2000 mg of Cefazolin
Drugreceive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
Other names: Kefzol
NCT Number: NCT06510452
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Madina Women's Hospital, Alexandria, Egypt
Nature and Extent of the Burden and Risks:
Rationale:
Risk Assessment:
Group Relatedness:
Comparing groups with and without antibiotics provides evi-dence-based insights into the safety of modifying standard practices to optimize health outcomes and resource use.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
° Patients must be older than 18 and meet the eligibility criteria for MBS as outlined by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and the Dutch Federation of Medical Specialists for the surgical treatment of obesity.
Exclusion criteria
receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
Other names: Kefzol
receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
Other names: Flagyl
receive 100 ml NACL0.9% without any antibiotics in it.
Other names: Saline
Time frame: until 6 weeks post operative
Aims to evaluate the non-inferiority of foregoing antibiotic prophylaxis in MBS. The study will compare postoperative outcomes between two groups: Group A, which will not receive antibiotic prophylaxis, and Group B, which will receive standard care including a one-time administration of antibiotics, to test the hypothesis that omitting antibiotic prophylaxis does not significantly increase the incidence of postoperative complications, in particular wound infections.
General Committee of Teaching Hospitals and Institutes, Egypt
Other Gov
Efficacy of Antibiotic Prophylaxis in Metabolic Bariatric Surgery: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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