Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Local and Systemic Antibiotic Group | Experimental | Received intravenous cefazolin before surgery along with local gentamicin administered into the surgical wound intraoperatively. |
|
| Systemic Antibiotic Alone Group | Active Comparator | Received intravenous cefazolin before surgery without local gentamicin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Faria Javed | Lahore General Hospital, Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahore General Hospital, Lahore | Lahore | Punjab Province | 54000 | Pakistan |
Not provided
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |