Viewing Study NCT06368102



Ignite Creation Date: 2024-05-06 @ 8:23 PM
Last Modification Date: 2024-10-26 @ 3:27 PM
Study NCT ID: NCT06368102
Status: RECRUITING
Last Update Posted: 2024-05-08
First Post: 2024-04-10

Brief Title: Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery
Sponsor: Uji Takeda Hospital
Organization: Uji Takeda Hospital

Study Overview

Official Title: Prophylactic Effects of Different Duration of Intravenous Ampicillin for Preventing Surgical Site Infection in Third Molar Surgery a Randomized Controlled Trial
Status: RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 US 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 49 million deaths related to drug-resistant organisms and 12 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 eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None