Surgical Site InfectionPhase 4NCT06368102
Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery
A Phase 4 study testing Ampicillin in people with Surgical Site Infection, run by Uji Takeda Hospital at 1 site in Japan.
Trial summary
The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Ampicillin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteJapan
- Study dates
- 2 May 2024to 1 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum age of 20 years
- American Society of Anesthesiologists (ASA) physical status of 1
- Planned extraction of bilateral mandibular third molar with the necessity of bone removal based on panoramic radiography in an inpatient setting under IV sedation
- Agreement to follow the study protocol
Who cannot join
- Pregnancy or suspicion of pregnancy
- Allergy and/or contraindication to ampicillin
- History of a known SSI risk factors, such as diabetes, steroid or immunosuppressant use, and endocarditis
- Receiving any antibiotic therapy
- Active infection of the third molars with pus, edema, and trismus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Effects of Different Duration of Intravenous Ampicillin for Preventing Surgical Site Infection in Third Molar Surgery: a Randomized Controlled Trial
The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration.
Read the detailed description
In recent years, the increase in drug-resistant bacteria and associated infections has become one of the major issues in the international community as adverse events associated with the inappropriate use of antimicrobial agents. Although the frequency and percentage of inappropriate use is currently unknown, it has been shown that at least 30% of antimicrobials prescribed in the U.S. are inappropriately used. If no action is taken against inappropriate antimicrobial use, it is estimated that 10 million people will die annually worldwide from drug-resistant organisms by 2050, with an estimated 4.9 million deaths related to drug-resistant organisms and 1.2 million deaths due to drug-resistant organisms already estimated for 2019. In addition, while the development of new antimicrobial agents has declined since the 1980s, the threat of new drug-resistant organisms, especially in hospitals, has increased, and if antimicrobial agents are not used appropriately, there is concern that there will be no effective antimicrobial agents available to treat infections in the future. It is important to avoid such situations by using antimicrobial agents, which are a limited resource, appropriately at this stage, and appropriate use of antimicrobial agents is necessary to prevent drug resistance (Antimicrobial Resistance: AMR).
Third molar extraction is the most commonly performed procedure in oral and maxillofacial surgery. One of the main complications after third molar extractions is surgical site infection (SSIs), which is reported to manifest as swelling, pain, abscess, and fever. According to a Cochrane review of randomized controlled trials, the risk of SSIs after third molar extraction in physically fit young patients is about 10%, but in patients with low immunity before extraction, the risk increases up to 25%. Prophylactic administration of antimicrobial agents has an important role in preventing SSIs. However, the efficacy of antimicrobial prophylaxis against SSIs in third molar extractions is controversial. While some studies have reported that antimicrobials are effective in preventing SSIs after third molar extraction, others have reported that they are not.
Guidelines for third molar extraction vary widely in the duration of antimicrobial administration (e.g., Japanese guidelines state a single dose to within 48 hours). In clinical practice, the final decision lies with the surgeon, but this difference in dosing period is a source of confusion. If the duration of administration could be shortened without increasing SSIs, it would contribute to the current presentation of AMR. Therefore, the purpose of this study is to examine the effect of different durations and doses of penicillins, which are considered first-line drugs after third molar surgery, on the prevention of SSIs.
- Conditions
- Surgical Site Infection
- Being tested
- Ampicillin
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmpicillinDrug
Total 2g vs 3g
| Study group | Role | What they receive |
|---|---|---|
| 1day-group | Experimental | Participants will receive 1g of IV ampicillin before surgery and 1 time after surgery on the day of surgery (total 2g) Receives: Drug: Ampicillin |
| 2day-group | Experimental | Participants will receive 1g of IV ampicillin before surgery and 2 times after surgery up to the next day (total 3g) Receives: Drug: Ampicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of surgical site infection
is evaluated based on the guidelines by the Center for Disease Control and Prevention (CDC) and Clavien-Dindo classification system: within 30 days postoperatively, drainage from a surgical wound or abscess, requiring treatment with antimicrobial agents.
Measured: 30 days
Secondary outcomes (1)
Occurrence of alveolar osteitis
is evaluated based on the postoperative pain within and around the extraction site with increasing severity accompanied by partially or completely collapsed clots in the alveolar fossa, and the presence of halitosis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start2 May 2024
- Primary completion1 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uji Takeda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keita Kano, PhD, Study chair, Uji Takeda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368102
- Sponsor's protocol ID
- R6-03
- Status last verified
- Sep 2025
- First submitted
- 10 Apr 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Effects of Different Duration of Intravenous Ampicillin for Preventing Surgical Site Infection in Third Molar Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06368102
- Acronym / sponsor ID
- R6-03
- Conditions
- Surgical Site Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Uji Takeda HospitalUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 16 Apr 2024 (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 purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration.
Detailed description
In recent years, the increase in drug-resistant bacteria and associated infections has become one of the major issues in the international community as adverse events associated with the inappropriate use of antimicrobial agents. Although the frequency and percentage of inappropriate use is currently unknown, it has been shown that at least 30% of antimicrobials prescribed in the U.S. are inappropriately used. If no action is taken against inappropriate antimicrobial use, it is estimated that 10 million people will die annually worldwide from drug-resistant organisms by 2050, with an estimated 4.9 million deaths related to drug-resistant organisms and 1.2 million deaths due to drug-resistant organisms already estimated for 2019. In addition, while the development of new antimicrobial agents has declined since the 1980s, the threat of new drug-resistant organisms, especially in hospitals, has increased, and if antimicrobial agents are not used appropriately, there is concern that there will be no effective antimicrobial agents available to treat infections in the future. It is important to avoid such situations by using antimicrobial agents, which are a limited resource, appropriately at this stage, and appropriate use of antimicrobial agents is necessary to prevent drug resistance (Antimicrobial Resistance: AMR).
Third molar extraction is the most commonly performed procedure in oral and maxillofacial surgery. One of the main complications after third molar extractions is surgical site infection (SSIs), which is reported to manifest as swelling, pain, abscess, and fever. According to a Cochrane review of randomized controlled trials, the risk of SSIs after third molar extraction in physically fit young patients is about 10%, but in patients with low immunity before extraction, the risk increases up to 25%. Prophylactic administration of antimicrobial agents has an important role in preventing SSIs. However, the efficacy of antimicrobial prophylaxis against SSIs in third molar extractions is controversial. While some studies have reported that antimicrobials are effective in preventing SSIs after third molar extraction, others have reported that they are not.
Guidelines for third molar extraction vary widely in the duration of antimicrobial administration (e.g., Japanese guidelines state a single dose to within 48 hours). In clinical practice, the final decision lies with the surgeon, but this difference in dosing period is a source of confusion. If the duration of administration could be shortened without increasing SSIs, it would contribute to the current presentation of AMR. Therefore, the purpose of this study is to examine the effect of different durations and doses of penicillins, which are considered first-line drugs after third molar surgery, on the prevention of SSIs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1day-group | Experimental | Drug: AmpicillinParticipants will receive 1g of IV ampicillin before surgery and 1 time after surgery on the day of surgery (total 2g) |
| 2day-group | Experimental | Drug: AmpicillinParticipants will receive 1g of IV ampicillin before surgery and 2 times after surgery up to the next day (total 3g) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum age of 20 years
- American Society of Anesthesiologists (ASA) physical status of 1
- Planned extraction of bilateral mandibular third molar with the necessity of bone removal based on panoramic radiography in an inpatient setting under IV sedation
- Agreement to follow the study protocol
Key exclusion criteria (5 listed)
- Pregnancy or suspicion of pregnancy
- Allergy and/or contraindication to ampicillin
- History of a known SSI risk factors, such as diabetes, steroid or immunosuppressant use, and endocarditis
- Receiving any antibiotic therapy
- Active infection of the third molars with pus, edema, and trismus
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 |
|---|---|---|
| AmpicillinTotal 2g vs 3g | Drug | 1day-group, 2day-group |
Primary outcome
Occurrence of surgical site infection
Time frame: 30 days
is evaluated based on the guidelines by the Center for Disease Control and Prevention (CDC) and Clavien-Dindo classification system: within 30 days postoperatively, drainage from a surgical wound or abscess, requiring treatment with antimicrobial agents.
1 secondary outcome
Occurrence of alveolar osteitis
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
Related trials for Surgical Site Infection
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)
RecruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
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. This study is not recruiting at the moment.
Keita Kano, PhD study chair
Uji Takeda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ampicillin in people with Surgical Site Infection, run by Uji Takeda Hospital at 1 site in Japan.
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 4 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: finished, as of the sponsor's last update on 24 Sep 2025. 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 Japan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of surgical site infection (time frame: 30 days). 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 24 Sep 2025.