[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)]
[Notices]
[Pages 14945-14946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07302]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Skin Substitutes for 
Treating Chronic Wounds

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Skin Substitutes 
for Treating Chronic Wounds, which is currently being conducted by the 
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before May 13, 2019.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency 
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice 
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC 
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 
20857

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Skin Substitutes for 
Treating Chronic Wounds. AHRQ is conducting this systematic review 
pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 
299a(a).
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Skin Substitutes for Treating Chronic Wounds, including 
those that describe adverse events. The entire research protocol, 
including the key questions, is also available online at: https://www.ahrq.gov/research/findings/ta/index.html.
    This is to notify the public that the EPC Program would find the 
following information on Skin Substitutes for Treating Chronic Wounds 
helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, please provide a summary, including the following 
elements: Study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC Program. 
Materials submitted must be publicly available or able to be made 
public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.

[[Page 14946]]

    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

The Key Questions

    1. What skin substitutes currently used to treat chronic wounds are 
being regulated by the U.S. Food and Drug Administration (FDA) under 
the following pathways: Premarket Approval (PMA), Premarket 
Notification (510[k]), Section 361 of the Public Health Service Act (21 
CFR 1270 and 1271)?
    2. What classification systems have been developed to categorize 
skin substitutes?
    a. What are important skin substitute parameters and active 
components currently being used when classifying skin substitutes?
    3. What are the study design characteristics (such as those listed 
below) in each included investigation for each chronic wound type?

a. Comparator to skin substitute
b. Inclusion/exclusion criteria of patients including at least age, 
gender, and general health requirements (e.g., status of HbA1c, 
diabetes, peripheral vascular disease, obesity, smoking, renal)
c. Inclusion/exclusion criteria of wounds including at least wound 
type, wound size/depth/duration/severity, vascular status, infection 
status, and prior treatment requirements (e.g., no treatment with 
growth factors or negative pressure wound therapy)
d. Patient characteristics of enrollees including at least age, gender, 
general health (e.g., status of HbA1c, diabetes, peripheral vascular 
disease, obesity, smoking, renal), and prior and concurrent wound 
treatments
e. Wound characteristics of enrollees including at least wound type, 
wound size/depth/duration/severity, vascular status, and infection 
status
f. Basic study design and conduct information including at least method 
of patient enrollment, care setting, and use of run-in period
g. Definition of wound characteristics: definition of ``failure to 
heal'', and definition of a successfully healed wound
h. Method of applying skin substitutes including provider, frequency of 
application, definition of standard of care, and handling of infections
i. Measurement and assessment methods including method of 
assessment(s); frequency and time points for assessment(s); and 
blinding of assessors
j. Statistical methods including power calculations, intent-to-treat 
analysis for studies designed to test superiority, and handling of 
drop-outs

    4. What are the outcomes of treatment strategies including skin 
substitutes alone and/or in addition to other wound care modalities 
compared to other wound care modalities in patients with different 
types of chronic wounds, for patient oriented outcomes such as the 
following? Consider at least:

a. Number/percentage of completely closed/healed wounds (skin closure 
with complete re-epithelialization without drainage or dressing 
requirements versus failure to heal)
b. Time to complete wound closure
c. Wound reoccurrence (include time when initial wound healing was 
measured, and follow-up to assess durability of healed wounds)
d. Wound infection
e. Need for amputation
f. Need for hospitalization (frequency and duration)
g. Return to baseline activities of daily living and function
h. Pain reduction
i. Exudate and odor reduction
j. Adverse effects (besides those above)

    5. What skin substitutes are currently being investigated in 
ongoing trials?
    6. What best practices in study design could be used to produce 
high quality evidence on skin substitutes?

Gopal Khanna,
Director.
[FR Doc. 2019-07302 Filed 4-11-19; 8:45 am]
 BILLING CODE 4160-90-P