Antibiotics in oral cancer

Phase 3

Conditions: Health Condition 1: null- Patients with operable oral cancer

Registration Number: CTRI/2015/05/005790

Lead Sponsor: Tata Memorial Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 1360

Inclusion Criteria

1.Age 18 years or older

2.ECOG performance status of 0 or 1

3.Biopsy proven squamous cell carcinoma of oral cavity

4.Patients must have normal organ and marrow function: absolute neutrophil count (ANC) >= 1,500/mm3

5.Willing and able to comply with all study requirements, including treatment (Surgery and reconstruction), timing and/or nature of required assessments.

6.Signed, written, informed consent.

Exclusion Criteria

1.Patients with known hypersensitivity to Cephalosporins/Penicillins

2.Patients with immunosuppresion

3.Significant renal dysfunction requiring dose reduction of antibiotics

4.Documented preoperative surgical field infection (Patients with fungating wounds may be included, provided there is no active infection at the incision site i.e either frank erythema or pus from wound or as per treating cliniciansâ?? opinion.)

5.Known colonisation with methicillin resistant Staphylococcus aureus or vancomycin resistant Enterococcus

6.Patients with oral cancer undergoing clean surgery (e.g. neck dissection alone)

7.Pregnancy or lactation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of Surgical Site infection <br/ ><br>Surgical site infection will be defined by Johnsonâ??s criteria28 (Grade 4 or more ) (Table 3), or documentation by the investigator as presence of SSI or restart of antibiotic for SSI. It will be documented as Yes/ No. <br/ ><br>Timepoint: Will be assessed on postoperative day3, 5 and at discharge and upto 30 days or development of SSI whichever is earlier <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Rate of surgical site infection <br/ ><br>The rate of surgical site infection will be measured as the no of cases of SSI in each group divided by the total number of subjects in each group <br/ ><br>Timepoint: After end of 30 days of last patient recruited