Lozano‐Balderas 2017.
| Methods |
Study design: randomised controlled trial
Ethics and informed consent: ethics approved Sample size calculation: no ITT analysis: yes number randomised: 81 number analysed: 81 Follow‐up period: healed (when in hospital) or in a 30‐day period after surgery (if discharged) Funding: non‐industry Pre‐registration: yes |
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| Participants |
Location: Mexico
Intervention group: n = 25control group: n = 27 (3 arms: delayed primary closure group: n = 29) Median age (IQR): intervention group = 32 (22 to 46);control group = 30 (20 to 43) Inclusion criteria: minimum age of 18; a laparotomised wound with class III or IV (contaminated/dirty‐infected) surgical wounds Exclusion criteria: not specified |
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| Interventions |
Aim/s: to compare infection rates between primary, delayed primary, and vacuum‐assisted closures in contaminated/dirty‐infected surgical wounds Group 1 (NPWT) intervention: the VAC was used with routine changes of dressings every 48 hours until healthy granulation tissue was found and a surgeon decided to close it. Group 2 (control) intervention: subcutaneous tissue was approximated with polyglycolic acid, and polypropylene was used for the skin. Study date/s: January to July 2014 |
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| Outcomes |
Validity of measure/s: according to the CDC Surgical Wound Classification Time points: daily when in hospital or in a 30‐day period after surgery |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "patients were allocated to each group with the software Research Randomizer® (Urbaniak, G. C., & Plous, S., Version 4.0)" |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| 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 | High risk | Outcome assessors were aware of group allocation. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 81 participants were enrolled and analysed. |
| Selective reporting (reporting bias) | Low risk | Expected outcomes reported. Protocol retrospectively registered on ClinicalTrials.gov (NCT02649543). |
| Other bias | Low risk | No other biases detected. |