Arti 2016.
Methods | 2‐arm RCT Conducted in Iran Follow‐up: 1 month |
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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 |
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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. |
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Outcomes |
Primary review outcomes: wound infection (defined as purulent discharge from the wound site or positive culture of the wound) Secondary review outcomes: none |
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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 |