Mandibular reconstruction plates have revolutionized the treatment of mandibular continuity defects following ablative or trauma surgery. Plate exposure is one of the most serious complications in mandibular reconstruction field. Plate exposure is closely associated with patients who received radiation therapy, and have lateral defects reconstructed with a plate only or plate/flap reconstruction.Our hypothesis was based on adding a synthetic barrier between soft tissue and reconstruction plate.This kind of isolation is routine in reconstructive field of orthopedic surgery with synthetic barrier that have been called ”attachment tube. This polyethylenterephtalat(PET)tube(MUTARS®, Implant cast GmbH) allows for reconstruction of the capsule and refixation of the muscles and helps minimize dislocation when it is used in proximal treatments of the homeruns(rotator cuff) and femur. Patients between 20 and 70 with partial mandibulectomy due to malignant tumor, underwent reconstruction with RP and membrane or reconstruction plate and membranre and free vascular flap. These patients will have at least 30 session radiotherapy after surgical procedure.These patients will have 2 years follow up for evaluating plate exposure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211065496N2
Registration date:2012-12-05, 1391/09/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-05, 1391/09/15
Registrant information
Name
Ata Garajei
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 0673
Email address
atagarajei@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences,Vice- Chancellor for Research,
Craniomaxillofacial Research Center
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of using synthetic membrane for plates of reconstructing mandible on frequency of exposure
Public title
Evaluation of effect of using synthetic barrier for plates of reconstructing mandible on frequency of exposure
Purpose
Treatment
Inclusion/Exclusion criteria
Patients between 20 and 70 with partial mandibulectomy due to malignant tumor, underwent reconstruction with reconstruction plate and membrane or reconstruction plate and membranre and free vascular flap. These patients will have at least 30 session radiotherapy after surgical procedure.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2012-11-10, 1391/08/20
Ethics committee reference number
90-04-106-16129-69824
Health conditions studied
1
Description of health condition studied
Mandibular Reconstruction
ICD-10 code
Z42.0
ICD-10 code description
Follow-up care involving plastic surgery of head and neck
Primary outcomes
1
Description
Plate Exposure
Timepoint
Three monthly
Method of measurement
Observation by one fix observer
Secondary outcomes
1
Description
Infection
Timepoint
Monthly
Method of measurement
Observation of pus and other sistemic sign and symptom
2
Description
Recurrence of primary tumor
Timepoint
Monthly
Method of measurement
Observation any sign presentig recurrence
Intervention groups
1
Description
adding a synthetic barrier between soft tissue and reconstruction plate.This kind of isolation is routine in reconstructive field of orthopedic surgery with synthetic barrier that have been called ”attachment tube".
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute
Full name of responsible person
Ata Garajei
Street address
Imam Hospital complex-Opratin Room of cancer Institute
City
Tehran
2
Recruitment center
Name of recruitment center
Shariati Hospital, Department of Oral and Maxillofacial Surgery
Full name of responsible person
Ata Garajei
Street address
Shariati Hospital, Department of Oral and Maxillofacial Surgery
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Craniomaxillofacial Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Bayat
Street address
Shariati Hospita, Department of Oral and Maxillofacial surgery
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Craniomaxillofacial Research Center, 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
Craniomaxillofacial Reserch Center
Full name of responsible person
Dr armita Arvin
Position
Dentist
Other areas of specialty/work
Street address
Shariati Hospital, department of Oral and maxillofacial Surgery
City
Tehran
Postal code
Phone
+98 21 8490 2464
Fax
Email
armita85@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Ata Garajei
Position
Board Certified
Other areas of specialty/work
Street address
Imam hospital complex-Oprating room of Cancer Institute
City
Tehran
Postal code
Phone
+98 21 6658 1544
Fax
+98 21 6658 1526
Email
atagarajei@tums.ac.iratagarajei@gmail.com
Web page address
http://www.tums.ac.ir/faculties/atagarajei
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Ata Garajei
Position
Board Certified
Other areas of specialty/work
Street address
Imam hospital complex-Oprating room of Cancer Institute
City
Tehran
Postal code
Iran
Phone
+98 21 6658 1544
Fax
+98 21 6658 1526
Email
atagarajei@tums.ac.ir atagarajei@gmail.com
Web page address
http://www.tums.ac.ir/faculties/atagarajei
Sharing plan
Deidentified Individual Participant Data Set (IPD)