A Phase 3 interventional study of Cefazolin 1000 MG in Antibiotic Prophylaxis, Wound Infection and Groin Hernia, sponsored by University of Aleppo. Status unknown at 1 site in Syria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by University of Aleppo · Phase 3, Interventional, and Prevention
This study aims to investigate the impact of antibiotic prophylaxis on reducing wound infection rates following open repair of primary elective groin hernias in high-risk patients.
This study will be a randomized controlled trial involving high-risk patients undergoing open repair of primary elective groin hernias. Participants will be randomized into two groups: one receiving antibiotic prophylaxis and the other serving as the control group. The study will assess the incidence of wound infections postoperatively in both groups to determine the effectiveness of antibiotic prophylaxis in lowering infection rates.
388 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 301 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →University of Aleppo is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Patients with Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.
Drug: Cefazolin 1000 MG
Patients without Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.
* Medication: Cefazolin * Dosage: 1 gram * Administration Timing: A single dose will be administered preoperatively.
Overall Complication Rate
Overall complication rate; graded by the Clavien- Dindo complications classification system
Time frame: up to 30 days after the surgery.
Wound infection/ Surgical site infection
has been defined and classified as superficial incisional, deep incisional, and organ/ space\_ surgical site infection by the Centers for Disease Control and Prevention (CDC) (Anderson 2014; Ban 2017; Berríos-Torres 2017).
Time frame: up to 30 days after the surgery.
Mortality Rate
The measure of the number of deaths at the end of the study.
Time frame: up to 30 days after the surgery.
Hospital stay
In days: Number of days, patient in hospital since admission.
Time frame: up to 30 days after the surgery.
Other Adverse events
Any adverse events will be observed during the follow-up period.
Time frame: up to 30 days after the surgery.
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Aug 2025, 12 months after the start.
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This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cefazolin
University of Aleppo