Rapid Response Survey for "Negative Pressure Wound Therapy Device Used in the Home Environment"

NPWT Online Survey Questionnaire

Paperwork Reduction Act Statement -- OMB number 0910-0500; expiration 1/31/2011

Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the address below.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer (HFA-710) 5600 Fishers Lane Rockville, MD 20857

[Please do NOT return this form to the above address, except as it pertains to comments on the burden estimate.]

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

1. Please select the clinical setting that best describes your affiliation or place of employment.

-- Hospital

-- Independent home health agency

-- Home health agency affiliated with hospital

-- Hospice
-- Nursing home

-- Private practice

-- Other _________

2. What makes and models of negative pressure wound therapy systems (NPWT) does your organization use? Please check all that apply.

Manufacturer	Trade/Brand Names	Check
Blue Sky Medical Group (Blue Sky Medical Group is now owned by Smith & Nephew, Inc.)	V1STA Negative Wound Therapy (portable unit)
	EZCARE Negative Wound Therapy (stationary unit)
	Unsure of brand name
Boehringer Wound Systems, LLC	Engenex® Advanced NPWT System
Innovative Therapies Inc.	SVEDMAN™ Wound Treatment Systems
	SVED™ Wound Treatment System
	Unsure of brand name
Kalypto Medical	NPD 1000 Negative Pressure Wound Therapy System
KCI, USA Inc. (Kinetic Concepts, Inc.)	InfoV.A.C.® Therapy Unit (stationary unit)
	ActiV.A.C.® Therapy Unit (portable unit)
	V.A.C.® Freedom™
	V.A.C.® ATS™
	V.A.C.® Instill System (delivery of topical solutions)
	Unsure of brand name
Premco Medical Systems, Inc.	Prodigy™ NPWT System (PMS-800)
	Prodigy™ NPWT System (PMS-800V)
	Unsure of brand name
Prospera (Prospera Technologies LLC owns the Prospera NPWT systems and brand)	PRO-I™ (stationary and portable)
	PRO-II™ (portable)
	PRO-III™(stationary and portable)
	Unsure of brand name
Smith & Nephew, Inc.	V1STA Negative Pressure Wound Therapy (portable unit)
	EZCARE Negative Pressure Wound Therapy (stationary unit)
	RENASYS™ EZ Negative Pressure Wound Therapy
	Unsure of brand name
Talley Group, Ltd.	Venturi™ Negative Pressure Wound Therapy (portable or stationary)

• Device performance and experience

3. Have you or your patients experienced any of the following issues with the NPWT system(s) your organization uses? Please check all that apply.

• Dressing’s foam adhered to or imbedded in the wound

• Foreign body (dressing’s foam pieces) retained in the wound

• Bleeding  

• Infection

• Vascular graft failure due to improper system function

• Death

• Other, specify: __________________

• None of the above

• Don’t know

 4a. As far as you know, have any of the wound therapy systems your organization uses resulted in better patient outcomes, i.e., better wound healing, no infection?

YES (Go to Q4b)

NO (Go to Q5)

4b. Which system(s) have resulted in better patient outcomes?

SHORT ANSWER

5. For which conditions or diagnoses is NPWT prescribed? Please check all that apply.

Chronic and Acute Wounds

• Diabetic foot ulcers

• Pressure ulcers

• Vascular ulcers (venous and arterial ulcers)

• Burn wounds

• Surgical wounds (sternal wounds)

• Trauma-induced wounds

• Abdominal wound closure

• Excised wounds

• Deep abrasions

Subacute wounds

• Dehiscence

• Open wounds

• Skin grafts

• Skin flaps

Other, specify:

PROGRAMMING NOTE: IF Q1=HOSPITAL, SKIP TO Q14a.

6. Do you have patients who are receiving NPWT, either in the home setting, a nursing home, or in a long-term care facility?

YES (Go to Q7)

NO (Go to Q14a)

7. Do patients or their caregivers express concern about using these systems themselves in the home?

Patients only (Go to Q8)

Caregivers only (Go to Q8)

Both patients and caregivers express concern (Go to Q8)

No concerns expressed by either patient or caregiver (Go to Q9a)

8. What are some of the questions or concerns you typically hear or are aware of?

• Understanding how to use and operate device (in the home)

• Troubleshooting the device

• Alarm issues

• Monitoring patients in the home

• Identifying signs and symptoms of an infection

• How to handle bleeding

• Concerns about changing the dressing

• Concerns about cleaning the wound

• Pain concerns

• Questions about check-ups

• Questions about medications, i.e. dosing, side effects, frequency of administration

• Pressure settings

• Other, specify: ________

9a. Is material provided to the patient or caregiver at discharge that is specific to the NPWT system?

YES (Go to Q9b)

NO (Go to Q10a)

9b. IF YES: Please indicate the material’s format. Please check all that apply.

Paper-based:

• Pamphlet

• Handout

• Question & Answer sheet

• Brochure

• Booklet

Multimedia:

• CD

• DVD

• Video

• Website (to refer to for additional materials)

Other, specify:______________________

9c. Is the material supplied by your facility or by the manufacturer?

___ Facility

___ Manufacturer

___ Both

___ Other, specify: _____________________

10a. Are patients monitored when using these devices in the home setting?

YES (Go to Q10b)

NO (Go to Q11a)

DON’T KNOW (GO TO Q11a)

10b. Who monitors these patients? Please check all that apply.

___ Registered nurse (i.e., home care nurse)

___ LPN

___ Aide (includes CNAs, techs, etc.)

___ Other ___________

10c. How often are visits scheduled to check on the patient?’

___ times per week

___ times per month

___ Other, specify: ___________________

• Training and Labeling

11a. Do patients and their caregivers receive training on the NPWT system?

YES (Go to Q11b)

NO (Go to Q12a)

11b. Is training mandatory for patients and caregivers who use the device in the home?

YES (Go to Q11c)

NO (Go to Q12a)

11c. Who conducts the training?

• Prescribing physician

• Nurse educator

• Registered nurse (i.e., home care nurse)

• LPN

• Aide (CNAs, techs, etc.)

• Wound care nurse

• Other ________

11d. Where does the patient/caregiver training take place?

___ Hospital

___ Home

___ Long-term care facility

___ Other, specify: _________

11e. Please describe the training. Is it: [Please check all that apply.]

___ Video-based

___ Hands-on
___ Demonstration

___ Other, specify _________

12a. Do the NPWT systems have labels or other written instructions?

YES (Go to Q12b)

NO (Go to Q13a)

12b. In your opinion, are the labels or other device instructions written for a lay audience?

YES

NO

13a. Have you observed challenges with caregivers’ ability to understand and follow device instructions?

YES (Go to Q13b)

NO (Go to Q14a)

13b. Which, of the conditions below do you believe may be the reason for this? Please check all that apply.

• Language barriers

• Patient and caregiver distracted (due to illness, altered consciousness, or other medical situation)

• Material difficult to see/read

• Material does not include pictures/diagrams

• Instructions not organized well

• Other challenges, specify:_____________

• Issues associated with gauze or foam dressing

14a. How often are dressings changed?

___ times per day

____times per week

___ Other: ________________

___ Don’t know (Go to Q15a)

14b. What factors does your organization use to determine how often dressings should be changed? Please check all that apply.

• Type of wound

• Stage of wound

• Location of wound

• Patient risk factors and co-morbidities

• Patient characteristics

• Doctor’s orders

• Labeling provided by manufacturer

• Policy developed by your institution

• Other, specify:__________

14c. Who changes the dressing? Please check all that apply.

___ Registered nurse (i.e., home care nurse)

___LPN

___Aide (e.g., CNA, techs)

___Caregiver

___Patient

___Other, specify: ___________

15a. What are the most common reasons or complications you see that warrant dressing removal and change? Please check all that apply.

• Bleeding

• Pain

• Infection

• Odor

• Tissue granulation and in-growth into foam

• Inadequate seal

• Inadequate suction

• Other, specify:_________________

15b. How often do these complications occur?

___ Frequently

___ Occasionally

___ Rarely

___ Never

16a. Are the dressings you use:

___ Pre-cut (Go to Q17)

___ Able to be modified, depending on the wound (Go to Q16b)

___ Both (Go to Q16b)

16b. How often are the dressings modified?

___ Always

___ Frequently

___ Occasionally

___ Rarely

___ Never

___ Don’t know

17. Does your organization use foam or gauze dressing(s)?

___Foam

___Gauze

___Both

___Other, specify:

18. Have patients experienced tissue adherence to the dressing, which may contribute to bleeding events?

YES

NO

19a. Do patients experience any additional complications during dressing changes?

YES (Go to Q19b)

NO (Go to Q20a)

19b. IF YES: Please describe these problems or complications.

TEXT RESPONSE

20a. Have patients experienced any other complications with the dressings?

YES (Go to Q20b)

NO (Go to Q21a)

20b. IF YES: Please describe these complications.

TEXT RESPONSE

• Patient outcome

21a. In your opinion, are patient outcomes dependent upon specific patient characteristics?

YES (Go to Q21b)

NO (Go to Q22a)

21b. Of the following patient characteristics, please select up to three that you feel are the most important ones affecting patient outcomes.

___Type of wound

___ Stage of wound

___ Location of wound

___ Patient age

___ Patient’s capabilities

___ Caregiver support

___ Provider support

___ Other ______________

22a. In general, do you think patients can do this kind of wound care safely at home by themselves?

YES

NO

22b. Please explain:

TEXT RESPONSE

23. What do you think could be done to better inform patients of the risks/benefits associated with using these systems, especially in the home setting?

___Better patient-provider communication

___Better training

___Better materials

___Nothing

___Other, specify:____________

Thank you for your time.

10