Antibiotic ProphylaxisPhase 3NCT06576154
The Role of Antibiotic Prophylaxis in Lowering Wound Infection Rates Post-Open Repair of Primary Elective Groin Hernias in High-Risk Patients
A Phase 3 study testing Cefazolin 1000 MG in people with Antibiotic Prophylaxis and Wound Infection, run by University of Aleppo at 1 site in Syria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Prophylaxis, Wound Infection, Groin Hernia
- What is being tested?
- Cefazolin 1000 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSyria
- Study dates
- 1 Aug 2024to 1 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the study.
- Elderly patients aged over 60 years.
- Patients with Diabetes.
- Or obese patients with a BMI greater than 35.
- Or immunocompromised patients.
- Or American Society of Anesthesiologists (ASA) physical status classification 2 or more, with a history of more than 10 years.
Who cannot join
- Non-cooperative patients for regular follow-up.
- Therapeutic Indication for.
Trial locations and contacts
1 site in 1 country.
Syria1 site, 1 recruiting
- Recruiting
Aleppo University Hospital
Aleppo
Ahmad Y Arnaout, M.D, +963967306577, yamen.arnout@gmail.com
Mohammad H Nabhan, M.D
About this study
Official title: The Role of Antibiotic Prophylaxis in Lowering Wound Infection Rates Post-Open Repair of Primary Elective Groin Hernias in High-Risk Patients: A Randomized Control Trial.
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.
Read the detailed description
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.
- Conditions
- Antibiotic Prophylaxis, Wound Infection, Groin Hernia
- Being tested
- Cefazolin 1000 MG
- Keywords
- Groin hernia, Postoperative complications, Wound infection, Surgical site infection, High-risk patients
- Medical subject headings
- Wound Infection, Hernia, Inguinal, Postoperative Complications, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin 1000 MGDrug
- Medication: Cefazolin
- Dosage: 1 gram
- Administration Timing: A single dose will be administered preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis antibiotics Group | Experimental | Patients with Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients. Receives: Drug: Cefazolin 1000 MG |
| Non-antibiotics Group | No intervention | Patients without Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Complication Rate
Overall complication rate; graded by the Clavien- Dindo complications classification system
Measured: 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).
Measured: up to 30 days after the surgery.
Secondary outcomes (2)
Mortality Rate
The measure of the number of deaths at the end of the study.
Measured: up to 30 days after the surgery.
Hospital stay
In days: Number of days, patient in hospital since admission.
Measured: up to 30 days after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Aug 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aleppo
- Sponsor type
- University, hospital or other
- Collaborators
- Aleppo University Hospital Resident Team
- Responsible party
- Principal investigator, Ahmad Yamen Arnaout, University of Aleppo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576154
- Sponsor's protocol ID
- AP-GH-OE-2023-HR
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Antibiotic Prophylaxis in Lowering Wound Infection Rates Post-Open Repair of Primary Elective Groin Hernias in High-Risk Patients: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT06576154
- Acronym / sponsor ID
- AP-GH-OE-2023-HR
- Conditions
- Antibiotic Prophylaxis, Wound Infection, Groin Hernia
- Keywords
- Groin hernia, Postoperative complications, Wound infection, Surgical site infection, High-risk patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AleppoUniversity, hospital or other
- Collaborators
- Aleppo University Hospital Resident Team
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis antibiotics Group | Experimental | Drug: Cefazolin 1000 MGPatients with Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients. |
| Non-antibiotics Group | No intervention | –Patients without Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteer to participate in the study.
- Elderly patients aged over 60 years.
- Patients with Diabetes.
- Or obese patients with a BMI greater than 35.
- Or immunocompromised patients.
Key exclusion criteria (2 listed)
- Non-cooperative patients for regular follow-up.
- Therapeutic Indication for.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefazolin 1000 MG* Medication: Cefazolin * Dosage: 1 gram * Administration Timing: A single dose will be administered preoperatively. | Drug | Prophylaxis antibiotics Group |
Primary outcome
Overall Complication Rate
Time frame: up to 30 days after the surgery.
Overall complication rate; graded by the Clavien- Dindo complications classification system
Wound infection/ Surgical site infection
Time frame: up to 30 days after the surgery.
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).
2 secondary outcomes
Mortality Rate
Time frame: up to 30 days after the surgery.
Hospital stay
Time frame: up to 30 days after the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefazolin 1000 MG in people with Antibiotic Prophylaxis and Wound Infection, run by University of Aleppo at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad H Nabhan, M.D (+963956768862, m.hassannabhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Complication Rate (time frame: up to 30 days after the surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.