ABSTRACT
OBJECTIVE: This non-comparative phase II study aimed to evaluate the safety and performance of a non-adhesive gelling foam dressing (GFD-N) in leg ulcer management. METHOD: Forty-six subjects with moderately to heavily exuding leg ulcers were treated with a regimen including GFD-N. Dressings were changed at least every seven days for four weeks or until healing. RESULTS: Mean GFD-N wear time was 3.2 days per subject. Mean wound area decreased from 10.1 cm2 at baseline to 5.1 cm2 at four weeks (p<0.001) and healed in five subjects (11%). The surrounding skin improved or remained stable in all but one subject. When compared with pre-study dressings, ulcer pain decreased for GFD-N, both with the dressing in place (p<0.001) and on dressing removal (p<0.001). Of final investigator ratings for 45 subjects, most were 'excellent' for ease of application (89%), ease of removal (96%), conformability (67%) and overall performance (58%). Five subjects experienced adverse events; none were serious or dressing-related. CONCLUSION: This small study demonstrates that GFD-N was safe, effective and convenient for wound healing, exudate management, pain/comfort and ease of use.
Subject(s)
Bandages , Leg Ulcer/therapy , Adult , Aged , Exudates and Transudates , Female , Gels , Humans , Leg Ulcer/physiopathology , Male , Prospective Studies , Wound HealingABSTRACT
In a multicenter trial, the effect of a commercially available combination of autologous keratinocytes (3-6 x 10(6)/mL) with fibrin sealant (Tissucol Duo S Immuno, Baxter Hyland Immuno) on the healing of recalcitrant venous leg ulcers (duration >3 months) was compared with standard care. The primary endpoint was time to healing, and the secondary endpoint was number of healed ulcers in both groups. Both groups received compression therapy with short-stretch bandages. Forty-four (38.3%) of the 116 patients who had BioSeed-S treatment achieved complete healing of the target ulcer compared with 24 (22.4%) of 109 patients who received standard treatment. The advantage for treatment with BioSeed-S over standard treatment was statistically significant (chi-square test: p=0.0106). Time to complete healing of ulcers: the log-rank test for equality over strata revealed a superiority of treatment with BioSeed-S+compression (median: 176 days) over compression+standard care (median >201 days) (p<0.0001). This study, to date the largest multicenter study with autologous keratinocytes, provides evidence for its efficacy in the treatment of patients with therapy-resistant chronic venous leg ulcers.
Subject(s)
Fibrin Tissue Adhesive/therapeutic use , Keratinocytes/transplantation , Leg Ulcer/therapy , Varicose Ulcer/therapy , Adult , Aged , Aged, 80 and over , Bandages , Chi-Square Distribution , Female , Humans , Male , Middle Aged , Statistics, Nonparametric , Transplantation, Autologous , Treatment OutcomeABSTRACT
The notion that chronic wounds are merely a variant of acute wounds is obsolete. The pathophysiology of chronic wounds differs in essence from that of acute wounds. The former is a specific pathological entity that requires both a systematic disease-specific diagnostic work-up and treatment. For the diagnosis and treatment of chronic wounds, the Wound Bed Preparation Advisory Board has proposed a new conceptthat goes bythe acronym of TIME, the letters of which refer to the structures to be diagnosed and treated: T = tissue, I = inflammation or infection, M = moisture (wound exudate), E = edge (of the wound). The present article discusses the principles and scientific background to this TIME concept.
Subject(s)
Critical Pathways , Wounds and Injuries/therapy , Anti-Infective Agents, Local/administration & dosage , Bandages , Chronic Disease , Combined Modality Therapy , Debridement , Exudates and Transudates/metabolism , Humans , Therapeutic Irrigation , Wound Healing/physiology , Wound Infection/etiology , Wound Infection/physiopathology , Wound Infection/therapy , Wounds and Injuries/etiology , Wounds and Injuries/physiopathologyABSTRACT
OBJECTIVE: To compare the performance of two compression systems, (multilayer elastic [Profore], Smith and Nephew) and (short stretch [Comprilan], Beiersdorf), in the treatment of venous leg ulcers in a randomised controlled trial. METHOD: Eighty-nine patients with venous leg ulcers were randomised to receive treatment with Profore (44 patients) or short-stretch (45 patients) compression bandages. Allevyn (Smith and Nephew) was used as the wound contact layer under both systems. RESULTS: Patients treated with Profore healed significantly faster than those treated with short stretch (p = 0.03) and were 2.9 times more likely to heal at any given time during the study period. Younger wounds healed significantly faster than older wounds (p = 0.01). CONCLUSION: Patients treated with Profore healed faster than those treated with short-stretch bandages. In addition, treatment costs are lower with Profore. In this trial the average cost per patient was [symbol: see text] 1345 (short stretch) and [symbol: see text] 587 (Profore).
