PLaSSo
Trial question
What is the role of peritoneal and wound lavage with super-oxidized solution in patients undergoing open appendicectomy for perforated appendicitis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 102
102 patients (26 female, 76 male).
Inclusion criteria: patients aged ≥ 13 years with perforated appendicitis undergoing open appendicectomy.
Key exclusion criteria: gangrenous, suppurative, or exudative appendicitis; laparoscopic appendicectomy or midline laparotomy; corticosteroid or immunosuppressive therapy.
Interventions
N=51 super-oxidized solution (Hydrocyn Aqua®).
N=51 normal saline (sodium chloride 0.9% solution).
Primary outcome
Rate of surgical site infections within 30 days after surgery
15.6%
37.2%
37.2 %
27.9 %
18.6 %
9.3 %
0.0 %
Super-oxidized
solution
Normal
saline
Significant
decrease ▼
NNT = 4
Significant decrease in the rate of surgical site infections within 30 days after surgery (15.6% vs. 37.2%; RR 0.42, 95% CI 0.2 to 0.87).
Secondary outcomes
No significant difference in mean duration of ileus (14.88 hours vs. 16.29 hours; MD -1.41, 95% CI -4.84 to 2.03).
No significant difference in mean elevation in CRP levels at 24 hours versus 48 hours (32.42 mg/L vs. 30.88 mg/L; MD 1.54, 95% CI -9.38 to 12.46).
No significant difference in hospital readmission (5.9% vs. 7.8%; RR 0.75, 95% CI 0.18 to 3.18).
Conclusion
In patients aged ≥ 13 years with perforated appendicitis undergoing open appendicectomy, super-oxidized solution was superior to normal saline with respect to the rate of surgical site infections within 30 days after surgery.
Reference
Harivinthan Sellappan, Dinesh Alagoo, Christina Loo et al. Effect of peritoneal and wound lavage with super-oxidized solution on surgical-site infection after open appendicectomy in perforated appendicitis (PLaSSo): randomized clinical trial. BJS Open. 2024 Sep 3;8(5):zrae121.
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