Antibiotic Prophylaxis in Metabolic Bariatric Surgery

SUMMARY Rationale: Prophylactic antibiotics in laparoscopic surgeries, including Metabolic Bariatric Surgery (MBS), are routinely provided to reduce postoperative infections, especially at wound incision sites. However, since incisional wound infections in laparoscopic MBS are rare and morbidity is very low, the benefit of antibiotic prophylaxis is questionable. Objective: Evaluate the non-inferiority of omitting antibiotic prophylaxis in MBS. Compare postoperative outcomes between Group A (no antibiotics) and Group B (standard antibiotic care) to determine if omission increases complications, particularly wound infections. Study Design: Randomized controlled trial (RCT), double-blind. Study Population: Patients with obesity eligible for MBS. Intervention: * Group A (No Antibiotic Prophylaxis): Undergo MBS without antibiotics to test safety regarding postoperative complications, focusing on surgical site infections (SSIs). * Group B (Standard Antibiotic Prophylaxis): Receive standard one-time antibiotics before incision. Main Study Parameters/Endpoints: Compare the incidence of incisional and organ/space SSIs within six weeks post-surgery between Group A and Group B to determine if omitting antibiotics affects infection rates.

NCT Number	NCT06510452
Lead Sponsor	General Committee of Teaching Hospitals and Institutes, Egypt
Conditions	Antibiotic Reaction, Wound Infection Superficial, Wound Infection Deep, Bariatric Surgery Candidate, Complication,Postoperative
Enrollment	3,352 participants
Start Date	2024-10-01
Primary Completion	2025-12-01 (estimated)
Study Completion	2026-04-01 (estimated)
Updated on ClinicalTrials.gov	2024-07-31