The Role of Antibiotic Prophylaxis in Lowering Wound Infection Rates Post-Open Repair of Primary Elective Groin Hernias in High-Risk Patients

NCT ID: NCT06576154

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-09-01

Brief Summary

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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

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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

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Antibiotic Prophylaxis Wound Infection Groin Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Prophylaxis antibiotics Group

Patients with Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.

Group Type EXPERIMENTAL

Cefazolin 1000 MG

Intervention Type DRUG

* Medication: Cefazolin
* Dosage: 1 gram
* Administration Timing: A single dose will be administered preoperatively.

Non-antibiotics Group

Patients without Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cefazolin 1000 MG

* Medication: Cefazolin
* Dosage: 1 gram
* Administration Timing: A single dose will be administered preoperatively.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Non-cooperative patients for regular follow-up.
* Therapeutic Indication for.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aleppo University Hospital Resident Team

UNKNOWN

Sponsor Role collaborator

University of Aleppo

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Yamen Arnaout

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aleppo University Hospital

Aleppo, , Syria

Site Status RECRUITING

Countries

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Syria

Central Contacts

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Mohammad H Nabhan, M.D

Role: CONTACT

+963956768862

Facility Contacts

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Ahmad Y Arnaout, M.D

Role: primary

+963967306577

Other Identifiers

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AP-GH-OE-2023-HR

Identifier Type: -

Identifier Source: org_study_id

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