An interventional study of Cefazolin plus Gentamicin and Cefazolin in Surgical Site Infection (SSI), sponsored by Lahore General Hospital. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Lahore General Hospital · Not applicable, Interventional, and Treatment
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.
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's enrollment of 284 is above the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Lahore General Hospital is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Received intravenous cefazolin before surgery along with local gentamicin administered into the surgical wound intraoperatively.
Drug: Cefazolin plus Gentamicin
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, 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.
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
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.
Time frame: Within 30 days after surgery
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Lahore General Hospital