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The goal of this clinical trial is to learn if the use of prophylactic antibiotics and antimicrobial-coated sutures can prevent surgical site infection in children undergoing open groin surgeries. The main question it aims to answer is:
• Does the use of intravenous prophylactic antibiotics or antimicrobial-coated sutures significantly reduce the occurrence of surgical site infection in children undergoing open groin surgeries?
Researchers will compare no antibiotic use to the use of intravenous prophylactic antibiotics, or antimicrobial-coated sutures to see if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures significantly reduces the occurrence of surgical site infection following open groin surgeries in children.
Participants will:
The aim of this clinical trial is to learn if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures can prevent surgical site infection in children undergoing open groin surgeries. The specific objectives are:
Researchers will compare no antibiotic use to the use of intravenous prophylactic antibiotics, or antimicrobial-coated sutures to see if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures significantly reduces the occurrence of surgical site infection following open groin surgeries in children.
It shall be a double blinded randomized controlled trial
Eligible Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Antibiotics arm | Placebo Comparator | Participants will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures |
|
| Intravenous prophylactic antibiotic arm | Active Comparator | Participants will have an intravenous prophylactic antibiotics given at the induction of anaesthesia and their wounds closed with non-coated sutures |
|
| Antimicrobial-coated suture arm | Experimental | Participants will have an intravenous placebo injection given at the induction of anaesthesia and their wounds closed with antimicrobial-coated sutures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antimicrobial-coated sutures | Device | Use of Antimicrobial-coated sutures to close all layers of the surgical wound following open paediatric groin surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | 30 days post operative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olawumi Olajide, M.B.Ch.B | Contact | +2348038696179 | yejola1212@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obafemi Awolowo University Teaching Hospitals Complex | Recruiting | Ile-Ife | Osun State | 220282 | Nigeria |
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| Intravenous Cefuroxime | Drug | Intravenous cefuroxime is given at the induction of anaesthesia |
|
| Placebo intravenous injection | Other | 0.2ml of Vitamin Bco injection + 9.8ml sterile water |
|
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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