In patients with foot ulcers, is negative pressure wound therapy and autologous heterogeneous skin constructs compared with standard wound care, effective in increasing rates wound closure

N316 EBP Paper Part 1
Helpful Hints

Paper Basics

This is a formal paper. Follow APA 7 format.

Cover page

Should list each team member in alphabetical order.

References

Cited properly within the paper and on reference list

Full sentences, appropriate grammar & spelling

No contractions

Acronyms spelled out first time

Evidence Based Practice (EBP)

Hypertension (HTN)

APA Resources

APA 7 Publication Manual (Student Guidance)

Tips for Writing in APA 7 under Assignments

APA website:

https://apastyle.apa.org/style-grammar-guidelines

Guidelines lets you query specific topics

Instructional Aids  Handouts and Guides

P

3

Syllabus, B-2 (page 10)

Grading Criteria
 
Points
Introduction contains a topic sentence and wrap-up sentence 1.0
Introduction presents a logical flow of data and sound reasoning that leads to the clinical question 1.0
Introduction shows a clear connection between nursing (or interprofessional practice) and the clinical question 1.0
Introduction cites at least two sources from appropriate (i.e., authoritative and/or peer-reviewed) literature to support claims (other than the 2 articles you are evaluating) 0.5
All four PICO components are clearly identified 0.5
Databases, search terms, Boolean operators and delimiters are identified 0.5
Meets good writing criteria according to the American Psychological Association’s Manual (7th Ed.) – e.g., full sentences, no contractions, acronyms defined first use, no grammatical errors or typos, proper source citation 0.5
Total points 5.0

Paper will be ~ 4 paragraphs of content.

First 1 to 2 paragraphs make a case for this project (significance of the clinical problem). Why does this matter to nurses? Why is this important to do?

Prevalence, outcomes, current state/ gaps in knowledge

Use 2 additional references (NOT your primary articles) to support. Systematic reviews, clinical practice guidelines, CDC, AHRQ, WHO data OK here.

Cite within the paper and on reference list.

Remington’s introduction excellent example

Example of Significance/Background

6

Search Strategy

~ 1 to 2 paragraphs

Include:

Database(s) that were searched (at least 2 including CINAHL)

Search t

N316 EBP Paper Part 2
Helpful Hints

EBP Paper 2: Addendum B-3, pg. 11 Syllabus
Analysis of Research Articles

Encompasses material covered in class to date, through descriptive data (Module 9).

Rubric:

Grading Criteria Points
Table 1 is formatted correctly and content is legible 0.5
Table 1 contains correct and required information 3.0
Narrative discusses at least two key similarities between articles 0.5
Narrative discusses at least two key differences between articles 0.5
Meets good writing criteria according to the American Psychological Association’s Manual (7th Ed.) – e.g., full sentences, no contractions, acronyms defined first use, no grammatical errors or typos, proper source citation 0.5
Total points 5.0

General Information

Still an APA paper.

Needs cover page, references.

In-text references and reference list

Minimum references would be 2 articles used

Do not include EBP Part 1. (Paper 3 will compile all 3 parts together.)

Narrative sections must be written in scholarly style following APA standards.

See APA Resources in Bb

Table 1

Table 1 Formatting

Do not break words in the middle of the word

Information must be summarized from the article

Do not copy and paste from the article

Refer to chapter 3

Information must be included in table format. Cannot just submit information written out in paragraph format or bullet points.

Table 1 Format Example, p 11 Syllabus

Source (1st author, year)    
Objective/ Purpose (describe fully)    
Selected outcome variable (DV) (this is the O from your PICO; do not include other outcomes that the researchers investigated)    
Design (name the design and briefly describe the length of the study – how long could participants expect to be involved with study activities?)    
Setting (describe in as much detail as you can) & Sample (sampling method & include short description of demographics of the final sample and whether a power analysis was conducted)    
Assigned intervention (IV) (you will need to add details here – briefly describe the intervention AND control conditions, if applicable)    
Data Collection Methods, Tools/ Instruments (briefly describe the timing of data collection – how often and when were data collected; name the method of da

N316 EBP Paper Part 3
Helpful Hints

General Information

APA 7 Publication Manual (Student Guidance)

JHNEBP Model should be included in the references

Combine EBP Papers one (1) and two(2), including corrections, with EBP Paper 3.

See Addendum B-4, page 12 of the Syllabus for additional information

Table 2 Content: Addendum B-4, page 13
Strengths and Weaknesses

Use the template for Table 2.

List at least (2) strengths and (2) weakness in the study design, sample or methods for each study.

Not everything is a strength or weakness, see Slide #7

In the first column labeled “Source” include only the first author and year (i.e., Smith, 2020).

In the last column “JHNEBP Score”, list both the level of evidence (rating) and the grade (quality)

Table 2 Content: Addendum B-5, page 14 of 19
Rating and Grading the Evidence

Use the Johns Hopkins Nursing Evidence-Based Practice Model in Addendum B-5 to rate the research design (Level) and grade the quality of the evidence.

Rate the level of evidence I-V based on the type of research design.

LEVELS

I: Evidence from experimental study, RCT, or meta-analysis of RCTs

II: Evidence from quasi experimental study

III: Evidence obtained from a non-experimental study, qualitative study or meta-synthesis (qualitative study synthesis)

IV: Opinion of nationally recognized experts based on research evidence or expert consensus panel (systematic review, clinical practice guidelines)

V: Opinion of individual expert based on non-research evidence. (Includes case studies; literature review; organizational experience e.g., quality improvement and financial data; clinical expertise, or personal experience)

Table 2 Content: Addendum B-5, page 14 of 19
Rating and Grading the Evidence

Use the Johns Hopkins Nursing Evidence-Based Practice Model in Addendum B-5 to rate the research design (Level) and grade the quality of the evidence.

Grade the quality of evidence A – High, B – Good, C – Low/major flaw based on the criteria.

Consistent, generalizable results: Are the study findings consistent with other studies on the topic (see Discussion), and are the results generalizable to people with the same issue but different characteristics?

Sufficient sample: Is the sample size sufficient? If so, how do you know? Was a power analysis used? Was the sample size based on previous research?

Adequate control: Was the environment controlled, was their blinding, were the groups similar, were researchers and assistants trained on administering the intervention?

Definitive conclusions: If adequate control, with strong study design and statistical analysis, and the intervention was administered corre

O R I G I N A L A R T I C L E

A multicentre, randomised controlled clinical trial
evaluating the effects of a novel autologous, heterogeneous
skin construct in the treatment of Wagner one diabetic foot
ulcers: Interim analysis

David G. Armstrong1 | Dennis P. Orgill2 | Robert Galiano3 | Paul M. Glat4 |

Lawrence Didomenico5 | Alexander Reyzelman6 | Robert Snyder7 |

William W. Li8 | Marissa Carter9 | Charles M. Zelen10

1Department of Surgery, University of
Southern California, Keck School of
Medicine, Los Angeles, California
2Division of Plastic Surgery, Brigham and
Women’s Hospital, Boston, Massachusetts
3Division of Plastic Surgery, Northwestern
University Feinberg School of Medicine,
Chicago, Illinois
4Drexel University, Philadelphia,
Pennsylvania
5Lower Extremity Institute of Research
and Therapy, Youngstown, Ohio
6Center for Clinical Research, San
Francisco, California
7Clinical Research Barry University SPM,
Brand Research Center, Barry University,
Miami, Florida
8The Angiogenesis Foundation,
Cambridge, Massachusetts
9Strategic Solutions, Bozeman, Montana
10Department of Medical Education, The
Professional Education and Research
Institute (PERI), Roanoke, Virginia

Correspondence
Charles M. Zelen, DPM, Department of
Medical Education, The Professional
Education and Research Institute,
222 Walnut Ave., Roanoke, VA 24016.
Email: [email protected]

Funding information
Polarity TE, Grant/Award Number: 002

Abstract

We desired to carefully evaluate a novel autologous heterogeneous skin con-

struct in a prospective randomised clinical trial comparing this to a standard-

of-care treatment in diabetic foot ulcers (DFUs). This study reports the interim

analysis after the first half of the subjects have been analysed. Fifty patients

(25 per group) with Wagner 1 ulcers were enrolled at 13 wound centres in the

United States. Twenty-three subjects underwent the autologous heterogeneous

skin construct harvest and application procedure once; two subjects required

two applications due to loss of the first application. The primary endpoint was

the proportion of wounds closed at 12 weeks. There were significantly more

wounds closed in the treatment group (18/25; 72%) vs controls (8/25; 32%) at

12 weeks. The treatment group achieved significantly greater percent area

reduction compared to the control group at every prespecified timepoint of

4, 6, 8, and 12 weeks. Thirty-eight adverse events occurred in 11 subjects (44%)

in the treatment group vs 48 in 14 controls (56%), 6 of which required study

removal. In the treatment group, there were no serious adverse events related

to the index ulcer. Two adverse events (index

1Seidel D, et al. BMJ Open 2020;10:e026345. doi:10.1136/bmjopen-2018-026345

Open access

Negative pressure wound therapy
compared with standard moist wound
care on diabetic foot ulcers in real- life
clinical practice: results of the
German DiaFu- RCT

Dörthe Seidel ,1 Martin Storck,2 Holger Lawall,3,4 Gernold Wozniak,5
Peter Mauckner,6 Dirk Hochlenert,7 Walter Wetzel- Roth,8 Klemens Sondern,9
Matthias Hahn,10 Gerhard Rothenaicher,11 Thomas Krönert,12 Karl Zink,13
Edmund Neugebauer14,15

To cite: Seidel D, Storck M,
Lawall H, et al. Negative
pressure wound therapy
compared with standard
moist wound care on diabetic
foot ulcers in real- life clinical
practice: results of the
German DiaFu- RCT. BMJ Open
2020;10:e026345. doi:10.1136/
bmjopen-2018-026345

► Prepublication history and
additional material for this
paper are available online. To
view these files, please visit
the journal online (http:// dx. doi.
org/ 10. 1136/ bmjopen- 2018-
026345).

Received 28 August 2018
Revised 15 January 2020
Accepted 16 January 2020

For numbered affiliations see
end of article.

Correspondence to
Ms Dörthe Seidel;
Doerthe. Seidel@ uni- wh. de

Original research

© Author(s) (or their
employer(s)) 2020. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published by
BMJ.

AbstrACt
Objectives The aim of the DiaFu study was to evaluate
effectiveness and safety of negative pressure wound
therapy (NPWT) in patients with diabetic foot wounds in
clinical practice.
Design In this controlled clinical superiority trial with
blinded outcome assessment patients were randomised in
a 1:1 ratio stratified by study site and ulcer severity grade
using a web- based- tool.
setting This German national study was conducted in 40
surgical and internal medicine inpatient and outpatient
facilities specialised in diabetes foot care.
Participants 368 patients were randomised and 345
participants were included in the modified intention-
to- treat (ITT) population. Adult patients suffering from
a diabetic foot ulcer at least for 4 weeks and without
contraindication for NPWT were allowed to be included.
Interventions NPWT was compared with standard moist
wound care (SMWC) according to local standards and
guidelines.
Primary and secondary outcome measures Primary
outcome was wound closure within 16 weeks. Secondary
outcomes were wound- related and treatment- related
adverse events (AEs), amputations, time until optimal
wound bed preparation, wound size and wound tissue
composition, pain and quality of life (QoL) within 16 weeks,
and recurrences and wound closure within 6 months.
results In the ITT population, neither the wound closure
rate (difference: n=4 (2.5% (95% CI−4.7% – 9.7%);
p=0.53)) nor the time to wound closure (p=0.244) was
significantly different between the treatment