation for Preventing Superficial Surgical Site Infections in Patients Undergoing Elective Midline Laparotomy—A Double-Blinded Multi-arm Randomized Control Trial

  • 期刊论文

  • 发表日期：

    2025年7月11日

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  • Avinash S. R.,
  • Sagar Prakash,
  • Oseen Hajilal Shaikh,
  • Chellappa Vijayakumar,
  • Uday Shamrao kumbhar,
  • Harichandrakumar K.T.

摘要

Surgical site infections (SSI) is a common complication after laparotomy and is associated with increased morbidity, length of hospital stays, and healthcare costs. Multiple methods have been adopted to reduce SSI rates, including prophylactic intraoperative wound irrigation (IOWI), however, there are no clear guidelines. Polyhexanide (PH) is approved for soft tissue infections. The objective is to evaluate the efficacy of subcutaneous IOWI with 0.04% PH in reducing SSI in elective laparotomies compared to 0.9% normal saline (NS) and 1% povidone-iodine (PI) irrigation. This was a single-centre, double-blinded, prospective, multi-arm randomized controlled trial with three parallel treatment groups, comparing wound irrigation with 0.9% NS, 1% PI, and 0.04% PH in elective laparotomies. The primary endpoint was the rate of SSI within 30 days postoperatively, and the secondary endpoints was postoperative pain and length of hospital stay and postoperative complications. Three hundred fifty-four patients were randomly assigned to the saline (n = 118), povidone-iodine (n = 118), or polyhexanide (n = 118) groups. Significant decrease in SSI incidence in the PH group compared to the NS and PI groups [odds ratio (OR) 2.64; 95%confidence interval (CI) 1.40–4.97; p-value = 0.003] was noted. Secondary outcomes like the length of hospital stay (p-value = 0.369) and postoperative pain (p-value = 0.270) and postoperative complications were comparable in all three groups. IOWI following midline laparotomy using 0.04% PH is safe and effective at reducing the risk of SSI.