Clinical trial NCT01526967: Observational Evaluation of the Peristomal Skin Condition in Ostomates
Official title: Observational Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™ Skin Barriers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ostomy
Keywords: ostomy
peristomal skin breakdown
ConvaTec Moldable Skin Barriers
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colostomates, ileostomates, urostomates in acute care settings or community at large.

Brief summary: The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.


Eligibility criteria: Inclusion Criteria:

* Subjects who are 18 years old and older.
* Subjects who agree to participate in the evaluation and who have signed the informed consent form.
* Subjects presenting with a stoma (ileostomy, colostomy or urostomy).
* Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier per package insert is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin.

OR

* Subjects presenting with peristomal skin lesions using a traditional barrier and for whom a decision to replace the traditional barrier with ConvaTec Moldable Technology™ Skin Barrier per package insert is made in the context of routine clinical care.

Exclusion Criteria:

* Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem.
* Subjects who are in a simultaneous clinical evaluation.

Primary outcomes:
measure: Peristomal skin condition
timeFrame: At day 12
Secondary outcomes:
measure: Peristomal skin condition
timeFrame: at 1 month
measure: Level of satisfaction
timeFrame: At 2 months
measure: Accessory usage
timeFrame: Up to 2 months
measure: Peristomal Skin Condition
timeFrame: At 2 months
measure: Level of satisfaction
timeFrame: At 12 days
measure: Level of satisfaction
timeFrame: At 1 month
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Independent Nurse Consultant
state: Arizona
city: Concord
country: United States
facility: John Muir Health Concord Campus
state: California
city: Plymoth
country: United States
facility: Conn. Clinical Nursing Associate, LLC
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Home Health
state: Florida
city: Valparaiso
country: United States
facility: Porter Hospital
state: Indiana
city: Cambridge
country: United States
facility: Serena Group - Dr. Thomas Serena MD
state: Massachusetts
city: Clinton Township
country: United States
facility: Henry Ford Macomb Hospital
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: St. Louis
country: United States
facility: St. Anthony's Medical Center
state: Missouri
city: Columbus
country: United States
facility: ID Med Inc.
state: Ohio
city: Pawtucket
country: United States
facility: RI Colorectal Clinic, LLC
state: Rhode Island
city: Baytown
country: United States
facility: San Jacinto Methodist Hospital
state: Texas
city: Renton
country: United States
facility: NW Pavillion Ostomy Clinic
state: Washington
Study officials:
affiliation: ConvaTec Inc.
name: Qing Li, Ph.D, MD
role: STUDY_CHAIR
References: