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. 2018 Jul 3;2018(7):CD012522. doi: 10.1002/14651858.CD012522.pub2

Arti 2016.

Methods 2‐arm RCT
Conducted in Iran
Follow‐up: 1 month
Participants 90 participants with open fractures
Inclusion criteria: aged 15‐55 years; open fracture wound type IIIB based on G/A classification, and accessible clean wound after debridement
Exclusion criteria: type I, II or IIIA and IIIC based on G/A classification; need of vascular repair or reconstruction; presence of multiple fractures in extremities; malnutrition; systemic disease; dermatological disease like psoriasis; taking immunosuppressive drugs; existence of old fracture or implant in the fractured extremity and previous osteomyelitis
Interventions Group A (n = 45): conventional wound dressing; changed twice a day. No further details
Group B (n = 45): NPWT VAC. The dressings were changed usually every 48 hand NPWT continued for 10‐14 days. Pressure was maintained at 125 mm Hg continuously or intermittently 5 min on 2 min off. Therapy was stopped when an adequate granulation base was achieved allowing for change to conventional dressing, split‐thickness skin graft, or flap closure.
Co‐intervention: open fracture in both wounds underwent debridement before treatment.
Outcomes Primary review outcomes: wound infection (defined as purulent discharge from the wound site or positive culture of the wound)
Secondary review outcomes: none
Notes Funding source not noted but study authors declare no conflicts of interest, the vice‐chancellor for research of Ahwaz
 Jundishapur University of Medical Sciences is thanked for support. Research noted as being “derived from a speciality thesis” of one of the study authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “It is a prospective randomised clinical trial study by simple convenience sampling conducted”
“Then patients were matched for age, sex and type of open fracture and were assigned to either one of two groups based on random table numbers”
Comment: a random number table used. Possible robust randomisation but process not clear from paper ‐ classed as unclear
Allocation concealment (selection bias) Unclear risk Quote: See above
Comment: methods of allocation concealment unclear
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: no quote
Comment: no mention of blinding but would not be possible to blind health professionals to the different treatments so without further detail considered high risk
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: no quote
Comment: no mention of blinding in the paper
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: no quote
Comment: no evidence of loss to follow‐up or missing data
Selective reporting (reporting bias) High risk Quote: “Wound healing duration, presence of infection”
Comment: wound surface reduction was reported rather than wound healing duration
Other bias Unclear risk Quote: no quote
Comment: none noted but reporting insufficient to be certain