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. 2019 Mar 26;2019(3):CD009261. doi: 10.1002/14651858.CD009261.pub4

Crist 2014.

Methods Study design: randomised controlled trial
 Study grouping: parallel
Ethics and informed consent: ethics approved and consent obtained
Follow‐up period: 12 months
Sample size calculation: not stated
ITT analysis: available‐case analysis
Funding: non‐industry
Pre‐registration: yes
Participants Location: USA
 Intervention group: n = 55control group: n = 60
Mean age: intervention group = 47.2 years (SD 19.6)control group = 48.3 years (SD 20.1). Data extracted from results section of ClinicalTrials.gov (NCT00635479).
 Inclusion criteria: patients that had undergone an open surgical exposure for hip, pelvis, or acetabular fracture
 Exclusion criteria: none stated
Interventions Aim/s: to determine the effectiveness of using NPWT over primarily closed surgical incisions used for open reduction and internal fixation of hip, pelvis, and acetabular fracture surgery
Group 1 (NPWT) intervention: quote "negative pressure dressing applied over the primarily closed incision sterilely in the operating room. NPWT was left on for 2 days or longer if drainage continued"
Group 2 (control) intervention: quote "standard gauze dressing"; description not provided
 Study date/s: not provided
Outcomes
  • infection

  • LOS

  • total serious adverse events


Validity of measure/s: not provided
Time points: followed for 12 months
Notes Conference abstract. Additional information provided by the investigator and from a search of ClinicalTrials.gov (NCT00635479).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Evidence: quote "computer randomization"
Comment: correspondence with author
Allocation concealment (selection bias) Low risk Evidence: quote "opaquesealed envelope opened in the OR"
Comment: correspondence with author
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 Low risk Evidence: quote "yes"
Comment: correspondence with author
Incomplete outcome data (attrition bias) 
 All outcomes High risk Evidence: quote "55 patients randomised to the NPWT group and 60 patients randomised to the standard dressing group. The NPWT group included 49 patients and the gauze group included 42 patients that completed the 12 month follow‐up"
Comment: 10.9% participants in NPWT group and 30.0% of those in control group were lost to follow‐up.
Selective reporting (reporting bias) Low risk Comment: protocol registered on ClinicalTrials.gov with identifier (NCT00635479). Expected outcomes were reported in the abstract, but other outcomes specified in the protocol were not reported (such as total serious adverse events). These may be included when the full trial is published.
Other bias Unclear risk Comment: no other biases detected