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The goal of this clinical trial is to evaluate whether local subcutaneous administration of gentamicin reduces the incidence of surgical site infection (SSI) following elective cesarean section. The study will also assess the safety of local gentamicin administration. The main questions this study aims to answer are:
Researchers will compare women who receive local subcutaneous gentamicin at the surgical site in addition to standard antibiotic prophylaxis to women who receive standard antibiotic prophylaxis alone.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local subcutaneous gentamicin | Experimental | Participants undergoing elective cesarean section who receive standard systemic antibiotic prophylaxis according to institutional protocol plus a single local subcutaneous administration of gentamicin at the surgical site. |
|
| Local subcutaneous placebo (saline) | Placebo Comparator | Participants undergoing elective cesarean section who receive standard systemic antibiotic prophylaxis according to institutional protocol plus a single local subcutaneous administration of placebo (saline) at the surgical site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentamicin | Drug | Participants receive a single local subcutaneous administration of gentamicin at the surgical site during elective cesarean section, in addition to standard systemic antibiotic prophylaxis, to reduce postoperative surgical site infection. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite wound complication within 30 days after cesarean delivery | Occurrence of one or more postoperative wound complications within 30 days, including SSI, wound dehiscence, seroma requiring drainage, hematoma requiring intervention, wound-related antibiotic treatment, wound-related emergency department visit, or wound-related readmission. | within 30 days after cesarean section |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection within 30 days after cesarean delivery | 30 days after cesarean delivery |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility is limited to individuals of the female biological sex due to the nature of elective cesarean delivery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Galilee Hospital-Nahariya | Recruiting | Nahariya | Israel |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005839 | Gentamicins |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
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| Standard antibiotic prophylaxis | Drug | Participants receive standard systemic antibiotic prophylaxis according to institutional protocol. |
|
| Placebo (saline) | Other | Participants receive a single local subcutaneous administration of placebo (saline) at the surgical site during elective cesarean section, in addition to standard systemic antibiotic prophylaxis. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |