Topical negative pressure (TNP) therapy is widely used in the treatment of acute wounds in vascular patients on the basis of proposed multifactorial benefits. However, numerous recent systematic reviews have concluded that there is inadequate evidence to support its benefits at a scientific level. This study evaluated the changes in wound volume, surface area, depth, collagen deposition, and tissue oxygenation when using TNP therapy compared with traditional dressings in patients with acute high-risk foot wounds.Methods:
This study was performed with hospitalized vascular patients. Forty-eight patients were selected with an acute lower extremity wound after surgical débridement or minor amputation that had an adequate blood supply without requiring further surgical revascularization and were deemed suitable for TNP therapy. The 22 patients who completed the study were randomly allocated to a treatment group receiving TNP or to a control group receiving regular topical dressings. Wound volume and wound oxygenation were analyzed using a modern stereophotographic wound measurement system and a hyperspectral transcutaneous oxygenation measurement system, respectively. Laboratory analysis was conducted on wound biopsy samples to determine hydroxyproline levels, a surrogate marker to collagen.Results:
Differences in clinical or demographic characteristics or in the location of the foot wounds were not significant between the two groups. All patients, with the exception of two, had diabetes. The two patients who did not have diabetes had end-stage renal failure. There was no significance in the primary outcome of wound volume reduction between TNP and control patients on day 14 (44.2% and 20.9%, respectively; P = .15). Analyses of secondary outcomes showed a significant result of better healing rates in the TNP group by demonstrating a reduction in maximum wound depth at day 14 (36.0% TNP vs 17.6% control; P = .03). No significant findings were found for the other outcomes of changes in hydroxyproline levels (58.0% TNP vs 94.5% control; P = .32) or tissue perfusion by tissue oxyhemoglobin saturation (19.4% TNP vs 12.0% control; P = .07) at day 14. At 1 year of follow-up, there were no significant outcomes in the analysis of wound failure, major amputation, and overall survival rates between the two groups.Conclusions:
In this pilot study, applying TNP to acute high-risk foot wounds in patients with diabetes or end-stage renal failure improved the wound healing rate in reference to wound depth. This suggests that TNP may play a role in enhancing wound healing. This study sets the foundation for larger studies to evaluate the superiority of TNP over traditional dressings in high-risk foot wounds.