Prophylaxis Against Surgical Site Infections Using Local as Well as Systemic Antibiotic

Surgical site infections were defined as infections that developed in the area of an operation within 30 days after surgery. They remained a common problem after surgery and could increase pain, delay wound healing, prolong hospital stay, increase treatment costs, and raise the risk of further complications. Although systemic antibiotics were routinely used before surgery to reduce this risk, it was not yet clear whether adding a local antibiotic directly into the wound provided better protection than systemic antibiotics alone.

This randomized controlled trial was planned to compare two methods of antibiotic prophylaxis in adult patients undergoing clean or clean-contaminated elective surgery at Surgical Unit I, Lahore General Hospital, Lahore. One group received the standard prophylactic systemic antibiotic cefazolin intravenously before surgery. The other group received the same systemic antibiotic together with local gentamicin applied into the surgical wound during the operation. The purpose of the study was to determine whether the combined use of local and systemic antibiotics reduced the frequency of surgical site infection more effectively than systemic antibiotic prophylaxis alone.

The study included adult patients of either gender who were able to provide informed consent and were undergoing elective procedures such as hernia repair or laparoscopic cholecystectomy. Patients with allergy to cefazolin or gentamicin, prolonged prior antibiotic use, diabetes mellitus, previous surgical site infection, immunocompromised state, coronary artery disease, chronic obstructive pulmonary disease, or chronic kidney disease were excluded.

Participants were followed during hospital stay and were then monitored for 30 days after surgery for evidence of wound infection. Surgical site infection was assessed using the Southampton wound scoring system, and any grade other than grade 0 was considered infection according to the study definition.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection (SSI)
• Intervention / Treatment: Drug: Cefazolin plus Gentamicin; Drug: Cefazolin

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Lahore General Hospital, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged more than 18 years
• Individuals of either gender
• Patients able to provide informed consent
• Patients undergoing clean or clean-contaminated elective surgeries, such as hernia repair or laparoscopic cholecystectomy

Exclusion Criteria:

• Allergy to cefazolin or gentamicin
• Use of antibiotics for more than one week before surgery
• Diabetes mellitus
• Previous surgical site infection
• Immunocompromised state
• Coronary artery disease
• Chronic obstructive pulmonary disease
• Chronic kidney disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Local and Systemic Antibiotic Group; Received intravenous cefazolin before surgery along with local gentamicin administered into the surgical wound intraoperatively.	Drug: Cefazolin plus Gentamicin; Participants received intravenous cefazolin 1 gram administered 30 to 60 minutes before surgical incision as prophylaxis, along with local gentamicin 80 mg/2 mL injected into the surgical wound once during the operation. Additional intraoperative doses of cefazolin were administered depending on the duration of surgery.
Active Comparator: Systemic Antibiotic Alone Group; Received intravenous cefazolin before surgery without local gentamicin.	Drug: Cefazolin; Participants received intravenous cefazolin 1 gram administered 30 to 60 minutes before surgical incision as prophylaxis. Additional intraoperative doses were administered depending on the duration of surgery. No local antibiotic was given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Surgical Site Infection	Surgical site infection was the primary outcome measure of the study. It was defined as any wound infection occurring at the surgical site within 30 days after surgery. Assessment was performed using the Southampton wound scoring system, and any grade other than grade 0 was considered a surgical site infection according to the study protocol.	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Lahore General Hospital
• Investigators: Principal Investigator: Faria Javed, Lahore General Hospital, Lahore

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Gentamicin; Antibiotic Prophylaxis; Cefazolin; Local Antibiotic Administration; Systemic Antibiotic Administration
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates; Glycosides; Amides; Aminoglycosides; beta-Lactams; Lactams; Cephalosporins; Thiazines; Cefazolin; Gentamicins
• Other Study ID Numbers: LahoreGeneralH16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No