Wounds : a compendium of clinical research and practice最新文献

Background: Fat pad atrophy or migration leads to high pressure, a key factor in chronic plantar ulcer development. Current standard of care (SOC) only offers temporary pressure relief through off-loading, without addressing underlying fat pad defects.

Objective: To assess the intraoperative use of human cryopreserved adipose tissue allograft (hCAT) alongside SOC for patients with chronic recalcitrant plantar ulcers persisting longer than 12 months.

Materials and methods: Eight patients with significant comorbidities, including diabetes mellitus, peripheral vascular disease, and chronic kidney disease, were included in this retrospective case series. The average ulcer size was 3.69 cm² (range, 0.14 cm²-20 cm²) with an average duration of 39.6 months (range, 21 months-59 months). Each patient underwent surgical debridement followed by hCAT implantation in the periwound area, followed by SOC. Outcomes included ulcer closure rate, time to closure, ulcer-free duration, and hCAT-related adverse events.

Results: Seven patients (87.5%) achieved complete closure within 2.8 months on average (range, 0.8 months-7.2 months) with a post-closure ulcer-free duration averaging 5.6 months (range, 3.5 months-7.7 months) at the time of data analysis. No hCAT-related adverse events were observed. Patients are still being followed for longer-term outcomes.

Conclusion: These findings support hCAT as an effective adjunct to SOC in the management of chronic recalcitrant plantar ulcers.

Background: Delayed wound healing (DWH) leads to various health problems and increases the cost of health care for patients.

Objective: To identify the determinants associated with DWH in postoperative patients.

Materials and methods: This prospective study included 225 postoperative patients admitted to 3 tertiary care hospitals in south India. Data were collected by interviewing each patient. DWH was defined as absence of wound retraction 10 days postoperative.

Results: Nonhealing of the surgical wound was noted in 96 patients (42.7%). In the multivariable analysis, the presence of comorbidities like obesity and hypertension, an American Society of Anesthesiologists score of II or III, not using ceftriaxone with sulbactam prophylactically before surgery, an increased fasting blood sugar status in the postoperative period, and resistance to fluoroquinolones and aminoglycosides in the culture and sensitivity reports were associated with DWH in the patients studied.

Conclusion: Detailed preoperative evaluation of patients, controlling comorbidities, using appropriate antibiotics, and postoperative control of blood sugars in patients with diabetes, as well as culture and sensitivity testing, are needed to minimize the occurrence of DWH.

Background: Chronic wounds present significant clinical challenges and often require advanced modalities such as cellular and/or tissue-based products (CTPs), also referred to as cellular, acellular, and matrix-like products. Bioactive skin allograft (BSA) is a type of CTP composed of living fibroblasts, keratinocytes, cytokines, and collagen that is widely used for nonhealing wounds. Before applying a BSA, standard of care involves lowering the bioburden through wound bed preparation; however, classic methods to assess bioburden can be unreliable. Bacterial fluorescence imaging (FL-imaging) is a recent technology that allows for the detection of clinically significant bioburden using a noninvasive, point-of-care device. Few studies have applied FL-imaging directly to BSA management.

Objective: To evaluate the use of FL-imaging to direct and manage the use of BSAs before, during, and after their application.

Materials and methods: BSAs were applied after ensuring adequate tissue perfusion, 30 days of local wound care, and medical optimization. Debridement was performed and adequacy verified using FL-imaging before BSA placement. FL-imaging was used to monitor graft sites at day 3, 7, and 14 after initial application.

Results: Although FL-imaging confirmed initial debridement success, subsequent scans revealed bioburden recurrence that compromised BSA viability in several cases. These findings informed the development of a preliminary protocol using FL-imaging to confirm adequate debridement and guide postoperative graft monitoring and salvage.

Conclusion: The systematic adoption of FL-imaging could provide a consistent method for wound bed preparation and graft monitoring in the future, while encouraging clinicians to use BSAs with a cost-efficient, consistent, and evidence-based approach.

Background: This retrospective analysis is a derivative cohort study based on a prior retrospective investigation by this author group.

Objective: To assess the effect of the number of cellular and/or tissue-based product (CTP) applications on healing outcomes and wound area reduction (WAR) rates in patients with chronic wounds of multiple etiologies.

Methods: Data from a multicenter private wound care practice electronic health record database were analyzed for Medicare patients receiving CTPs from January 2018 through December 2023. Wound treatments were administered in nursing homes (4.77%), private clinics (80.11%), and home settings (15.65%), excluding hospital outpatient department settings. This retrospective analysis evaluated WAR and closure rates following each CTP application.

Results: A total of 446 wounds were included in the analysis, comprising 123 diabetic foot ulcers (DFUs), 134 venous leg ulcers (VLUs), 62 surgical wounds, 51 trauma wounds, and 76 other chronic wounds. Significant reductions in average wound areas (cm²) were observed after completing the CTP application series (ie, ≤10 CTPs within 16 weeks) for all chronic wounds (P < .001). Further, there were more total healed wounds noted for the chronic surgical and trauma wounds compared with DFUs and VLUs.

Conclusion: This retrospective real-world analysis of Medicare patients undergoing CTP therapy in conjunction with standard of care for chronic trauma and surgical wounds demonstrates substantial reductions in wound area following completion of a CTP application series. Findings from this study may guide governing bodies regarding CTP best practice recommendations in the treatment of chronic wounds of various etiologies.

Background: Pressure injuries are common, difficult to manage, and carry a high economic burden. They are challenging to physicians and a burden to society.

Case report: An 89-year-old male, who had previously undergone internal fixation with screws and rods for a right intertrochanteric fracture, developed a deep circular open ulcer measuring 11 cm × 7.5 cm on his right hip after being bedridden for over 20 consecutive days because of symptoms of coughing and fatigue. Upon examination, the ulcer exhibited extensive necrotic tissue, purulent discharge, and a foul odor at its base. Following multiple debridement procedures, a multilayer tension reduction and repair surgery using the Kirschner wire technique in conjunction with elastic tape was performed on the 31st day of hospitalization. The wound achieved complete healing, and the patient was discharged on the 102nd day of admission. During the 6-month postoperative follow-up period, the appearance and sensory function of the wound skin were observed to have recovered satisfactorily.

Conclusion: In this case, the use of Kirschner wires combined with elastic tape for multilayer tension reduction resulted in the repair of a large stage 4 pressure injury at the greater trochanter. The mechanism of action is discussed and analyzed to provide clinical evidence for such treatment.

Background: Diabetic foot ulcers (DFUs) are a major clinical challenge, particularly among patients with refractory ulcers, that often lead to severe complications such as infection, amputation, and high mortality. Innovations supported by strong clinical evidence have the potential to improve healing outcomes, enhance quality of life, and reduce the economic burden on individuals and health care systems.

Objective: To describe the design of the concurrent optical and magnetic stimulation (COMS) therapy Investigational Device Exemption (IDE) study for refractory DFUs (MAVERICKS) trial.

Materials and methods: The MAVERICKS trial is a pivotal, multicenter, randomized, sham-controlled, double-blind study designed to evaluate the efficacy and safety of COMS therapy as an adjunct to standard of care for hard-to-heal DFUs. What differentiates MAVERICKS is its extended screening phase, ensuring the inclusion of truly refractory ulcers, thus addressing a critical gap in previous DFU research. With an expected enrollment of 224 patients across diverse clinical settings, the trial incorporates robust methodologies to eliminate bias, and comprehensive inclusion and exclusion criteria to ensure data integrity. The study's primary outcome measure, time to complete wound closure, as well as secondary end points including wound area reduction and time to amputation, will provide credible insights into the therapeutic potential of COMS.

Conclusion: The MAVERICKS trial is particularly significant for investigating a novel, accessible, and cost-effective approach to advance DFU treatment. This trial sets a high standard in DFU research and seeks to provide reliable evidence to improve patient outcomes and guide future clinical practice. Upon trial completion, the authors look forward to sharing the findings and outcome analysis with wound care stakeholders. The study is registered under ClinicalTrials.gov identifier NCT05758545, effective March 7, 2023.

Background: Initially limited to inpatient use, negative pressure wound therapy (NPWT) is now frequently used in community settings. However, complexities in wound management step-down strategies in the United Kingdom, including regional variations in referral processes, lack of consensus on funding criteria, and limited availability of NPWT units, have led to extended hospital length of stay (LOS) for patients ready for discharge but still needing NPWT. Single-use NPWT (sNPWT) can serve as a bridge between hospital and community NPWT.

Objective: To assess the feasibility, effectiveness, and potential cost savings of the implementation of a discharge pathway utilizing sNPWT.

Methods: This case series included 5 patients with open lower limb wounds treated at a National Health Service facility using an sNPWT discharge pathway. Wounds were assessed before and after sNPWT use. Differences in average inpatient LOS and costs were calculated and compared with those for patients who remained hospitalized until community NPWT was available.

Results: The sNPWT discharge pathway was well tolerated by patients and resulted in good clinical outcomes. Patients discharged on sNPWT had an average reduction in LOS of 20.2 days, resulting in a projected £12 350 savings in hospital costs per patient.

Conclusion: Preliminary findings indicate use of an sNPWT discharge pathway is feasible and may result in reduced LOS and associated costs while improving patient care. Additional studies are needed to understand the effect on wound management, patient outcomes, and overall care costs.

Background: Current management of pediatric cutaneous abscesses involves either spontaneous healing by secondary intention or suturing through tertiary intention, which are often lengthy processes that cause discomfort and distress among children. As it is noninvasive and simple, a novel zipper device is widely used for the primary wound closure of surgical incisions.

Objective: To describe the effectiveness of novel zipper device use for pediatric cutaneous abscess wound closure in an outpatient context.

Materials and methods: A total of 26 pediatric outpatients with simple cutaneous abscesses were included. After incision and drainage (I and D), the novel zipper device was applied once pus decreased significantly and fresh granulation tissue emerged. Wound healing time and pain score were tracked over the intervention period. Linear regression and restricted cubic spline models were also used to analyze the relationship between the intervention interval of time from I and D to zipper application and wound healing time.

Results: The average (SD) wound healing time was 12.73 (3.16) days. Pain scores decreased significantly from a median of 2 during zipper use to 0 at removal. Linear regression analysis revealed 2 healing time predictors: infection size (B = 0.260, SE = 0.090, β = 0.260, t = 2.924, P = .008) and intervention interval of zipper use (B = 0.850, SE = 0.090, β = 0.810, t = 9.187, P = .001). A linear dose-response relationship was observed between intervention interval and healing time (Ptotal < .001, Pnonlinear = .406).

Conclusion: This case series identifies the fifth day post-I and D as a potential threshold, and suggests that the optimal period of zipper device use is 3 days to 5 days following I and D of skin abscess to enhance early wound healing, beyond which extended intervention intervals prolong wound healing time.

Background: To estimate the prevalence of biofilms in chronic wounds.

Methods: The authors performed a systematic review of prevalence studies and meta-analysis, structured according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Articles were searched in Scopus (Elsevier), Web of Science (Clarivate), MEDLINE/PubMed (National Institutes of Health), and Embase (Elsevier) databases. Data collected included the author and year of publication, total number of lesions evaluated, number of lesions with biofilm, detected bacteria, biofilm levels, country where the research was conducted, and the methodological quality of the studies. The meta-analysis was performed using a random effects model in R software (The R Foundation for Statistical Computing).

Results: A total of 281 articles were retrieved; after applying the reading and exclusion criteria, 24 studies were included. The meta-analysis incorporated 24 studies from 12 countries, evaluating 2666 lesions with a biofilm prevalence of 68% (95% CI, 58%-79%; I² = 92%). A high prevalence was observed in Asian publications (73%; 95% CI, 62%-84%; I² = 98%), with of Staphylococcus aureus (71%; 95% CI, 51%-90%; I² = 98%) and Pseudomonas aeruginosa (65%; 95% CI, 47%-82%; I² = 98%) being the most common found in all publications.

Conclusions: Despite the methodological heterogeneity of the studies included in this review, the findings indicate a high prevalence of biofilms in chronic wounds presented in the studies that made up the sample.

Background: Charcot foot is a debilitating complication of peripheral neuropathy and is primarily associated with diabetes, leading to structural damage, ulceration, and osteomyelitis. Pulsed electromagnetic field (PEMF) therapy is a promising treatment modality for wound healing and bone metabolism.

Objective: To evaluate the efficacy of PEMF therapy in promoting bone growth and ulcer healing in patients with Charcot foot ulcers.

Materials and methods: This prospective, single-blinded, controlled trial included 34 patients with stage 2 or 3 chronic Charcot foot with ulceration who were randomized into 2 groups. Group A (study group) received PEMF therapy in addition to transcutaneous electrical nerve stimulation (conventional TENS), medical treatment, and standard wound care, while group B (control group) received conventional TENS and the same medical treatment and standard wound care as those in group A, 3 times per week for 3 months. Primary outcomes were assessed with plain radiographs and wound surface area tracing pre-intervention, 6 weeks post-intervention, and 12 weeks post-intervention.

Results: No significant differences were evident at baseline analysis. After 6 weeks, both groups showed significant change in Charcot foot signs as well as a reduction in wound surface area (P < .05). In the study group, 23.5% of participants showed complete resolution of Charcot signs (normal appearance), 5.9% progressed to stage 2 (bone sclerosis), and 70.6% remained at stage 1. Regarding wound healing, the study group showed greater reduction in wound surface area, with a median (IQR) of 8.5 cm2 (9.4 cm2-12.2 cm2) compared with 11.5 cm2 (9.4 cm2-15.5 cm2) in the control group. By 12 weeks, 94.1% of the study group showed complete radiological resolution of Charcot signs vs 5.9% in the control group (P < .001). Median wound surface area was significantly reduced in the study group to 0.0 cm² (0.0 cm²-1.0 cm²) compared with 6.6 cm2 (5.7 cm²-7.9 cm²) in the control group (P < .05), indicating superior healing outcomes with PEMF therapy.

Conclusion: PEMF therapy is an efficacious adjunctive treatment for Charcot foot ulcers, facilitating both wound healing and bone regeneration.