In patients with foot ulcers, is negative pressure wound therapy and autologous heterogeneous skin constructs compared with stan
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 terms or combination of terms, Boolean operators,
Any delimiters that were used (i.e. publication year, language)
Which combinations of search terms/delimiters worked well and which did not?
How many articles did you find to be related to the research problem you are reviewing?
Why did you include the two articles for review? Cite each article and give rationale for why that article was chosen within paragraph. Put article on reference list.
Do not use Google Scholar and One Search, they are search engines, not databases.
Remember, you have already completed this section as part of Discussion Board #1
Look at the methods section of a systematic review for an example of discussing search strategy.
I’d rather have students review Eileen Harrington’s video
7
PICO
State your clinical question.
Then identify each component
P (population)
I (intervention – you have been assigned)
C (comparison, if present)
O (outcome)
This is not part of the introduction paragraph.
8
Pulling Paper Together
Finished paper has cover page, content, reference page(s).
Everyone on the team is responsible for the paper.
Duties should be divided (who does which piece)
Need to go back through the entire paper and make sure flows well.
Everyone should proofread entire paper.
One person from team submits into portal. (One submission per team.)
,
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 data collection – self-report, etc.; and finally give the name of the tool used, if applicable, plus any information on reliability and validity) | ||
| Main Results (include mean scores/SD, % and p values on the outcome variable from your PICO) |
Table 1 Content: Objective/Purpose and IV/DV
For maximum point credit, be thorough in your descriptions.
Objective/ Purpose: describe fully, similar to how described in the article (in your own words).
Selected outcome variable (DV): This is the O from your PICO. It is not necessary to include other outcome variables.
Assigned Intervention (IV): Describe how the intervention was conducted and control conditions (what happened to people in the control group).
Table 1 Content: Design, Setting and Sample
Design: Give the name of the design. Include proper terminology and details like length of study and participant activities.
Setting: Describe the setting. Study may not name the actual facility but should tell you general information about it.
Sample: What was the sampling plan? Were there issues with the sampling plan or did adaptations to sample plan need to be made? If so, describe. Was a power analysis done? What did the final sample look like? Give specific information about sample (from Results section usually). Were there differences between the groups?
Table 1 Content: Data Collection Tools and Instruments
Data Collection Tools/ Instruments: If the tool has a name, list it. Then describe the tool, what data was being collected and how. Use appropriate terminology. Was reliability and validity established? If so, what forms of R&V and how were they established? Who collected the data? How were they trained?
Table 1 Content: Main results
Main Results: Describe what the major results of each study were. Report results using means and standard deviations, percentages, p-values and confidence intervals. You are expected to list the tests and results but not expected to interpret them yet (will update for Paper 3)
Narratives
Should be about 1 page for both narratives.
Want to identify at least 2 MAJOR similarities between the 2 studies. Name the similarities, describe them fully. What was the significance of this? Was this similarity a good thing or not so helpful? Why?
Want to identify at least 2 MAJOR differences between the 2 studies. As above, describe fully.
Similarities cannot include population, intervention or outcomes.
In-text citations and references must be done according to APA standards.
,
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 correctly then it could be said that definitive conclusions existed.
Consistent recommendations based on extensive literature review: refer to the literature review, was the review relevant to the study, was the literature current, were there scientific studies included in the review and were they relevant to the study.
Strengths and Weaknesses Narrative
Use the strengths and weaknesses described in the table to write the narrative.
The narrative:
describe each strength and weakness
explain why it is a strength or weakness (how it makes the study strong or weak)
Do not write about more than 2 strengths and 2 weaknesses.
Include citations when necessary
A Note about Strengths and Weaknesses
Statistical significance is not a strength and lack of statistical significance is not a weakness – you will lose points if included in the table
Unequal groups is a weakness, but equal groups is not a strength because groups are expected to be equal
In general, having an inclusion/exclusion criteria is not a strength. A specific criteria that strengthens the study can be considered a strength. Not including a criteria that could strengthen the study would be a weakness. Not having an inclusion criteria is a weakness.
If something is listed as a strength, it cannot be listed as a weakness
Recommendation
Using the JHNEBP ratings and grades for strength and quality of evidence from Table 2 develop a single recommendation for nursing practice based on your analysis and critique of the selected studies.
Write a narrative explaining your recommendation based on the following questions:
Should practicing nurses use the evidence you reviewed to guide their practice? Why or why not?
Was clinical significance demonstrated?
What other factors should be considered before implementing this recommendation?
Feasibility of recommendations – how easy or difficult to implement and why.
Implications for future research – what future research should be conducted.
,
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 ulcer cellulitis and bleeding)
were possibly related to the autologous heterogeneous skin construct. Data
from this planned interim analysis support that application of autologous het-
erogeneous skin construct may be potentially effective therapy for DFUs and
provide supportive data to complete the planned study.
K E Y W O R D S
biological products, diabetic foot, randomised controlled trial, ulcer, wound healing
Received: 17 February 2021 Revised: 28 March 2021 Accepted: 31 March 2021
DOI: 10.1111/iwj.13598
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any
medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
© 2021 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.
64 Int Wound J. 2022;19:64–75.wileyonlinelibrary.com/journal/iwj
1 | INTRODUCTION
Diabetic foot ulcers (DFUs) cost Medicare $6.2–18.7 bil- lion each year and have a devastating annual impact on the economy of United States, with an annual burden of over $50 billion.1,2 Approximately 1.5 million Americans have DFUs, which contribute to 130 000 annual lower- extremity amputations.3,4 A real-world analysis of 62 964 DFUs registered in the US Wound Registry found that their healing rate at 12 weeks was only 30.5%.5 A meta- analysis of DFUs treated in trials with standard of care revealed a 12-week closure rate of 24%.6 Biological skin substitutes are commonly used as adjunctive therapy to improve wound closure.7,8 However, most products are quite costly and require multiple applications. Split- thickness skin grafting (STSG) can contribute new healthy tissue to the wound bed but has a failure rate of approximately 30% when applied to DFUs as a conse- quence of poor graft take by the chronic wound bed, the presence of diabetes, vascular insufficiency, other com- orbidities, and/or bacterial contamination.9-14 As many DFUs are treated in the outpatient setting, another disad- vantage of skin grafting is that it involves a surgical pro- cedure in the operating room.
A novel autologous heterogeneous skin construct (AHSC) created from a small harvest of full thickness, healthy skin may be safe and effective as adjunctive ther- apy in treating complex and refractory wounds.15-24 AHSC is composed of small multicellular segments and contains the endogenous regenerative cellular populations of healthy skin that promote wound closure, so that a single application can regenerate full-thickness, functionally polarised skin on the wound bed.20-25 The manufacturing process of the AHSC retains the endogenous regenerative cellular populations associated with wound healing pre- sent within hair follicles, glands, and the interfollicular epidermis, facilitating engraftment optimisation and wound closure.24 AHSC is not cultured ex vivo, but rather it is expeditiously returned to the provider to be adminis- tered topically over a clean, debrided, viable wound bed and covered with common nonadherent, nonabsorbent dressings in the outpatient setting. The AHSC conforms nicely to the wound and over days forms small skin islands that expand and coalesce across the entire wound bed to close the wound, rather than initiating epithelialisation solely from the wound margin.20,21 In a pilot study of 11 patients with DFUs extending up to the tendon, bone, or capsule, 10 patients closed within 8 weeks of a single application of AHSC, with the mean percent area reduc- tion (PAR) for all wounds at 4 weeks at 83%.24 A larger, controlled trial was needed to confirm these initial findings in DFUs. A planned interim analysis of the first 50 of the 100 patients of a randomised controlled trial (RCT) was
performed to compare the effects of AHSC to standard of care in the treatment of Wagner 1 DFUs.
2 | METHODS
2.1 | Study design and population
This was a planned interim analysis of the first 50 patients of a prospective, multicentre, RCT evaluating wound clo- sure rates of DFUs treated in an outpatient setting. Thir- teen wound care centres in the United States participated in this study. The null hypothesis was the proportion of wounds closed at 12 weeks, after up to 12 weeks of AHSC and standard of care or standard of care alone, would be equal for groups 1 (AHSC + standard of care) and 2 (con- trol). Formally, H0: I1–I2 = 0; HA: I1–I2 = D1 ≠ 0, where I1 was the proportion of wounds closed in group 1, I2 was the same metric for group 2, D1 was the differ- ence (I1–I2); assuming the alternative hypothesis and sta- tistical test used was chi square/Fisher exact test. The primary endpoint was the percentage of index ulcers closed at 12 weeks. Complete closure was defined when 100% epithelialisation without drainage was first observed, followed by a closure confirmation visit
Key Messages
• This interim analysis of an ongoing, random- ised controlled trial evaluated a single applica- tion of autologous heterogeneous skin construct (AHSC) as adjunctive therapy to standard of care in Wagner 1 diabetic foot ulcers compared to standard of care alone in 50 initial subjects.
• There were significantly more wounds closed in the AHSC group (18/25; 72%) compared to the control group (8/25; 32%) (P = .005) and a significantly greater percent area reduction in the AHSC group compared to the control group at each prespecified timepoint of 4 weeks (79% vs 24%, P = .0002), 6 weeks (83% vs 44%, P = .004), 8 weeks (87% vs 47%, P = .002), and 12 weeks (88% vs 50%, P = .012), respectively.
• In the AHSC group, there were no serious adverse events related to the index ulcer or determined to be related to AHSC treatment.
• These data support continuation of the planned study
ARMSTRONG ET AL. 65
2 weeks later. Secondary endpoints included the PAR at 4, 6, 8, and 12 weeks; changes in wound quality-of-life (W-QOL short questionnaire, with each question scored on a scale of 0 = “not at all” to 4 = “very much”); reduced pain (based on the Visual Analogue Scale [VAS], with 0 = no pain and 10 = worst possible pain); improve- ments in peripheral neuropathy by Semmes Weinstein monofilament test; and incidence of adverse events (AEs) and complications.
The sample size was determined to be 102 (51 in each group) to achieve 89% power to detect a difference between the group proportions of 0.3. The proportion in the AHSC group was assumed to be 0.3 under the null hypothesis and 0.6 under the alternative hypothesis. The proportion in the control group was 0.3. The test statistic used was the two-sided Z test with pooled vari- ance. The significance level of the test was targeted at 0.05. The significance level actually achieved by this design was 0.05. Unblinded interim analysis was per- formed after 50 subjects completed the study in order to assess subject outcomes between the groups and to recalculate the sample size for the primary endpoint. This study was conducted according to the principles expressed in the Declaration of Helsinki, and the Insti- tutional Review Board Advarra (Columbia, MD) approved the study protocol. The study protocol was registered on clinicaltrials.gov (NCT03881254).
Adult patients with a Wagner 1 DFU that did not involve the tendon, muscle, or bone, provided that it was below the aspect of the medial malleolus, were screened for study participation. Table 1 details complete inclusion and exclusion criteria. Eligible patients provided their written informed consent and were enrolled into the study. During their first screening visit, their demo- graphics and medical history were recorded; a complete physical examination was performed; laboratory tests were taken; the index ulcer was assessed for infection and pain; adequate perfusion was confirmed; Semmes Weinstein monofilament test for peripheral neuropathy was performed; subjects answered the W-QOL short questionnaire; sharp debridement of the index ulcer was performed as needed; the wounds were dressed with standard of care; and offloading was initiated.
Two weeks after the initial screening visit, subjects returned to undergo the same assessments to check for any changes in their health, ulcer healing status, and eli- gibility. Randomisation occurred if the ulcer did not change in size greater than 30% and still met eligibility. The Organisation1 (City2, State2) used a block size of 10 for randomisation (5 sheets of paper with a standard- of-care assignment and 5 with an AHSC assignment). Each sheet was inserted into an opaque envelope that was sealed. The study coordinator shuffled the envelopes,
while under observation by the principal investigator and staff. After repeating the process 10 times, the envelopes were sent to the study sites, ensuring that site investiga- tors were blinded to the randomisation method and treat- ment assignment. The site investigators enrolled the subjects into the study and were aware of the study group following randomisation.
2.2 | AHSC preparation, application, and follow-up
Following randomisation, standard of care was applied to both groups, and the AHSC group underwent the skin harvest procedure. Standard of care included offloading of the DFU (CAM boots or total contact casting, if the subject's foot was too large for a CAM boot, or per the provider's discretion), appropriate sharp or surgical debridement, collagen alginate and appropriate wound care covering, including 4 × 4 gauze pads, foam, and a multilayer compression ban- daging system comprised a soft roll layer, an elastic layer, and a cohesive bandage layer (Dyna-Flex, KCI, St. Paul, MN).In the AHSC group, a 1 × 2 cm full- thickness harvest of healthy skin was excised from the index limb of each subject using sterile technique and local. The provider sutured closed the harvest site. The harvest was shipped overnight to a Food and Drug Administration–registered biomedical manufacturing facility (PolarityTE, Salt Lake City, UT) and used to manufacture the AHSC (Product, Organisation3). The AHSC was returned to the provider within 48 hours of tissue harvest and applied to the wound within 4 days after the harvesting procedure. The AHSC was shipped and stored at 4�C before application.
On the day of the application procedure, the wound was cleaned and sharply debrided, if required. The AHSC was spread evenly across the wound bed. Next, the wound was dressed with a silicone dressing covered by an absorbent foam dressing (DermaFoam, DermaRite Industries, North Bergen, NJ). A three-layer compression bolster was then applied. Dressings were changed weekly, and wounds continued to be offloaded. At the third follow-up visit, a nonadherent contact layer (Adaptic Touch, KCI) replaced the silicone dressing. After the AHSC was applied and the wound was addressed, a time-out procedure undertaken by the on- site study team confirmed the application of the subject's own harvested construct to the index ulcer.
Subjects in both groups had weekly follow-up visits and dressing changes with standard of care for up to 12 weeks. At each visit, wound sites (including the har- vest sites in the AHSC group) were assessed for healing
66 ARMSTRONG ET AL.
status, pain, and infection; the index ulcer was measured and assessed for graft take; and AEs were reported. A licensed provider who did not treat the index ulcer first performed an initial, blinded wound closure assessment of the wound in-person. Once considered healed by the blinded investigator, the wound images were forwarded to a group of university plastic surgeon adjudicators who determined if the wound was healed within 24 hours of receiving the photographs. If two-thirds of the adjudica- tors agreed that the wound had closed, then the subject returned for a closure confirmation visit 2 weeks later. At the end-of-study visit, W-QOL was also assessed, and a Semmes-Weinstein monofilament test was administered for peripheral neuropathy.
2.3 | Data collection and analysis
Data were stored in an Excel database. The statistical analysis was performed using PASW 27 (IBM, Chicago, IL). Blinded, interim analysis was first performed, and coding for treatment was then applied to the analysis involving comparison of groups.
The intent-to-treat (ITT) and safety populations com- prised randomised subjects who received at least 1 treat- ment. All analyses used the ITT approach. The last observation carried forward principle that was used with regard to missing area data at study visits. Study variables were summarised as means and SDs for continuous vari- ables as well as medians for nonnormal data. Categorical
TABLE 1 Patient inclusion and exclusion criteria
Inclusion criteria
• At least 18 years old • Presence of a Wagner 1 DFU that did not extend through the dermis or subcutaneous tissue and did not involve the tendon, muscle,
or bone, provided that it was below the aspect of the medial malleolus • If two or more Wagner 1 DFUs were present, then the index ulcer was the largest ulcer and the only
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