Inguinal HerniaNCT07346742
Prevention of Surgical Site Infection in Open Paediatric Groin Surgeries Using Intravenous Prophylactic Antibiotics and Antimicrobial-coated Sutures
A study testing Antimicrobial-coated sutures and Intravenous Cefuroxime in people with Inguinal Hernia and Hydroceles, run by Olawumi Olajide at 1 site in Nigeria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Inguinal Hernia, Hydroceles, Surgical Site Infection
- What is being tested?
- Antimicrobial-coated sutures and Intravenous Cefuroxime
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteNigeria
- Study dates
- 9 Mar 2025to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients with clinical conditions requiring daycase open groin surgery
Who cannot join
- Re-operations
- Immunocompromised patients
- Malnourished patients
- Complicated groin pathologies e,g obstructed inguinal hernia
- History of antibiotic usage in the last seven days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria1 site, 1 recruiting
- Recruiting
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Osun State, 220282
Olawumi Olajide, M.B.Ch.B, +2348038696179, yejola1212@gmail.com
Olawumi Olajide, M.B.Ch.B
About this study
Official title: Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures in Preventing Surgical Site Infection in Open Paediatric Groin Surgeries: A 3-arm Randomized Controlled Trial
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?
Read more
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.
Read the detailed 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.
- Conditions
- Inguinal Hernia, Hydroceles, Surgical Site Infection
- Being tested
- Antimicrobial-coated sutures, Intravenous Cefuroxime, Placebo intravenous injection
- Keywords
- Paediatric groin surgeries, Intravenous prophylactic antibiotics, Antimicrobial-coated sutures, Double blinded randomized controlled trial
- Medical subject headings
- Hernia, Inguinal, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial-coated suturesDevice
Use of Antimicrobial-coated sutures to close all layers of the surgical wound following open paediatric groin surgery
Intravenous CefuroximeDrug
Intravenous cefuroxime is given at the induction of anaesthesia
Placebo intravenous injectionOther
0.2ml of Vitamin Bco injection + 9.8ml sterile water
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Placebo intravenous injection |
| 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 Receives: Drug: Intravenous Cefuroxime |
| 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 Receives: Device: Antimicrobial-coated sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Measured: 30 days post operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start9 Mar 2025
- Primary completion27 Feb 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olawumi Olajide
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olawumi Olajide, Obafemi Awolowo University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346742
- Sponsor's protocol ID
- ERC/2024/08/11
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures in Preventing Surgical Site Infection in Open Paediatric Groin Surgeries: A 3-arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07346742
- Acronym / sponsor ID
- ERC/2024/08/11
- Conditions
- Inguinal Hernia, Hydroceles, Surgical Site Infection
- Keywords
- Paediatric groin surgeries, Intravenous prophylactic antibiotics, Antimicrobial-coated sutures, Double blinded randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Olawumi OlajideUniversity, hospital or other
- Study start
- 9 Mar 2025 (actual)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Antibiotics arm | Placebo comparator | Other: Placebo intravenous injectionParticipants 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 | Drug: Intravenous CefuroximeParticipants 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 | Device: Antimicrobial-coated suturesParticipants will have an intravenous placebo injection given at the induction of anaesthesia and their wounds closed with antimicrobial-coated sutures |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients with clinical conditions requiring daycase open groin surgery
Key exclusion criteria (5 listed)
- Re-operations
- Immunocompromised patients
- Malnourished patients
- Complicated groin pathologies e,g obstructed inguinal hernia
- History of antibiotic usage in the last seven days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antimicrobial-coated suturesUse of Antimicrobial-coated sutures to close all layers of the surgical wound following open paediatric groin surgery | Device | Antimicrobial-coated suture arm |
| Intravenous CefuroximeIntravenous cefuroxime is given at the induction of anaesthesia | Drug | Intravenous prophylactic antibiotic arm |
| Placebo intravenous injection0.2ml of Vitamin Bco injection + 9.8ml sterile water | Other | No Antibiotics arm |
Primary outcome
Surgical site infection
Time frame: 30 days post operative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial-coated sutures and Intravenous Cefuroxime in people with Inguinal Hernia and Hydroceles, run by Olawumi Olajide at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olawumi Olajide, M.B.Ch.B (+2348038696179, yejola1212@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 30 days post operative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.