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A phase 2B randomised trial of hyperbaric oxygen therapy for ulcerative colitis patients hospitalised for moderate to severe flares

Dulai, Parambir S; Raffals, Laura E; Hudesman, David; Chiorean, Michael; Cross, Raymond; Ahmed, Tasneem; Winter, Michael; Chang, Shannon; Fudman, David; Sadler, Charlotte; Chiu, Ernest L; Ross, Frank L; Toups, Gary; Murad, M Hassan; Sethuraman, Kinjal; Holm, James R; Guilliod, Renie; Levine, Benjamin; Buckey, Jay C; Siegel, Corey A
BACKGROUND:Hyperbaric oxygen has been reported to improve disease activity in hospitalised ulcerative colitis (UC) patients. AIM/OBJECTIVE:To evaluate dosing strategies with hyperbaric oxygen for hospitalised UC patients. METHODS:We enrolled UC patients hospitalised for acute flares (Mayo score 6-12). Initially, all patients received 3 days of hyperbaric oxygen at 2.4 atmospheres (90 minutes with two air breaks) in addition to intravenous steroids. Day 3 responders (reduction of partial Mayo score ≥ 2 points and rectal bleeding score ≥ 1 point) were randomised to receive a total of 5 days vs 3 days of hyperbaric oxygen. RESULTS:We treated 20 patients with hyperbaric oxygen (75% prior biologic failure). Day 3 response was achieved in 55% (n = 11/20), with significant reductions in stool frequency, rectal bleeding and CRP (P < 0.01). A more significant reduction in disease activity was observed with 5 days vs 3 days of hyperbaric oxygen (P = 0.03). Infliximab or colectomy was required in only three patients (15%) despite a predicted probability of 80% for second-line therapy. Day 3 hyperbaric oxygen responders were less likely to require re-hospitalisation or colectomy by 3 months vs non-responders (0% vs 66%, P = 0.002). No treatment-related adverse events were observed. CONCLUSION/CONCLUSIONS:Hyperbaric oxygen appears to be effective for optimising response to intravenous steroids in UC patients hospitalised for acute flares, with low rates of re-hospitalisation or colectomy at 3 months. An optimal clinical response is achieved with 5 days of hyperbaric oxygen. Larger phase 3 trials are needed to confirm efficacy and obtain labelled approval.
PMID: 32745306
ISSN: 1365-2036
CID: 4559982

Management of stage 0 medication-related osteonecrosis of the jaw with hyperbaric oxygen therapy: a case report and review of the literature

Lin, Lawrence J; Alfonso, Alison R; Ross, Frank L; Chiu, Ernest S; Fleisher, Kenneth E
The definition of medication-related osteonecrosis of the jaw (MRONJ) includes a stage 0 presentation where exposed bone, the hallmark of this condition, is absent. Numerous management strategies have been recommended for MRONJ including hyperbaric oxygen (HBO2) therapy. This report describes a 64-year-old woman with stage 0 MRONJ of the bilateral mandible, refractory to clindamycin and local debridement, who was subsequently managed successfully with amoxicillin/clavulanate and HBO2 therapy. The authors also explore the current literature on the pathophysiology of MRONJ and the potential role of hyperbaric oxygen in its treatment.
PMID: 32574441
ISSN: 1066-2936
CID: 4511882

A Descriptive Revenue Analysis of a Wound-Center IR Collaboration to Treat Lower Extremity Venous Ulcers

Ruohoniemi, David M; Ross, Frank L; Chiu, Ernest S; Taslakian, Bedros; Horn, Jeremy C; Aaltonen, Eric A; Kulkarni, Kopal; Browning, Alexa; Patel, Amish; Sista, Akhilesh K
PURPOSE/OBJECTIVE:To describe the revenue from a collaboration between a dedicated wound care center and an interventional radiology (IR) practice for venous leg ulcer (VLU) management at a tertiary care center. MATERIALS AND METHODS/METHODS:This retrospective study included 36 patients with VLU referred from a wound care center to an IR division during the 10-month active study period (April 2017 to January 2018) with a 6-month surveillance period (January 2018 to June 2018). A total of 15 patients underwent endovascular therapy (intervention group), whereas 21 patients did not (nonintervention group). Work relative value units (wRVUs) and dollar revenue were calculated using the Centers for Medicare and Medicaid Services Physician Fee Schedule. RESULTS:Three sources of revenue were identified: evaluation and management (E&M), diagnostic imaging, and procedures. The pathway generated 518.15 wRVUs, translating to $37,522. Procedures contributed the most revenue (342.27 wRVUs, $18,042), followed by E&M (124.23 wRVUs, $8,881), and diagnostic imaging (51.65 wRVUs, $10,599). Intervention patients accounted for 86.7% of wRVUs (449.48) and 80.0% of the revenue ($30,010). An average of 33 minutes (38.3 hours total) and 2.06 hours (36.8 hours total) were spent on E&M visits and procedures, respectively. CONCLUSIONS:In this collaboration between the wound center and IR undertaken to treat VLU, IR and E&M visits generated revenue and enabled procedural and downstream imaging revenue.
PMID: 31623925
ISSN: 1535-7732
CID: 4140652

Refractory Ulcerated Necrobiosis Lipoidica: Closure of a Difficult Wound with Topical Tacrolimus

Ginocchio, Luke; Draghi, Lisa; Darvishian, Farbod; Ross, Frank L
OBJECTIVE: To report a case of refractory ulcerated necrobiosis lipoidica (NL) with significant response to treatment with topical tacrolimus. SUBJECT: A 55-year-old woman without diabetes and with a previous history of NL presented to the Helen L. and Martin S. Kimmel Hyperbaric and Advanced Wound Healing Center of NYU Langone Medical Center, New York, with bilateral lower-leg ulcerations resistant to wound healing techniques at other institutions. MATERIALS AND METHODS: Repeat biopsy performed at the author's institution confirmed the diagnosis of NL. Initial therapy was based on reports of other successful treatment methods, which included collagen wound grafts and collagen-based dressings coupled with compression. These methods initially showed promising results; however, the wounds reulcerated, and any gains in wound healing were lost. Alternative options were initiated, including topical clobetasol and narrowband ultraviolet B; however, no significant improvement was observed. The patient's lower-extremity wounds began to deteriorate. The patient also refused systemic therapy. Treatment was changed to topical 0.1% tacrolimus ointment and was applied daily for 10 months with multilayer compression wraps. RESULTS: Both lower-extremity ulcerations began to show significant improvement, with the ulcers progressing toward closure except for 1 very small area on the left lower extremity. CONCLUSIONS: Topical tacrolimus seems to be an effective treatment option for patients with refractory chronic ulcerated NL who do not want systemic oral therapy. The authors found that successful wound closure may require a multimodal approach, which promotes wound healing, but also concurrently addresses the underlying disease process.
PMID: 28914682
ISSN: 1538-8654
CID: 2701322

Nonhealing Ulcers in Patients with Tophaceous Gout: A Systematic Review

Lam, Gretl; Ross, Frank L; Chiu, Ernest S
GENERAL PURPOSE: To provide information from a review of the literature about chronic ulcers associated with tophaceous gout. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant should be better able to:1. Identify the pathophysiology of tophaceous gout, its presentation, phases, and common comorbidities.2. Evaluate the findings in this review regarding effectiveness of interventions for chronic tophaceous ulcers. ABSTRACT: OBJECTIVE: Treating chronic ulcers associated with tophaceous gout is an uncommon but important clinical challenge. However, treatments vary greatly from topical therapies, to debridements, to free flap wound coverage. To the authors' knowledge, this is the first study to assemble and compare these different approaches in order to guide effective treatment. DATA SOURCES: An electronic search of MEDLINE (PubMed) was conducted. Search terms included (gout and ulcer) not "peptic ulcer," and (gout, chronic wound) or (gout, nonhealing wound). STUDY SELECTION: Studies that discussed the presentation, characterization, or treatment of gout-associated wounds were included. The literature search yielded 9 case reports and case series; there were no randomized controlled studies or reviews. DATA EXTRACTION: Patient and wound characteristics, treatment approaches, and outcomes were noted. DATA SYNTHESIS: The 82% of 22 patients were male, aged 36 to 95 years. Three patients had not been previously diagnosed with gout, whereas others had received a diagnosis 2 to 35 years prior to presentation with an ulcer. Many patients had comorbidities including diabetes and peripheral vascular disease. Most of the 43 total ulcers occurred on the feet. Treatments included topical 3% citric acid in petroleum jelly, allogeneic culture dermal substitute, silver-containing dressing and heterologous lyophilized collagen, debridements, and free flap coverage. CONCLUSIONS: Chronic tophaceous wounds are a worldwide problem. Although physicians report some successes with different treatments, controlled studies are needed to determine the most effective approach and to identify risk factors and preventive strategies.
PMID: 28426572
ISSN: 1538-8654
CID: 2543642

Hyperbaric Oxygen Therapy: Exploring the Clinical Evidence

Lam, Gretl; Fontaine, Rocky; Ross, Frank L; Chiu, Ernest S
GENERAL PURPOSE: To provide information about hyperbaric oxygen therapy (HBOT), its mechanisms, indications and safe applications based on clinical evidence. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant should be better able to:1. Recall the physiology of wound healing and the mechanisms of action of HBOT.2. Identify current applications of HBOT based on clinical evidence as well as its risks and contraindications. ABSTRACT: Treating chronic wounds and infections are challenging medical problems worldwide. Hyperbaric oxygen therapy (HBOT), the administration of 100% oxygen at pressures greater than 1.4 atmosphere absolute in a series of treatments, can be used as an adjunctive therapy in many wound care settings because it improves oxygenation and neovascularization and decreases inflammation in chronic wounds. A growing number of studies support the benefits of HBOT for enhancing wound healing and decreasing the likelihood of negative events such as amputation. However, many practitioners are unfamiliar with HBOT. This article provides a general introduction to HBOT, reviews the physiology and mechanisms of behind HBOT, discusses all the indications for HBOT, and explores in-depth the clinical evidence for HBOT in the treatment of arterial insufficiencies, diabetic ulcers, delayed radiation injury, and chronic refractory osteomyelitis.
PMID: 28301358
ISSN: 1538-8654
CID: 2494312

Wounds in Patients with HIV

McMeeking, Alexander; Kim, In; Ross, Frank; Ayello, Elizabeth A; Brem, Harold; Linton, Patrick; O'Neill, Daniel K
Highly active antiretroviral therapy has dramatically reduced morbidity and mortality among patients who are HIV-positive. A retrospective review of the authors' data separated subjects into cohorts based on HIV status and matched them for age and gender. The authors' data reveal a higher fraction of venous ulcers compared with a lower fraction of pressure ulcers in the seropositive population.
PMID: 25133341
ISSN: 1527-7941
CID: 1132102

A histopathologic basis for surgical debridement to promote healing of venous ulcers

Blumberg, Sheila N; Maggi, Jason; Melamed, Jonathan; Golinko, Michael; Ross, Frank; Chen, Weiliam
BACKGROUND: Pathologic analysis of deep tissue obtained during debridement of venous ulcers is often unnoticed in its importance. We previously reported pathologic findings on 139 patients with venous ulcers. The objective of this study was to correlate the pathologic findings in venous ulcers with wound healing to establish a negative margin for debridement. STUDY DESIGN: Consecutive patients with a lower extremity venous ulcer present for at least 4 weeks, presenting to a single wound healing center, were included. Wounds underwent aggressive surgical debridement beyond the subcutaneous level until judged to have a viable base. Specimens were scored based on cellularity, vascularity, collagen composition, inflammation, and dense fibrosis, with a highest possible score of 13. Healing was the primary outcome for analysis. RESULTS: Of the 26 patients who met inclusion criteria, only 50% of them (13 patients) with a total of 18 venous ulcers underwent surgical debridement available for pathologic analysis. Mean ulcer area was 34.7 cm(2) at initial presentation, and 89% of patients had a continuous positive healing curve as measured by decreasing wound area (from 34.7 cm(2) to 14.3 cm(2)). However, specimens with dense fibrosis, decreased cellularity, mature collagen, and pathology score less than 10 were predominantly nonhealing ulcers. CONCLUSIONS: Presence of dense fibrosis and high levels of mature collagen in deep tissue specimens are significant correlative factors in nonhealing of venous ulcers. We recommend deep debridement on all venous ulcers that are refractory to healing until the level of absence of dense fibrosis and mature collagen is reached to promote venous ulcer healing.
PMID: 22981433
ISSN: 1072-7515
CID: 182442

A multidisciplinary team approach to hydroxyurea-associated chronic wound with squamous cell carcinoma

Stone, T; Berger, A; Blumberg, S; O'Neill, D; Ross, F; McMeeking, A; Chen, W; Pastar, I
Hydroxyurea (HU) has been shown to induce a variety of cutaneous adverse reactions, including severe leg ulcers. This report shows a successful treatment of a HU-induced chronic wound associated with squamous cell carcinomas (SCC). A 62-year-old patient affected with polycythemia vera and treated with HU for 10 years, presented with a non healing ulcer on a left heel. The patient gave a history of suffering from the wound for over 2 years. Biopsy showed evidence of invasive SCC. The patient underwent Mohs surgery and a greater saphenous vein ablation for polycythemia vera-associated vascular complications. The wound consistently decreased in size following successive debridements and coverage with human skin equivalent. The wound healed completely after a 6-month period. A multidisciplinary team approach to the treatment proved to be effective resulting in healing of this multifactorial chronic ulcer.
PMID: 22099725
ISSN: 1742-4801
CID: 159112

Management of gastric outlet obstruction caused by ovarian cancer [Case Report]

Mann, W J; Calayag, P T; Muffoletto, J P; Ross, F; Chalas, E; Deitch, J
Three patients with ovarian cancer who developed gastric outlet obstruction due to loculated ascites in the lesser omental sac are presented. Surgical decompression was utilized, in one case with significant morbidity. Percutaneous drainage under CT or ultrasound guidance allows palliation and avoids potential morbidity and prolonged hospitalization and can be repeated if the condition recurs.
PMID: 2013454
ISSN: 0090-8258
CID: 3459992