Prophylaxis of Surgical Wound Infection in Incisional Hernia Repair With Topical Antibiotics (PROTOP-PAR)
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
Surgical site infection (SSI) is the main complication of surgery. The prevention of
superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with
topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive
results. In experimental conditions there is evidence in favor of the efficiency wound lavage
with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety
and efficacy of antibiotic lavage.
Objective. Study of the efficacy of topical antibiotic therapy in the prevention of SSI in
patients undergoing incisional hernia repair after abdominal surgery.
Method. Randomized double-blind clinical trial comparing two groups of topical prophylaxis.
Follow-up will be 90 days after operation. Data will be collected anonymously and the
relationships between the variables will be analyzed using Pearson's chi-square, survival
analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on
hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.