Controversies in performing a randomized control trial and a systemic review

Gottrup, Finn

doi:10.1111/j.1524-475x.2012.00805.x

Cited by 3 publications

(5 citation statements)

References 7 publications

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“…There is constant tension between the production of high quality evidence for novel, cost-effective, wound care technology dressings and the generalizability of these studies (and their utility for wound care practitioners) 14. For example, despite the literature describing highest DFU healing rates and lowest times to heal associated with use of total contact casts, these are rarely used in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…In a survey of over 900 US wound care centers, Wu and colleagues52 found <2% of practices used total contact casts in the treatment of the majority of their DFU patients. Several other authors have pointed out the discrepancies between patient populations studied in DFU studies versus those treated in clinical practice 4,5,14,18,53. As Boulton and Armstrong point out,18 most DFUs will heal when offloading is used and ischemia and infection are treated.…”

Section: Discussionmentioning

confidence: 99%

“…Papers were considered for inclusion if they were published in English, were human studies, enrolled DFU patients, and used a collagen-based dressing. Cohort studies were also included in response to current recommended strategies for systematic reviews of wound healing 14. We also expanded our review to include any discussion of any wound care product that contained collagen (as opposed to being exclusively constructed of collagen) 15,16.…”

Section: Methodsmentioning

confidence: 99%

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Collagen-based wound dressings for the treatment of diabetes-related foot ulcers: a systematic review

Holmes¹,

Wrobel²,

MacEachern³

et al. 2013

DMSO

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BackgroundDiabetic foot ulcers are a major source of morbidity, limb loss, and mortality. A prolonged inflammatory response, extracellular matrix degradation irregularities, and increased bacteria presence have all been hypothesized as major contributing factors in the delayed healing of diabetic wounds. Collagen components such as fibroblast and keratinocytes are fundamental to the process of wound healing and skin formation. Wound dressings that contain collagen products create a biological scaffold matrix that supports the regulation of extracellular components and promotes wound healing.MethodsA systematic review of studies reporting collagen wound dressings used in the treatment of Diabetic foot ulcers was conducted. Comprehensive searches were run in Ovid MEDLINE, PubMed, EMBASE, and ISI Web of Science to capture citations pertaining to the use of collagen wound dressings in the treatment of diabetic foot ulcers. The searches were limited to human studies reported in English.ResultsUsing our search strategy, 26 papers were discussed, and included 13 randomized designs, twelve prospective cohorts, and one retrospective cohort, representing 2386 patients with diabetic foot ulcers. Our design was not a formal meta-analysis. In those studies where complete epithelialization, 58% of collagen-treated wounds completely healed (weighted mean 67%). Only 23% of studies reported control group healing with 29% healing (weighted mean 11%) described for controls.ConclusionCollagen-based wound dressings can be an effective tool in the healing of diabetic foot wounds. The current studies show an overall increase in healing rates despite limitations in study designs. This study suggests that future works focus on biofilms and extracellular regulation, and include high risk patients.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Collagen-based wound dressings for the treatment of diabetes-related foot ulcers: a systematic review

Holmes¹,

Wrobel²,

MacEachern³

et al. 2013

DMSO

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“…Chronic wound repair is a complex process, although the patients with venous leg ulcers who were recruited for this experimental evaluation were considered representative of chronic wound pathophysiology and previous treatment (20). The presence of polymicrobial biofilms in wounds leads to an increased release of pro-inflammatory cytokines, enhanced matrix metalloproteinase activity and an inhibition of keratinocyte migration and adhesivity.…”

Section: Discussionmentioning

confidence: 99%

Light‐activated nanofibre textiles exert antibacterial effects in the setting of chronic wound healing

Arenberger

Bednár

Kubát

et al. 2012

Experimental Dermatology

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The maintenance of an aseptic environment for chronic wounds is one of the most challenging tasks in the wound-healing process. Furthermore, the emergence of antibiotic-resistant bacterial strains is on the rise, rendering conventional treatments less effective. A new antibacterial material consisting of a polyurethane Tecophilic(™) nanofibre textile (NT) that was prepared by electrospinning and doped by a tetraphenylporphyrin (TPP) photosensitizer activated by visible light was tested for use in wound beds and bandages. In vitro experiments were performed to assess the antibacterial activity of the textile against three bacterial strains. Furthermore, the new textile was tested in 162 patients with chronic leg ulcers. A complete inhibition of in vitro growth of the three tested bacterial strains was observed on the surface of NTs that had been illuminated with visible light and was clinically demonstrated in 89 patients with leg ulcers. The application of the textiles resulted in a 35% decrease in wound size, as assessed via computer-aided wound tracing. Wound-related pain, which was estimated using a visual analogue scale, was reduced by 71%. The results of this trial reveal that the photoinactivation of bacteria through the photosensitized generation of short-lived, highly reactive singlet oxygen O(2) ((1) Δ(g) ) results in relatively superficial antibacterial effects in comparison with standard antiseptic treatment options. Thus, such treatment does not interfere with the normal healing process. This method therefore represents a suitable alternative to the use of topical antibiotics and antiseptics and demonstrates potentially broad applications in medicine.

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“…In addition to these difficulties, the endpoints of a clinical study may be difficult to define. 13 Nonhealing wounds are a major clinical problem, and the requirements for performing a proper randomized controlled trial are enormous. There are many challenges that researchers should consider in planning the study.…”

Section: Problems In Clinical Wound-healing Researchmentioning

confidence: 99%

Human Wound-Healing Research: Issues and Perspectives for Studies Using Wide-Scale Analytic Platforms

Nuutila

Katayama

Vuola

et al. 2014

Advances in Wound Care

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Controversies in performing a randomized control trial and a systemic review

Cited by 3 publications

References 7 publications

Collagen-based wound dressings for the treatment of diabetes-related foot ulcers: a systematic review

Collagen-based wound dressings for the treatment of diabetes-related foot ulcers: a systematic review

Light‐activated nanofibre textiles exert antibacterial effects in the setting of chronic wound healing

Human Wound-Healing Research: Issues and Perspectives for Studies Using Wide-Scale Analytic Platforms

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