Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06368102 |
| Other study ID # |
R6-03 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2024 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Uji Takeda Hospital |
| Contact |
Keita Kano, PhD |
| Phone |
+81774252500 |
| Email |
k-kano[@]takedahp.or.jp |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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 24 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.
