Comparison between combination of copper, zinc and sucralfate with white soft paraffin in the treatment of of fissure of nipple in breast feeding female
Fissure of nipples are one of the most common causes of unsuccessfully breast feeding during the first few days after birth. There are many modalities for treatment with different therapeutic effects for sore nipples. The treatment of choice for fissure of nipple is emollient such as White soft paraffin. This is a double-blind randomized clinical trial to compare the effect of Cicalfate cream versus White soft paraffin in the treatment of fissure in Beheshti hospital in Kashan. Breast feeding females with fissure of nipple without underlying disease such as Diabetes Mellitus; Rhumathologic Diseases; Malignancy; Abscess and infection in breast will be rnrolled. One hundred patients are enrolled in two groups (Cicalfate cream, and White soft paraffin, randomly. Cicalfate users will be applied Cicalfate cream twice daily on fissure of nipples for 14 days and white soft Paraffin will be applied as the same way. They will be followed at 7th and 14th days after beginning the treatment to monitor the grading and healing of fissure and side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901283734N1
Registration date:2011-07-26, 1390/05/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-07-26, 1390/05/04
Registrant information
Name
Rezvan Talaee
Name of organization / entity
Kashan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1445 5370
Email address
talaei-re@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor of research, Kashan University of Medical Sciences
Expected recruitment start date
2011-11-01, 1390/08/10
Expected recruitment end date
2013-06-30, 1392/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between combination of copper, zinc and sucralfate with white soft paraffin in the treatment of of fissure of nipple in breast feeding female
Public title
Comparison between combination of copper, zinc and sucralfate with white soft paraffin in the treatment of fissure of nipple in breast feeding female
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :Breast feeding females with fissure of nipple
exclusion criteria : underlying disease such as Diabetes Mellitus; Rhumathologic Diseases; Malignancy; Abscess and infection in breast
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Postal code
8715988141
Approval date
2010-02-24, 1388/12/05
Ethics committee reference number
8852
Health conditions studied
1
Description of health condition studied
fissure of nipple
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
wound healing
Timepoint
7 and 14 days after intervention
Method of measurement
clinical and physical examination
Secondary outcomes
1
Description
side effects
Timepoint
7 and 14 days after intervention
Method of measurement
clinical examination and interview with patients
Intervention groups
1
Description
Intervention: cicalfate cream (composed of copper, zinc and sucralfate) twice daily for 14 days
Category
Treatment - Drugs
2
Description
Control group: white soft paraffin twice daily for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Dr. Rezvan Talaee
Street address
Ghotb Ravandi Bulvard
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanceller of Research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Vice Chanceller of Research, Kashan University of Medical Sciences, 5th Kilometer Ghotbe Ravandi Bulv.
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller of Research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan university of medical sciences
Full name of responsible person
Rezvan Talaee
Position
Dermatologist/ Assistant professor
Other areas of specialty/work
Street address
Beheshti Hospital, 5th kilometer of Ghotb ravandi Bul.
City
Kashan
Postal code
87159/87151
Phone
+98 36 1555 0026
Fax
+98 36 1445 5370
Email
r_talaee2007@yahoo.com
Web page address
http://beheshti.kaums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Rezvan Talaee
Position
Dermatologist
Other areas of specialty/work
Street address
Beheshti Hospital, Ghotb Ravandi Bulvard,
City
Kashan
Postal code
87159/87151
Phone
+98 36 1555 0026
Fax
+98 36 1445 5370
Email
R_talaee2007@yahoo.com
Web page address
http://beheshti.kaums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Kashan university of medical sciences
Full name of responsible person
Rezvan Talaee
Position
Dermatologist/ Assistant professor
Other areas of specialty/work
Street address
5th kilometer of Ghotb ravandi Bul.,
City
Kashan
Postal code
87159/87151
Phone
+98 36 1555 0026
Fax
+98 36 1445 5370
Email
R_Talaee2007@yahoo.com
Web page address
http://beheshti.kaums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)