Øyvind Heiberg Sundby1,2,3, Ingebjørg Irgens4,5, Lars Øivind Høiseth6,7, Iacob Mathiesen8, Eivind Lundgaard5, Hanne Haugland9, Harald Weedon-Fekjær10, Jon O Sundhagen11, Gunnar Sandbæk4,12, Jonny Hisdal6. 1. Section of Vascular Investigations, Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway. oyvindheibergsundby@gmail.com. 2. Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway. oyvindheibergsundby@gmail.com. 3. Otivio AS, Gaustadalléen 21, 0349, Oslo, Norway. oyvindheibergsundby@gmail.com. 4. Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway. 5. Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway. 6. Section of Vascular Investigations, Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway. 7. Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway. 8. Otivio AS, Gaustadalléen 21, 0349, Oslo, Norway. 9. Department of Spinal Cord Injury, Sunnaas Rehabilitation Hospital, Oslo, Norway. 10. Oslo Center for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway. 11. Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway. 12. Department of Radiology, Oslo University Hospital, Oslo, Norway.
Abstract
STUDY DESIGN: Randomized, assessor-blinded crossover pilot study. OBJECTIVES: To explore the use of an intermittent negative pressure (INP) device for home use in addition to standard wound care (SWC) for patients with spinal cord injury (SCI) and chronic leg and foot ulcers before conducting a superiority trial. SETTING:Patient homes and outpatient clinic. METHODS: A 16-week crossover trial on 9 SCI patients (median age: 57 years, interquartile range [IQR] 52-66), with leg ulcers for 52 of weeks (IQR: 12-82) duration. At baseline, patients were allocated to treatment with INP + SWC or SWC alone. After 8 weeks, the ulcers were evaluated. To assess protocol adherence, the patients were then crossed over to the other group and were evaluated again after another 8 weeks. Lower limb INP treatment consisted of an airtight pressure chamber connected to an INP generator (alternating 10 s -40mmHg/7 s atmospheric pressure) used 2 h/day at home. Ulcer healing was assessed using a photographic wound assessment tool (PWAT) and by measuring changes in wound surface area (WSA). RESULTS: Seven of nine recruited patients adhered to a median of 90% (IQR: 80-96) of the prescribed 8-week INP-protocol, and completed the study without side effects. PWAT improvement was observed in 4/4 patients for INP + SWC vs. 2/5 patients for SWC alone (P = 0.13). WSA improved in 3/4 patients allocated to INP + SWC vs. 3/5 patients in SWC alone (P = 0.72). CONCLUSIONS: INP can be used as a home-based treatment for patients with SCI, and its efficacy should be tested in an adequately sized, preferably multicenter randomized trial.
RCT Entities:
STUDY DESIGN: Randomized, assessor-blinded crossover pilot study. OBJECTIVES: To explore the use of an intermittent negative pressure (INP) device for home use in addition to standard wound care (SWC) for patients with spinal cord injury (SCI) and chronic leg and foot ulcers before conducting a superiority trial. SETTING:Patient homes and outpatient clinic. METHODS: A 16-week crossover trial on 9 SCI patients (median age: 57 years, interquartile range [IQR] 52-66), with leg ulcers for 52 of weeks (IQR: 12-82) duration. At baseline, patients were allocated to treatment with INP + SWC or SWC alone. After 8 weeks, the ulcers were evaluated. To assess protocol adherence, the patients were then crossed over to the other group and were evaluated again after another 8 weeks. Lower limb INP treatment consisted of an airtight pressure chamber connected to an INP generator (alternating 10 s -40mmHg/7 s atmospheric pressure) used 2 h/day at home. Ulcer healing was assessed using a photographic wound assessment tool (PWAT) and by measuring changes in wound surface area (WSA). RESULTS: Seven of nine recruited patients adhered to a median of 90% (IQR: 80-96) of the prescribed 8-week INP-protocol, and completed the study without side effects. PWAT improvement was observed in 4/4 patients for INP + SWC vs. 2/5 patients for SWC alone (P = 0.13). WSA improved in 3/4 patients allocated to INP + SWC vs. 3/5 patients in SWC alone (P = 0.72). CONCLUSIONS: INP can be used as a home-based treatment for patients with SCI, and its efficacy should be tested in an adequately sized, preferably multicenter randomized trial.
Authors: Victor Aboyans; Michael H Criqui; Pierre Abraham; Matthew A Allison; Mark A Creager; Curt Diehm; F Gerry R Fowkes; William R Hiatt; Björn Jönsson; Philippe Lacroix; Benôit Marin; Mary M McDermott; Lars Norgren; Reena L Pande; Pierre-Marie Preux; H E Jelle Stoffers; Diane Treat-Jacobson Journal: Circulation Date: 2012-11-16 Impact factor: 29.690