Surgical Site Infection (SSI)
Conditions
Keywords
Antibiotic Prophylaxis, Local Antibiotic Administration, Systemic Antibiotic Administration, Cefazolin, Gentamicin
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.
Interventions
DRUGCefazolin 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.
DRUGCefazolin
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
Sponsors
Lahore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Surgical Site Infection | Within 30 days after surgery | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORFaria Javed
Lahore General Hospital, Lahore
Outcome results
None listed