Sebold 1993.
Methods | Study design: randomised controlled trial Object of randomisation: operations | |
Participants | US Surgeons performing major joint arthroplasty Number studied: 284 gloves inner or outer gloves (71 operations) Intervention 1: n = 100; Intervention 2: n = 96; control group: n = 88 | |
Interventions | 1) Double gloving with thicker glove (orthopaedic outer gloves and latex inner gloves)
Control group was double latex gloves 2) Triple gloving with latex outer gloves, cloth middle gloves and latex inner gloves Control group 1 was double latex gloved; control group 2 was double gloving with thicker glove |
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Outcomes | Outcome: number of inner glove perforations per total number of inner gloves Perforation detection: the gloves were filled with water and perforations were noted as a jet of water Secondary outcome: self detection of glove perforations | |
Notes | Double versus double: Sebold 1993; triple versus double Sebold 1993 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Low risk | Cards indicating glove type in envelopes, sealed and shuffled, numbered from 1 to 75 |
Allocation concealment | Low risk | Envelopes sealed until beginning of OP |
Blinding of study subjects | Low risk | Not possible; knowledge about the gloving method judged as having a low risk of changing the outcome |
Blinding of outcome assessor | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) | Low risk | 3 out of 25 cases in control excluded; 1 out of 25 in cloth glove group excluded |
Selective outcome reporting (reporting bias) | Low risk | Perforations reported for inner, outer, changed gloves |
Outcome measure (combined air and water test used?) | High risk | Water test only |