PMID- 27500487
OWN - NLM
STAT- MEDLINE
DCOM- 20171113
LR  - 20171113
IS  - 1600-0846 (Electronic)
IS  - 0909-752X (Linking)
VI  - 23
IP  - 2
DP  - 2017 May
TI  - A randomized, controlled trial comparing skin health effects and comfort of two 
      adult incontinence protective underwear.
PG  - 202-211
LID - 10.1111/srt.12320 [doi]
AB  - BACKGROUND/PURPOSE: It is important to confirm product use effects on skin health 
      for products intended for prolonged skin contact. This study compared 
      experimental and marketed reference adult incontinence protective underwear. 
      METHODS: Randomized, single-blind (examiner), parallel study evaluating skin 
      health effects in predominantly obese incontinent women normally using protective 
      underwear (approximately 20% Type II Diabetes). Subjects wore experimental or 
      marketed reference protective underwear daily, 14 consecutive days. Visual skin 
      grading, transepidermal water loss (TEWL) assessed before, after 1 and 2 weeks of 
      product wear. Overall assessment of comfort assessed. RESULTS: Of the 122 
      subjects (60 experimental and 62 marketed reference), 22 were diabetic and 88 
      were postmenopausal. Under the conditions of this study, there were no 
      statistically significant differences in overall change from baseline for visual 
      grading and TEWL between the experimental product and the marketed reference 
      product for all subjects. Changes from baseline for skin erythema and skin 
      marking were generally small for both products for all subjects as well as for 
      both diabetics and non-diabetics. There were no serious adverse events (AEs), and 
      no withdrawals due to AEs. Overall comfort assessments of size and fit were 'just 
      right,' and skin comfort in the leg, waist and crotch areas were 'comfortable' or 
      'very comfortable' for both products. CONCLUSIONS: In-use 14-day testing 
      demonstrated few statistical differences between experimental product with unique 
      odor neutralizing technology and currently marketed product for skin assessments 
      and comfort. Both products were comfortable and well-tolerated.
CI  - (c) 2016 The Authors. Skin Research and Technology published by John Wiley & Sons 
      Ltd.
FAU - Trowbridge, M M
AU  - Trowbridge MM
AD  - Department of Global Clinical Sciences, The Procter & Gamble Co, Cincinnati, OH, 
      USA.
FAU - Wang, B
AU  - Wang B
AD  - Department of Quantitative Sciences, The Procter & Gamble Co, Cincinnati, OH, 
      USA.
FAU - Gutshall, D
AU  - Gutshall D
AD  - Department of Central Product Safety, The Procter & Gamble Co, Cincinnati, OH, 
      USA.
FAU - Rodenberg, C A
AU  - Rodenberg CA
AD  - Department of Quantitative Sciences, The Procter & Gamble Co, Cincinnati, OH, 
      USA.
FAU - Farage, M A
AU  - Farage MA
AD  - Department of Global Clinical Sciences, The Procter & Gamble Co, Cincinnati, OH, 
      USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160808
PL  - England
TA  - Skin Res Technol
JT  - Skin research and technology : official journal of International Society for 
      Bioengineering and the Skin (ISBS) [and] International Society for Digital 
      Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI)
JID - 9504453
SB  - IM
MH  - Causality
MH  - Comorbidity
MH  - Dermatitis, Contact/*epidemiology/prevention & control
MH  - Equipment Design
MH  - Equipment Failure Analysis
MH  - Female
MH  - Humans
MH  - Incontinence Pads/*statistics & numerical data
MH  - Male
MH  - Middle Aged
MH  - Patient Comfort
MH  - Patient Satisfaction/*statistics & numerical data
MH  - Prevalence
MH  - Protective Clothing/*statistics & numerical data
MH  - Risk Factors
MH  - Single-Blind Method
MH  - Treatment Outcome
MH  - Urinary Incontinence/*epidemiology/*nursing
OTO - NOTNLM
OT  - diabetes
OT  - erythema
OT  - female incontinence
OT  - protective underwear
OT  - skin health
OT  - transepidermal water loss
EDAT- 2016/08/09 06:00
MHDA- 2017/11/14 06:00
CRDT- 2016/08/09 06:00
PHST- 2016/06/21 00:00 [accepted]
PHST- 2016/08/09 06:00 [pubmed]
PHST- 2017/11/14 06:00 [medline]
PHST- 2016/08/09 06:00 [entrez]
AID - 10.1111/srt.12320 [doi]
PST - ppublish
SO  - Skin Res Technol. 2017 May;23(2):202-211. doi: 10.1111/srt.12320. Epub 2016 Aug 
      8.