Stannard 2012.
| Methods |
Study design: multicentre randomised controlled trial (4 level 1 trauma centres)
Ethics and informed consent: ethics approved and consent obtained Sample size calculation: no Follow‐up period: not reported ITT analysis: wounds, not people were assessed Funding: "funds from corporate/industry were received from Kinetic Concepts, Inc to support this work" |
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| Participants |
Location: Columbus, Ohio, USA Intervention group: n = 130 participants; 141 fracturescontrol group: n = 119 participants; 122 fractures Mean age: not stated Inclusion criteria: people > 18 years of age who had sustained a high‐energy tibial plateau, pilon, or calcaneus fracture and were able to comply with research protocol and willing to give informed consent Exclusion criteria: non‐operative calcaneus, tibia plateau, or pilon fractures; patients with open calcaneus fractures; tibial plateau or calcaneus fractures receiving definitive surgery more than 16 days after injury; pilon fractures receiving definitive surgery more than 21 days after injury; prisoners; pregnant women; patients with one of these fractures as a result of a low‐energy mechanism of injury; patients or family members unable or unwilling to sign study informed consent; and patients unable to comply with the protocol |
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| Interventions |
Aim/s: "to investigate the use of NPWT to prevent wound dehiscence and infection after high‐risk lower extremity trauma"
Intervention/s in both groups: dressings or NPWT were applied in the operating room and then changed on postoperative day 2 and every 1 to 2 days thereafter. Group 1 (NPWT) intervention: NPWT over the surgical incision after open reduction and internal fixation of the fracture Group 2 (control) intervention: standard postoperative dressing (dressing not described) Study date/s: not stated |
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| Outcomes |
Validity of measure/s: "all infections were confirmed with cultures" Time points: not stated ‐ unclear for how long participants were followed up |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Evidence: quote: "patients were enrolled and then randomised to receive either standard postoperative dressings (control) or NPWT (study)" Comment: additional author information: "the randomization was done via a computer generated randomization program" |
| Allocation concealment (selection bias) | Unclear risk | Comment: method not clarified. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk |
Evidence for participants: not possible Comment: unlikely to affect outcomes Evidence for personnel: not possible Comment: unlikely to affect outcomes |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk |
Evidence: quote: "a patient was diagnosed as having an infection when a combination of clinical signs and symptoms (purulent drainage, erythema, fever, chills, etc) and laboratory data documented the infection. All infections were confirmed with cultures. Wound dehiscence was defined as any separation of the surgical incision that required either local wound care or surgical treatment" Comment: not clear whether those assessing outcomes were aware of group assignment |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: a total of 249 participants were recruited. The same number of participants were reported for both acute and long‐term follow‐up (follow‐up period not defined). Given that 4 hospitals were involved in the study, it seems unusual that complete follow‐up would have occurred, suggesting that an available‐case analysis may have been performed. |
| Selective reporting (reporting bias) | Low risk | Comment: registered in CTR (NCT00582998) 9 months after final data collection date, so it is unclear whether reported outcomes match the original protocol. However, infection and dehiscence were the expected outcomes. |
| Other bias | High risk |
Comment:
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