<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02991833</url>
  </required_header>
  <id_info>
    <org_study_id>EGE.0.20.05.00/BOY/1718/99Z</org_study_id>
    <nct_id>NCT02991833</nct_id>
  </id_info>
  <brief_title>Developing Of A New Incontinence Care Product</brief_title>
  <official_title>&quot;Developing Of A New Incontinence Care Product, And Investigation Of The Effect Of Its On Perineal Dermatitis in Woman Patients Fecal Incontinence&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomized controlled clinical trial, prospective study is to developing a&#xD;
      new incontinece care product for containing the fecal incontinence and to examine the effect&#xD;
      of this new product on prevention of perineal dermatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary and faecal incontinence which affected the large number of people are common and&#xD;
      embarrassing health problems. Urinary incontinence affects the life quality , and causes to&#xD;
      isolation and depression. Faecal incontinence can cause to psychosocial problems such as loss&#xD;
      of self-esteem, progressive isolation, social stigmatisation and reduces the life quality,&#xD;
      also burden a high cost on the patients and the community . Both urinary and fecal&#xD;
      incontinence may leads to incontinence-associated dermatitis (IAD), an inflamatory skin&#xD;
      disease, which is a a clinical evolution of skin damage associated with moisture , as a&#xD;
      result of chronic or repeated exposure of the skin to urine or fecal matter. In IAD shows as&#xD;
      redness with or without blistering, erosion, or loss of the skin barrier function IAD which&#xD;
      causes discomfort and stres for patients , is a serious and common problem in many health&#xD;
      care setting and impacts patients' well-being. Health care professionals who are working in&#xD;
      many health institutions struggled to giving the optimal care to keep incontinent patients'&#xD;
      skin in a healthy condition. When IAD developed, the risk of infection, the length of&#xD;
      hospitalization, and morbidity increases and those patients are at greater risk of developing&#xD;
      a pressure ulser.&#xD;
&#xD;
      The research question was; are there differences in the incidence of IAD in patients with&#xD;
      fecal incontinence by a new incontinece care versus adult diaper.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A New Incontinence Care Product associated dermatitis</measure>
    <time_frame>3 months</time_frame>
    <description>Women patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product (diaper and the novel incontinent care product) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.We defined IAD having an erithema score of 1 or more, in the skin of buttock, sacrum, thight and groin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diaper associated dermatitis</measure>
    <time_frame>3 months</time_frame>
    <description>Women patients were observed and evaluated daily during the morning care&#xD;
between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product (diaper and the novel incontinent care product) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.We defined IAD having an erithema score of 1 or more, in the skin of buttock, sacrum, thight and groin.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Incontinence-associated Dermatitis</condition>
  <condition>Nursing Care</condition>
  <arm_group>
    <arm_group_label>Of A New Incontinence Care Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product ( the novel incontinent care product) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diaper</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product (diaper ) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A New Incontinence Care Product</intervention_name>
    <description>The novel incontinent care product is dressed and removed removed by opening both sides. In the part surrounding the waist and thights of the novel incontinent care product flexibility is achieved by planting rubber bien. When developing new incontinence care products was taken counselling from a faculty member from Department of Textile Engineering of one University Faculty of Engineering. The insurance policies was prepared for each patients attended to the study (Number: 481360).New care product is put on the experimental group. Perineal care was made to patients twice a day and after each defecation. After each perineal care, the novel incontinent care product was changed.</description>
    <arm_group_label>Of A New Incontinence Care Product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diaper</intervention_name>
    <description>In patients of the diaper group was used the optimum adult diaper (Pads, Linea TENA, SCA, Hygiene, Goteborg, Sweden) which was available in the market. Perineal care was made to patients twice a day and after each defecation. After each perineal care, the diaper was changed.</description>
    <arm_group_label>Diaper</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  bedridden patients who had fecal and urinary incontinence,&#xD;
&#xD;
          -  had not diabetes mellitus,&#xD;
&#xD;
          -  patients whose perineal and perianal skin is intact,&#xD;
&#xD;
          -  had indwelling urethral catheter and&#xD;
&#xD;
          -  patient who accepted to participate to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who had diabetes mellitus,&#xD;
&#xD;
          -  patients whose had darkly pigmented area in the perineal and perianal area,&#xD;
&#xD;
          -  patients had pressure ulcers or erithema&#xD;
&#xD;
          -  who have not accepted to participate&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LEYLA KHORSHID, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Ege University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ege University</name>
      <address>
        <city>Izmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>October 27, 2017</last_update_submitted>
  <last_update_submitted_qc>October 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Leyla Khorshitd</investigator_full_name>
    <investigator_title>PROFESSOR DR.</investigator_title>
  </responsible_party>
  <keyword>fecal incontinence</keyword>
  <keyword>care product</keyword>
  <keyword>bowel incontinence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 daysThe visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased.</ipd_description>
    <ipd_time_frame>3 months</ipd_time_frame>
    <ipd_access_criteria>perineal dermatitis, fecal incontinence</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02991833
org study id: EGE.0.20.05.00/BOY/1718/99Z
nct id: NCT02991833
lead sponsor: 
has dmc: No
The aim of this randomized controlled clinical trial, prospective study is to developing a
      new incontinece care product for containing the fecal incontinence and to examine the effect
      of this new product on prevention of perineal dermatitis.
Urinary and faecal incontinence which affected the large number of people are common and
      embarrassing health problems. Urinary incontinence affects the life quality , and causes to
      isolation and depression. Faecal incontinence can cause to psychosocial problems such as loss
      of self-esteem, progressive isolation, social stigmatisation and reduces the life quality,
      also burden a high cost on the patients and the community . Both urinary and fecal
      incontinence may leads to incontinence-associated dermatitis (IAD), an inflamatory skin
      disease, which is a a clinical evolution of skin damage associated with moisture , as a
      result of chronic or repeated exposure of the skin to urine or fecal matter. In IAD shows as
      redness with or without blistering, erosion, or loss of the skin barrier function IAD which
      causes discomfort and stres for patients , is a serious and common problem in many health
      care setting and impacts patients' well-being. Health care professionals who are working in
      many health institutions struggled to giving the optimal care to keep incontinent patients'
      skin in a healthy condition. When IAD developed, the risk of infection, the length of
      hospitalization, and morbidity increases and those patients are at greater risk of developing
      a pressure ulser.

      The research question was; are there differences in the incidence of IAD in patients with
      fecal incontinence by a new incontinece care versus adult diaper.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: A New Incontinence Care Product associated dermatitis
time frame: 3 months
description: Women patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product (diaper and the novel incontinent care product) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.We defined IAD having an erithema score of 1 or more, in the skin of buttock, sacrum, thight and groin.
measure: Diaper associated dermatitis
time frame: 3 months
description: Women patients were observed and evaluated daily during the morning care
between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product (diaper and the novel incontinent care product) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.We defined IAD having an erithema score of 1 or more, in the skin of buttock, sacrum, thight and groin.
arm group label: Of A New Incontinence Care Product
arm group type: Experimental
description: Patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product ( the novel incontinent care product) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.
arm group label: Diaper
arm group type: Active Comparator
description: Patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product (diaper ) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.
intervention type: Other
intervention name: A New Incontinence Care Product
description: The novel incontinent care product is dressed and removed removed by opening both sides. In the part surrounding the waist and thights of the novel incontinent care product flexibility is achieved by planting rubber bien. When developing new incontinence care products was taken counselling from a faculty member from Department of Textile Engineering of one University Faculty of Engineering. The insurance policies was prepared for each patients attended to the study (Number: 481360).New care product is put on the experimental group. Perineal care was made to patients twice a day and after each defecation. After each perineal care, the novel incontinent care product was changed.
arm group label: Of A New Incontinence Care Product
intervention type: Other
intervention name: Diaper
description: In patients of the diaper group was used the optimum adult diaper (Pads, Linea TENA, SCA, Hygiene, Goteborg, Sweden) which was available in the market. Perineal care was made to patients twice a day and after each defecation. After each perineal care, the diaper was changed.
arm group label: Diaper
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: LEYLA KHORSHID, Professor
role: Study Director
affiliation: Ege University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Leyla Khorshitd
investigator title: PROFESSOR DR.
mesh term: Fecal Incontinence
mesh term: Dermatitis
sharing ipd: Yes
ipd description: Patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 daysThe visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased.
ipd time frame: 3 months
ipd access criteria: perineal dermatitis, fecal incontinence