Prevention of Surgical Site Infection in Open Paediatric Groin Surgeries Using Intravenous Prophylactic Antibiotics and Antimicrobial-coated Sutures

Olawumi Olajide

Status: Enrolling

Conditions: Hydroceles; Surgical Site Infection; Inguinal Hernia

Treatments: Drug: Intravenous Cefuroxime; Device: Antimicrobial-coated sutures; Other: Placebo intravenous injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07346742

ERC/2024/08/11

Details and patient eligibility

About

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:

• Undergo open groin surgery with either the use of intravenous prophylactic antibiotic or antimicrobial-coated sutures or without antibiotic use
• Visit the clinic on postoperative days 5, 13 and 30 for review of the surgical wounds for any sign of infection.

Full description

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:

• To determine the rate of surgical site infection in paediatric groin surgeries without antibiotics
• To determine the rate of surgical site infection in paediatric groin surgeries with the use of intravenous prophylactic antibiotics
• To determine the rate of surgical site infection in paediatric groin surgeries with the use of antimicrobial-coated sutures.
• To compare the rates of surgical site infection in paediatric groin surgeries without antibiotics, with the use of intravenous prophylactic antibiotics and use of antimicrobial-coated sutures

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:

• On the morning of the surgery be randomly assigned to either group A or B or C
• Participants in group A will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures
• Participants in group B will have intravenous prophylactic antibiotic given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures
• Participants in group C will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using antimicrobial-coated sutures
• Visit the clinic on postoperative days 5, 13 and 30 for review of the surgical wounds for any sign of infection following the CDC guidelines.

Enrollment: 174 estimated patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with clinical conditions requiring daycase open groin surgery

Exclusion criteria

1. Re-operations
2. Immunocompromised patients
3. Malnourished patients
4. Complicated groin pathologies e,g obstructed inguinal hernia
5. History of antibiotic usage in the last seven days

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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174 participants in 3 patient groups, including a placebo group

No Antibiotics arm

Placebo Comparator group

Description:

Participants will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures

Treatment:

Other: Placebo intravenous injection

Intravenous prophylactic antibiotic arm

Active Comparator group

Description:

Participants will have an intravenous prophylactic antibiotics given at the induction of anaesthesia and their wounds closed with non-coated sutures

Treatment:

Drug: Intravenous Cefuroxime

Antimicrobial-coated suture arm

Experimental group

Description:

Participants will have an intravenous placebo injection given at the induction of anaesthesia and their wounds closed with antimicrobial-coated sutures

Treatment:

Device: Antimicrobial-coated sutures