user assessment of a new pouching system ... - hollister.ca/media/files/dansac/... · richard...

1
User Assessment of a New Pouching System Designed to Improve Discretion and Confidence Introduction: There is considerable evidence that discretion of an ostomy pouching system is an important consideration for the comfort and quality of life of a person with an ostomy. A new pouching system has been developed to address this specific need, and thereby improve their self-confidence and quality of life. The novel design incorporates a reduced headspace, offset starter hole in the barrier, improved filter and improved closure system in drainable version. When engaged, the closure system provides a profile similar to that of the closed pouch. While providing these improvements, it is critical that the basic function of the pouching system not be compromised. The discretion and confidence benefits are addressed in a companion presentation. The assessment of core attributes is reported here. Methods This study was a prospective, unblinded, historically controlled observational study of a one-piece pouch with enrolment targeted to complete with a minimum of 140 subjects (70 evaluating open pouches and 70 evaluating closed pouches). The study received a waiver of review by the NHS REC and was conducted in accordance with basic ethical principles including informed consent and respect for the confidentiality of participants. Each participant satisfied the inclusion and exclusion criteria and provided signed informed consent prior to enrolment. Individual participation was for one week or upon using either 15 closed pouches or 8 open pouches which ever came first. Participants were asked to complete a usage diary for each pouch worn. Conclusion: The new pouches were well accepted with approximately 85% or greater of the wear occasions being rated as being neutral or positive for the attributes such as cutting/application, wear time, security, ease of draining, filter performance and comfort. With the additional benefit of improved discretion, the new pouch should improve self-confidence and quality of life of those with ostomies while continuing to satisfy the core attributes. Footnotes The pouches in this Clinical Study are Dansac NovaLife 1 Closed and Drainable. Acknowledgement St. George’s Hospital, London, UK Caroline Rudoni Heather Dennis Hillingdon Hospital, Uxbridge, UK Pat Black King’s Mills Hospital, Sutton-in-Ashfield, UK Jane Cox Jackie Hatton Helen Burke The Leeds General Infirmary, Leeds, UK Julie Hemmingway Lucy Ackerman The John Radcliffe Hospital, Oxford, UK Jo Pragnell Fran Woodhouse Milton Keynes General Hospital, Milton Keynes, UK Teresa Williams Grainne Williams Karen Pollington Castle Hill Hospital, Hull, UK Jill Marshall Ann Edwards Chris Brown Authors: Heather Dennis, St. George’s Hospital, London, UK. Caroline Rudoni St. George’s Hospital, London, UK. Teresa Williams Milton Keynes General Hospital, Milton Keynes, UK. Patricia Black, Hillingdon Hospital, Uxbridge, UK. Ann Edwards, Castle Hill Hospital, Cottingham, UK. Jane Cox, King’s Mill Hospital, Sutton-in-Ashfield, UK. Helen Burke, King’s Mills Hospital, Sutton in Ashfield, UK. Julie Hemmingway, The Leeds General Infirmary, Leeds, UK. Jo Pragnell, The John Radcliffe Hospital, Oxford, UK. Richard Murahata, Hollister Incorporated, Libertyville, IL USA. Stacy Schroeder, Hollister Incorporated, Libertyville, IL USA. Michael Riemer, Hollister Incorporated, Libertyville, IL USA. Compared to the pouch you normally use, the wear time of this pouch was: Much shorter About the same Much longer Compared to the pouch you normally use, the wear time of this pouch was: Compared to the pouch you normally use, the pancaking with this pouch was: Much less Much more About the same Compared to the pouch you normally use, the ballooning with this pouch was: Compared to the pouch you normally use, the ballooning with this pouch was: Compared to the pouch you normally use, the pancaking with this pouch was: Compared to the filter on the pouch you normally use, the filter on this pouch performed: Much worse About the same Much better Compared to the filter on the pouch you normally use, the filter on this pouch performed: Compared to the pouch you normally use, this pouch was more comfortable: Disagree Agree Compared to the pouch you normally use, this pouch was more comfortable: Compared to the pouch you normally use, this pouch was less noticeable under your clothing: Compared to the pouch you normally use, this pouch was less noticeable under your clothing: Did the flange lift from the skin? Did you experience any leakage whilst wearing this pouch? Did the flange lift from the skin? Did you experience any leakage whilst wearing this pouch? 1 Piece Closed 1 Piece Open % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 Yes No % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 Much less Much more About the same % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 Much shorter About the same Much longer % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 Yes No Much less Much more About the same % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 % 0 10 20 30 40 50 60 70 80 90 100 Yes, other Yes, came completely away from the skin Yes, some lifting from the skin No, did not lift from the skin Yes, other Yes, came completely away from the skin Yes, some lifting from the skin No, did not lift from the skin Disagree Agree Much worse About the same Much better Disagree Agree Much less Much more About the same Disagree Agree

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Page 1: User Assessment of a New Pouching System ... - hollister.ca/media/files/dansac/... · Richard Murahata, Hollister Incorporated, Libertyville, IL USA. Stacy Schroeder, Hollister Incorporated,

User Assessment of a New Pouching System Designed to Improve Discretion and Confidence

Introduction: There is considerable evidence that discretion of an ostomy pouching system is an important consideration for the comfort and quality of life of a person with an ostomy. A new pouching system has been developed to address this specific need, and thereby improve their self-confidence and quality of life. The novel design incorporates a reduced headspace, offset starter hole in the barrier, improved filter and improved closure system in drainable version. When engaged, the closure system provides a profile similar to that of the closed pouch. While providing these improvements, it is critical that the basic function of the pouching system not be compromised. The discretion and confidence benefits are addressed in a companion presentation. The assessment of core attributes is reported here.

MethodsThis study was a prospective, unblinded, historically controlled observational study of a one-piece pouch with enrolment targeted to complete with a minimum of 140 subjects (70 evaluating open pouches and 70 evaluating closed pouches). The study received a waiver of review by the NHS REC and was conducted in accordance with basic ethical principles including informed consent and respect for the confidentiality of participants. Each participant satisfied the inclusion and exclusion criteria and provided signed informed consent prior to enrolment. Individual participation was for one week or upon using either 15 closed pouches or 8 open pouches which ever came first. Participants were asked to complete a usage diary for each pouch worn.

Conclusion: The new pouches were well accepted with approximately 85% or greater of the wear occasions being rated as being neutral or positive for the attributes such as cutting/application, wear time, security, ease of draining, filter performance and comfort. With the additional benefit of improved discretion, the new pouch should improve self-confidence and quality of life of those with ostomies while continuing to satisfy the core attributes.

FootnotesThe pouches in this Clinical Study are Dansac NovaLife 1 Closed and Drainable.

AcknowledgementSt. George’s Hospital, London, UKCaroline RudoniHeather Dennis Hillingdon Hospital, Uxbridge, UKPat Black King’s Mills Hospital, Sutton-in-Ashfield, UKJane CoxJackie HattonHelen Burke The Leeds General Infirmary, Leeds, UKJulie HemmingwayLucy Ackerman The John Radcliffe Hospital, Oxford, UKJo PragnellFran Woodhouse Milton Keynes General Hospital, Milton Keynes, UKTeresa WilliamsGrainne WilliamsKaren Pollington Castle Hill Hospital, Hull, UKJill MarshallAnn EdwardsChris Brown

Authors: Heather Dennis, St. George’s Hospital, London, UK. Caroline Rudoni St. George’s Hospital, London, UK. Teresa Williams Milton Keynes General Hospital, Milton Keynes, UK. Patricia Black, Hillingdon Hospital, Uxbridge, UK. Ann Edwards, Castle Hill Hospital, Cottingham, UK. Jane Cox, King’s Mill Hospital, Sutton-in-Ashfield, UK. Helen Burke, King’s Mills Hospital, Sutton in Ashfield, UK. Julie Hemmingway, The Leeds General Infirmary, Leeds, UK. Jo Pragnell, The John Radcliffe Hospital, Oxford, UK. Richard Murahata, Hollister Incorporated, Libertyville, IL USA. Stacy Schroeder, Hollister Incorporated, Libertyville, IL USA. Michael Riemer, Hollister Incorporated, Libertyville, IL USA.

Compared to the pouch you normally use, the wear time of this pouch was:

Much sho

rter

About th

e sam

e

Much lon

ger

Compared to the pouch you normally use, the wear time of this pouch was:

Compared to the pouch you normally use, the pancaking with this pouch was:

Much les

s

Much more

About th

e sam

e

Compared to the pouch you normally use, the ballooning with this pouch was:

Compared to the pouch you normally use, the ballooning with this pouch was:

Compared to the pouch you normally use, the pancaking with this pouch was:

Compared to the filter on the pouch you normally use, the filter on this pouch performed:

Much wors

e

About th

e sam

e

Much be

tter

Compared to the filter on the pouch you normally use, the filter on this pouch performed:

Compared to the pouch you normally use, this pouch was more comfortable:

Disagre

eAgre

e

Compared to the pouch you normally use, this pouch was more comfortable:

Compared to the pouch you normally use, this pouch was less noticeable under your clothing:

Compared to the pouch you normally use, this pouch was less noticeable under your clothing:

Did the flange lift from the skin? Did you experience any leakage whilst wearing this pouch?

Did the flange lift from the skin? Did you experience any leakage whilst wearing this pouch?

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Yes, so

me liftin

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Much wors

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Disagre

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