Table 3.
Methods and outcome definitions used in individual trials
| Study | Allocation generation | Allocation concealment | Blinding* | Intention to treat analysis | Secondary outcomes evaluated and definitions | Resistance development/surveillance cultures† |
|---|---|---|---|---|---|---|
| Alexander 198251 | Adequate (random choice of envelopes) | Adequate (central pharmacist) | DB (placebo used, only pharmacist aware of treatment assignment) | Yes | Wound infection (discharge of pus from graft associated with graft loss); P aeruginosa and S aureus infections; hospital stay | NA. No surveillance |
| Alexander 198450 | Unclear (not stated) | Unclear (not stated) | Open (treatment and control patients placed in different wards) | Yes | Bacteraemia; wound infection | NA. Wound and blood surveillance |
| Barret 200152 | Adequate (random number chart) | Adequate (central pharmacy) | DB (placebo used, only pharmacist aware of treatment assignment) | Yes | Pneumonia (by CDC criteria or similar66); systemic fungal infection; hospital stay | NA. Wound, sputum, urine, blood, gastric aspirates, and stool surveillance |
| De la Cal 200553 | Unclear (not stated) | Adequate (central, pharmacy and kept in sealed envelopes) | DB (placebo used, only pharmacist aware of treatment assignment) + evaluator blinded | No | Pneumonia and bacteraemia (CDC criteria66); wound infection (according to previously proposed criteria67); candidaemia; P aeruginosa and S aureus infections; hospital stay | Unrelated; ventilator associated pneumonia or bacteraemia caused by MRSA. Wound, throat, rectal surveillance |
| Desai 199154 | Unclear (not stated) | Unclear (not stated) | Open | Yes | Wound infection (chondritis, defined); hospital stay | Related; chondritis caused by gentamicin-resistant bacteria. Wound surveillance |
| Deutch 199055 | Inadequate (chronological alternation) | Inadequate (chronological alternation) | Open | Yes for mortality; no for secondary outcomes | Wound and fungal infection (positive wound cultures); bacteraemia; P aeruginosa and S aureus infections; hospital stay | NA. Wound surveillance |
| Durtschi 198256 | Unclear (not stated) | Unclear (not stated) | DB (placebo used) | Yes | Wound infection (sepsis and warm, spreading, painful cutaneous erythema); bacteraemia; P aeruginosa, S aureus, and fungal infections; hospital stay | Unrelated; infections caused by gentamicin-resistant bacteria. Wound, rectal surveillance |
| Kimura 199857 | Unclear (not stated) | Adequate (central pharmacy) | DB | Yes | Pneumonia (by CDC criteria66); P aeruginosa and S aureus infections | Unrelated; MRSA infections. No surveillance |
| Levine 197865 | Unclear (not stated) | Unclear (not stated) | Single or DB (placebo inhalations used) | Yes | Pneumonia (pulmonary infiltrate); bacteraemia; P aeruginosa infections | NA. Blood surveillance |
| Livingston 199021 | Adequate (cards shuffled at assignment) | Adequate (cards placed in sealed envelopes) | Open | Yes | Wound infection (>10% graft loss and >105 organisms/g tissue, both in non-adherent graft and recipient site; candida wound infections; hospital stay | Unrelated; MRSA infections. Wound surveillance |
| Lowbury 196858 | Inadequate (alternation) | Inadequate (alternation) | Open (no placebo, no blinding described) | Yes | P aeruginosa and S aureus infections | Related; infections caused by gentamicin-resistant bacteria. Wound surveillance |
| Munster 198959 | Inadequate (randomised by hospital number) | Inadequate (randomised by hospital number) | Open (no placebo, no blinding described) | Yes | No secondary outcome | NA. No surveillance |
| Piel 198560 | Unclear (not stated) | Unclear (not stated) | Open (intervention listed on bedside flow chart) | Yes | Bacteraemia | NA. Wound and blood surveillance |
| Ramos 200861 | Unclear (not stated) | Adequate (sealed envelopes) | Evaluator | Yes | Wound infection (graft loss with swelling, erythema, increased temperature, tenderness or purulent discharge) | NA. Wound surveillance |
| Rodgers 199762 | Adequate (table of random numbers) | Unclear (not stated) | DB (placebo used, only pharmacist and one un-blinded investigator in the operating room aware of treatment assignment) + evaluator | Yes | Wound infection (clinical indication of infection with positive quantitative skin, wound biopsy, or blood cultures); candida wound infection; bacteraemia; P aeruginosa and S aureus infections | NA. Wound and blood surveillance |
| Steer 199763 | Unclear (not stated) | Unclear (not stated) | DB (placebo used, teicoplanin colour masked, only pharmacist aware of treatment assignment) | Yes, but analysis based on episodes | Wound infection (biopsy and quantitative tissue or skin cultures); pneumonia (respiratory infection manifested by sepsis and increase of purulent tracheobronchial secretions or worsening pulmonary gas exchange); P aeruginosa and S aureus infections; bacteraemia; candidaemia | Related and unrelated; infections caused by teicoplanin-resistant staphylococci and MRSA. Wound and blood surveillance |
| Ugburo 200464 | Adequate (table of random numbers) | Unclear (not stated) | Open | Yes | Wound infection (clinical infection using previously proposed criteria 68, with histological and microbiological confirmation); P aeruginosa and S aureus infections | NA. Wound surveillance |
*DB=double blind; patient and carer were blinded to treatment; NA=not assessed.
†Resistance trait and types of infections reported and relation to study drugs (related: assessment of resistance to one or more of the study drugs; unrelated: assessment of a resistance trait unrelated to the study antibiotics) and surveillance cultures reported.