Appropriate use of antibiotics in the perioperative period for jaw deformity related intervention research

UMIN ID: UMIN000054228

Registered date:23/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: jaw deformity
• Date of first enrollment: 2024/04/23
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

This study does not use any special test drugs or equipment. Cefazolin sodium for injection (CEZ) used, the route of administration is intravenous injection, and the single dose is 1 g. Single intraoperative administration group Single administration of CEZ 1g during maxillary osteotomy surgery Multiple administration during and after surgery group CEZ 1g administered during maxillary osteotomy surgery, CEZ 1g administered twice in the morning and evening until the second postoperative day (2g/day)
Multiple administration during and after surgery group CEZ 1g administered during maxillary osteotomy surgery, CEZ 1g administered twice in the morning and evening until the second postoperative day (2g/day)

Outcome(s)

• Primary Outcome: The following items on the 1st, 3rd, 7th, 14th, and 28th days after surgery Presence or absence of fever, presence or absence of cheek swelling, painless mouth opening, pain score (NRS), presence or absence of wound swelling, presence or absence of wound drainage.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: (Exclusion to affect effectiveness evaluation) (1) Patients with diabetes or blood diseases (2) Patients with inflammatory findings in the jawbone area, risk of infective endocarditis (IE), and risk of drug-induced osteonecrosis of the jaw (MRONJ) (3) Patients taking steroids or immunosuppressive drugs (4)Patients participating in other studies (Exclusion to affect safety assessment) (4) Patients with allergies to cephem antibiotics (5) Patients who are taking anticoagulants, antithrombotic drugs, etc. and are at risk of bleeding (6)Patients with renal dysfunction (7) Women who are pregnant, may become pregnant, within 28 days after giving birth, or are breastfeeding. (Exclusion from the perspective of risk/benefit balance) (8) Patients who are judged to be difficult to participate in research due to psychosis or psychiatric symptoms

Related Information

• Primary Sponsor: Tohoku University Graduate School of Dentistry
• Source(s) of Monetary Support: Nothing