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

NCT07478874 | Completed

• 1 other identifier: LahoreGeneralH16
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Site Infection (SSI)

Keywords

Antibiotic Prophylaxis; Local Antibiotic Administration; Systemic Antibiotic Administration; Cefazolin; Gentamicin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Combined Local and Systemic Antibiotic Group

EXPERIMENTAL

Received intravenous cefazolin before surgery along with local gentamicin administered into the surgical wound intraoperatively.

Drug: Cefazolin plus Gentamicin

Systemic Antibiotic Alone Group

ACTIVE COMPARATOR

Received intravenous cefazolin before surgery without local gentamicin.

Drug: Cefazolin

Interventions

Cefazolin plus Gentamicin DRUG

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.

Combined Local and Systemic Antibiotic Group

Cefazolin DRUG

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

Systemic Antibiotic Alone Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefazolin; Gentamicins

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Faria Javed

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

PA (1)