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. 2011 Jun 3;108(22):381–389. doi: 10.3238/arztebl.2011.0381

eTable 2. Trial characteristics: inclusion and exclusion criteria.

RCT Inclusion criteria Exclusion criteria
Commercially available systems
Blume 2008 (8) At least 18 years old, diabetes, foot ulcer at least 2 cm2, Wagner grade 2 or 3 Active Charcot foot; ulcers not caused by electrical, chemical or radiation burns; collagen vascular diseases; neoplastic ulceration; untreated osteomyelitis; cellulitis; uncontrolled hyperglycemia with HbA1c above 12%; inadequate blood circulation in the legs; hyperbaric oxygen therapy; corticosteroid treatment, immunosuppressant treatment, or chemotherapy; growth factors; skin replacement less than 30 days after the beginning of the trial; enzymatic debridement; pregnant women; breastfeeding mothers
Chio 2010 (9) Adults, status following removal of a free radial forearm flap Not available
Keskin 2008 (10) Age ≥ 18 years, traumatic leg wounds Hemodynamic instability; lack of orientation or inability to cooperate
Stannard 2009 (11) Age ≥ 18 years, severe open fractures requiring repeat debridement Open fractures successfully closed after first operation; infected open fractures; incisions not treatable with NPWT; prisoners; pregnant women
Systems not commercially available
Bee 2008 (12) Age ≥ 18 years, exploratory laparotomy following trauma or emergency surgery, indication for abdominal closure Prisoners; pregnant women; life expectancy 7 days or less
Mody 2008 (13) Acute or chronic wounds in the extremities or sacral region or abdominal wounds that could not be closed by initial surgery Wounds in a part of the body where it would be hard to apply negative pressure; ischemic wounds; wounds with exposed intestine or blood vessels; wounds with necrotic tissue that could not be debrided; wounds with fistulas, osteomyelitis, neoplasia; contraindications according to manufacturer; anticoagulant treatment
Perez 2010 (14) Individual acute or chronic wounds Bone injuries; vascular ulcers
Saaiq 2010 (15) Age ≥ 13 years, acute traumatic wounds up to 6 weeks old, wound surface area at least 9 cm2 Diabetes mellitus, neoplasia, or increased tendency to bleed; need for flap surgery
Sepúlveda 2009 (16) Age ≥ 18 years, type 2 diabetes mellitus, wounds following transmetatarsal amputation of 2 or more adjacent toes or the big toe; caused by infection or reduced blood circulation; adequate circulation in the affected leg; metatarsal pulse volume at least 5 mm, systolic blood pressure at least 15 mmHg, ankle–brachial index at least 0.5, foot pulse palpable or status following successful revascularization Active Charcot foot; uncontrolled hyperglycemia with HbA1c above 12%; corticosteroid treatment, immunosuppressant treatment, or chemotherapy; severe nutritional disturbances with albumin levels below 2.1 mg/dL; growth factor treatment or hyperbaric oxygen therapy