Zinc-aluminium ointment for patients with faecal incontinence
| ISRCTN | ISRCTN05200282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05200282 |
| Protocol serial number | N/A |
| Sponsor | Pontifical Catholic University of Chile (Pontificia Universidad Católica de Chile) (Chile) |
| Funder | Pontifical Catholic University of Chile (Pontificia Universidad Católica de Chile) (Chile) - Surgical Department |
- Submission date
- 05/11/2010
- Registration date
- 08/12/2010
- Last edited
- 08/12/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr George Piendo
Scientific
Scientific
Marcoleta 367
Santiago
-
Chile
| gpinedom@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomised placebo controlled phase II trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Zinc-aluminium ointment for patients with faecal incontinence: a double blind randomised trial |
| Study acronym | ZAOT |
| Study objectives | The use of Zinc-aluminium (Zn-Al) ointment improve the continence in patients with faecal incontinence. |
| Ethics approval(s) | Medical Ethics Committee of the Pontificia Universidad Catolica de Chile approved on the 1st April 2008 (ref: 109/08) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Zinc-aluminium ointment |
| Primary outcome measure(s) |
Wexner Score, measured at baseline and 4 weeks |
| Key secondary outcome measure(s) |
Faecal Incontinence Quality of Life (FIQL) score, measured at baseline and 4 weeks |
| Completion date | 24/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 50 |
| Key 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 |
| Key exclusion criteria | 1. Male 2. Sphincter disruption greater than 50% |
| Date of first enrolment | 10/03/2010 |
| Date of final enrolment | 24/04/2010 |
Locations
Countries of recruitment
- Chile
Study participating centre
Marcoleta 367
Santiago
-
Chile
-
Chile
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
