Determination of clinical and laboratory results obtained from the use of two different wraps in reducing the number and size of polyps in patients with bladder exstrophy using these plastic wraps
Objective: The aim of this study was to assess the role of high-barrier plastic wraps in reducing polyps’ size and number, as well as decreasing the inflammation and allergic reactions in bladder exstrophy cases.
Design: Eight patients with bladder exstrophy-epispadias complex (BEEC) that used a low density polyethylene (LDPE) for coverage of the exposed polypoid bladder in preoperative care management were referred to our center. These patients used a high-barrier wrap made of polyvinylidene chloride (PVdC) until the time of closure. The new wrap was applied for an average duration of 1 year before surgery. Polyp size and number, incidence of para-exstrophy skin infection/inflammation, and skin allergy were assessed every 2 months. Biopsies were taken from the polyps to identify histopathological characteristics of the exposed polyps. The characteristics of the wraps were also evaluated by Fourier transform infrared spectroscopy (FTIS), scanning electron microscopy (SEM), evaporation tests, and bacterial culture tests.
Results: Polyps’ size and number decreased in patients after the application of a high-barrier wrap after 12 months. There was no allergic reaction in patients after the usage of PVdC. Moreover, none of the patients developed pre-malignant changes in histopathological examinations after 12 months. PVdC had higher integrity and smaller pores in SEM. Evaporation and penetration tests were also more satisfactory in PVdC
Conclusion: Polyps’ size, number, and morbidity may significantly decrease by applying a high-barrier wrap. Certain PVdC wraps (Saran wraps) with more integrity and less evaporative permeability may be more “exstrophy-friendly.”
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611268554N2
Registration date:2017-04-23, 1396/02/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-23, 1396/02/03
Registrant information
Name
Abdol-mohammad Kajbafzadeh
Name of organization / entity
pediatric urology and reconstructive medicine research center
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 5400
Email address
kajbafzd@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-11-06, 1395/08/16
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of clinical and laboratory results obtained from the use of two different wraps in reducing the number and size of polyps in patients with bladder exstrophy using these plastic wraps
Public title
The use of two different wraps in reducing the number and size of polyps in patients with bladder exstrophy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Children with bladder exstrophy and simultaneous bladder polyps; children in whom LDPE wrap with low permeability was applied before entering the study; children with obtained informed consent from parents in pediatric urology research center
Exclusion criteria: Children with bladder exstrophy and simultaneous bladder polyps who use PVDC wrap before entering the study; children in whom informed consent was not obtained from parents
Age
From 1 day old to 13 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
: No. 62, Dr. Qarib’s Street, Keshavarz Boulevard
City
Tehran
Postal code
1419433151
Approval date
2016-05-18, 1395/02/29
Ethics committee reference number
IR.TUMS.REC.1395.2614
Health conditions studied
1
Description of health condition studied
Bladder exstrophy
ICD-10 code
Q64.1
ICD-10 code description
Exstrophy of urinary bladder
Primary outcomes
1
Description
Number of polyps
Timepoint
During the study
Method of measurement
Counting
2
Description
Size of polyps
Timepoint
During the study
Method of measurement
Measure with ruler
Secondary outcomes
1
Description
Number of polyps
Timepoint
In the end of study
Method of measurement
Counting
2
Description
Size of polyps
Timepoint
In the end of study
Method of measurement
Measure with ruler
Intervention groups
1
Description
At birth, the sensitive exposed bladder mucosa should be covered with a non-adherent film (Plastic Wrap) (PVDC) to prevent infection and sticking of the bladder to diapers or clothing.
Category
Treatment - Other
2
Description
At birth, the sensitive exposed bladder mucosa should be covered with a non-adherent film (Plastic Wrap) (LDPE) to prevent infection and sticking of the bladder to diapers or clothing.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Hospital Medical Center
Full name of responsible person
Street address
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Miss Norouzzadeh
Street address
Floor 6. Ghods Street, Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammadjavad Mohseni
Position
MD, Manager Pediatric Urology And Regenerative Medicine Research Centre
Other areas of specialty/work
Street address
Children's Medical Center, Qarib St, Keshavarz Blvd, Tehran 14194, Iran