Contact information
Type
Scientific
Primary contact
Dr George Piendo
ORCID ID
Contact details
Marcoleta 367
Santiago
-
Chile
gpinedom@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Zinc-aluminium ointment for patients with faecal incontinence: a double blind randomised trial
Acronym
ZAOT
Study hypothesis
The use of Zinc-aluminium (Zn-Al) ointment improve the continence in patients with faecal incontinence.
Ethics approval
Medical Ethics Committee of the Pontificia Universidad Catolica de Chile approved on the 1st April 2008 (ref: 109/08)
Study design
Double blind randomised placebo controlled phase II trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Faecal incontinence
Intervention
Treatment group:
Topical application of ointment in the perianal region for 4 weeks. Ointment consists of
Aluminum Sulphate (0.5%), Zinc Sulphate (0.1%), Benzocaine (0.05%), Clorhexidine (0.09%) and Titanium Dioxide (0.1%)
Placebo group:
Topical application of Novobase II in the perianal region for 4 weeks.
Intervention type
Drug
Phase
Not Applicable
Drug names
Zinc-aluminium ointment
Primary outcome measures
Wexner Score, measured at baseline and 4 weeks
Secondary outcome measures
Faecal Incontinence Quality of Life (FIQL) score, measured at baseline and 4 weeks
Overall trial start date
10/03/2010
Overall trial end date
24/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Female
2. Aged 18 years or older
3. Consulted the outpatient clinic in the Colorectal unit of Pontificia Universidad Catolica de Chile
4. Faecal incontinence
5. Wexner Score greater than or equal to 7
6. Minima sphincter disruption in anal endosonography
7. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50 patients
Participant exclusion criteria
1. Male
2. Sphincter disruption greater than 50%
Recruitment start date
10/03/2010
Recruitment end date
24/04/2010
Locations
Countries of recruitment
Chile
Trial participating centre
Marcoleta 367
Santiago
-
Chile
Sponsor information
Organisation
Pontifical Catholic University of Chile (Pontificia Universidad Católica de Chile) (Chile)
Sponsor details
c/o Dr George Pinedo
Marcoleta 367
Santiago
-
Chile
gpinedom@hotmail.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Pontifical Catholic University of Chile (Pontificia Universidad Católica de Chile) (Chile) - Surgical Department
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary