Prophylactic Antibiotics in Groin Hernioplasty

NCT ID: NCT07111702

Last Updated: 2025-08-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-05-30

Brief Summary

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The role of prophylactic antibiotics in preventing surgical site infections (SSI) for clean procedures like groin hernia repair remains controversial. This study aimed to evaluate the association between antibiotic prophylaxis and SSI rates in a real-world clinical setting and to identify independent risk factors for SSI. The study prospectively followed 100 male patients undergoing elective open groin hernioplasty. Patients were categorized based on the surgeon's decision into two groups: those who received a single dose of intravenous cefazolin (Antibiotic Group) and those who did not (No Antibiotic Group). The main outcome was the rate of SSI within 30 days of surgery.

Detailed Description

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Conditions

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Surgical Site Infection Groin Hernia Hernioplasty

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Antibiotic Group

Patients received a single intravenous dose of cefazolin (2 g) 30-60 min prior to skin incision.

Group Type EXPERIMENTAL

Cefazolin

Intervention Type DRUG

A single 2g intravenous dose administered once before surgery.

No Antibiotic Group

Patients did not receive antibiotic prophylaxis.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cefazolin

A single 2g intravenous dose administered once before surgery.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients (aged 17-80 years) undergoing primary open groin hernioplasty.
* Provided written informed consent.

Exclusion Criteria

* Recurrent, emergency, or complicated (e.g., incarcerated, strangulated) hernias.
* Laparoscopic repairs.
* Known immunosuppression, ongoing antibiotic therapy, or a known allergy to cefazolin.
* Refusal to participate.
Minimum Eligible Age

17 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Gumhori Teaching Hospital

UNKNOWN

Sponsor Role collaborator

Sana'a University

OTHER

Sponsor Role lead

Responsible Party

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Haitham Mohammed Jowah

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed Mohammed Gilan, Asssociate Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine and Health Sciences, Sana'a University

Locations

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Al-Gumhori Teaching Hospital

Sanaa, , Yemen

Site Status

Countries

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Yemen

Other Identifiers

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SU-Hernia-001

Identifier Type: -

Identifier Source: org_study_id

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