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. 2017 Jun 18;2017(6):CD004637. doi: 10.1002/14651858.CD004637.pub2

Chongsomchai 2002.

Methods Design: randomised double‐blinded
No. eligible: 330
No. randomised: 330
No. analysed: 321
Drop‐outs/withdrawals: 9 did not undergo hysterectomy as planned (3 in cefazolin group, 4 in ampicillin group, 2 in placebo group)
Years of recruitment: 1997 to 1999
Setting: 2 regional hospitals in Thailand
Participants Inclusion criteria: scheduled for elective total abdominal hysterectomy
 Exclusion criteria: preoperative fever or infection, allergic to ampicillin or cefazolin, had received antibiotics within 48 hours of surgery, emergency cases, pregnancy‐related cases
 Age: mean 43 years
 Type of hysterectomy: abdominal
Interventions Treatment 1: 1 gram ampicillin (penicillin)
Treatment 2: 1 gram cefazolin (first‐generation cephalosporin)
Control: placebo
Route: IV
Single/multiple doses: single
Timing of doses: 30 minutes before surgery
Outcomes Postoperative infection, early and late
Abdominal wound infection
Urinary tract infection
Pelvic infection
Adverse effects (narrative data only)
Other serious infection
Postoperative fever
Asymptomatic infection
Follow‐up: 4 weeks
Funding National Research Council, Thailand
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Computer‐generated randomization"
Allocation concealment (selection bias) Low risk "Opaque sealed envelopes" ‐ probably done
Blinding (performance bias and detection bias) 
 All outcomes Low risk "Patients, their gynaecologists, all investigators and evaluators were blinded to the random allocation throughout the study"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Proportions of withdrawals/losses to follow‐up similar in treatment groups and < 10% in each group
Selective reporting (reporting bias) Low risk All reported outcomes were prespecified in the methods section
Other bias Low risk Baseline demographic characteristics similar between treatment groups