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Full Title: Wound-Healing Technologies: Low-Level Laser and Vacuum-Assisted Closure
View or download Summary/Report
Objectives: To systematically review evidence on low-level laser therapy or vacuum-assisted closure on wound-healing outcomes. Chronic wounds are a major source of morbidity, disability, and mortality, having a significant impact on public health and health care resource expenditure.
Data Sources: MEDLINE® (through June 8, 2004), EMBASE (through June 14, 2004), and the Cochrane Controlled Trials Register (through 2003) were searched. Primary published evidence was supplemented with recent meeting abstracts and clinical trial protocols.
Review Methods: Included studies were full-text journal articles reporting on randomized, controlled trials (RCTs) of low-level laser therapy of vacuum-assisted closure of wounds compared with alternative interventions or placebos, or to determine any incremental benefit. Low-level laser trials had to include only chronic wounds, while vacuum-assisted closure trials could include various wound types. Primary outcomes of interest were incidence of complete wound closure, time to complete closure, and adverse events. Outcomes of interest were summarized in tables and synthesized across studies.
Results: For low-level laser therapy, 11 studies (n=413) met study selection criteria. For vacuum-assisted closure, 6 studies (n=135) met study selection criteria.
Conclusions: Evidence was limited by poor trial quality. Concerns centered on: randomization adequacy; group comparability at baseline and followup; use of complete healing as the primary endpoint; adjustment for confounders; and intention-to-treat analysis. Sample sizes were generally small, making it difficult to find statistically significant differences between groups.
The best available trial did not show a higher probability of complete healing at 6 weeks with the addition of low-level laser compared to sham laser treatment added to standard care. Study weaknesses were unlikely to have concealed existing effects. Future studies may determine whether different dosing parameters or other laser types may lead to different results.
Vacuum-assisted closure trials did not find a significant advantage for the intervention on the primary endpoint, complete healing, and did not consistently find significant differences on secondary endpoints and may have been insufficiently powered to detect differences. Ongoing RCT protocols may provide better evidence on outcomes of interest.
Given the sparse evidence for these two interventions, at the present time, it is not possible to find variables in these trials that may be associated with better results.
Wound-Healing Technologies: Low-Level Laser and Vacuum-Assisted Closure
Evidence-based Practice Center: Blue Cross and Blue Shield Evidence-based Practice Center
Topic Nominator: American Association of Health Plans
Current as of December 2004