<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03280849</url>
  </required_header>
  <id_info>
    <org_study_id>CI.064.2015</org_study_id>
    <nct_id>NCT03280849</nct_id>
  </id_info>
  <brief_title>Chitosan Scaffold for Sellar Floor Repair in Endoscopic Endonasal Transsphenoidal Surgery</brief_title>
  <official_title>Chitosan Scaffold for Sellar Floor Repair in Endoscopic Endonasal Transsphenoidal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Guadalajara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Guadalajara</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 65 year old female participant , right handed, started with progressive bilateral visual&#xD;
      loss in her temporal field, over 10 months, the participant underwent an MRI and it was found&#xD;
      a sellar lesion that compressed the optic chiasm, an endoscopic endonasal transsphenoidal&#xD;
      surgery was done for the resection of the lesion, using a novel bilaminar chitosan scaffold&#xD;
      to assist the closure of the sellar floor. After a follow up of 2 years the participant&#xD;
      returned to its normal visual function, without evidence of the sellar lesion on the&#xD;
      postoperative MRI, and without complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction This case describe the use of a novel bilaminar chitosan scaffold in the repair&#xD;
      of the sellar floor after an endoscopic endonasal transsphenoidal surgery for a suspected&#xD;
      hipofisary macroadenoma, the use of chitosan as a scaffold has been described in several&#xD;
      preclinical studies and tested in tissue bioengineering of bone, neural tissue and soft&#xD;
      tissue, in the case of bone tissue, several studies demonstrated its potential due to its&#xD;
      biocompatibility, osteinductive and osteoconductive features, but there is a lack of clinical&#xD;
      trials demonstrating this characteristics in the clinical setting. One of the most common&#xD;
      complications for the neurosurgeons after an endoscopic endonasal transsphenoidal surgery is&#xD;
      the CSF leak, depending on the technique and the reconstruction used for the sellar floor&#xD;
      this complication could be presented from 5% to 75%of the cases, leading to complications&#xD;
      such infections and pneumoencephalus, representing a great risk for comorbidities, longer&#xD;
      recovery times and hospital costs, due to this challenges in the repair of the sellar&#xD;
      floor,the investigators intent to approach the problematic with a chitosan scaffold for its&#xD;
      characteristics in bone regeneration. The setting of a bioactive membrane in the defect of&#xD;
      the surgery could be useful for a stronger and more suitable closure of the sellar floor.&#xD;
&#xD;
      Case description A 65 years old female participant, right handed, came to the neurosurgery&#xD;
      consultation with progressive bilateral visual loss in her temporal fields, with predominance&#xD;
      in the left eye over 10 months, two weeks before her admission the participant reported a&#xD;
      sudden loss of consciousness, prompting her to go to the hospital. In her clinical&#xD;
      examination, the participant was alert and oriented x3, normal cranial nerves examination&#xD;
      except for decrease visual acuity by 20/200 in her left eye, 20/80 in her right eye,&#xD;
      bitemporal hemianopia and mild primary athropy of the optic disc in the left eye, the gait&#xD;
      and the motor and sensitive examination was normal. The laboratory studies showed a LH: 0.22&#xD;
      and prolactine: 53.7 .In the contrasted preoperative brain MRI, it was found a sellar lesion,&#xD;
      hypointense in T1 but hyperintense in T2 signal with enhancing of the periphery after the&#xD;
      infusion of gadolinium, the lesion presented extension to the sphenoid sinus, paraselar space&#xD;
      without involvement of the carotids and supraselar with displacement of the optic chiasm. The&#xD;
      participant underwent endoscopic endonasal transsphenoidal surgery for resection of the&#xD;
      sellar lesion, under the direct visualization, the lesion appeared redish and soft with&#xD;
      moderately bleeding, a sample was taken for pathology and the remaining is extracted without&#xD;
      complications, then the scaffold is implanted in the site of the bone defect in the sphenoid&#xD;
      sinus, due to its moldable nature, it was easily set, covering the entire extension of the&#xD;
      defect, a fat graft was set in the sphenoid sinus covering the bilaminar chitosan membrane,&#xD;
      then fibrin sealant was used for hemostatic control and a nasal packing was set in both&#xD;
      nostrils for finalize the procedure. In the postoperative there was not complication and&#xD;
      after a few days the participant was discharged with notable clinical improvement, after one&#xD;
      month of follow up the participant recovered her visual acuity and the participant did not&#xD;
      refer any symptom, the participant underwent a post operative brain MRI, where it is observed&#xD;
      a gross total resection and good closure of the sellar floor, without signs of rejection or&#xD;
      inflammation in the zone with the chitosan scaffold.&#xD;
&#xD;
      Materials and methods for the bilaminar chitosan scaffold The bilaminar implant is constitute&#xD;
      by two types of different structures, one of the membranes presents a flat-smooth structure,&#xD;
      the other membrane has a tridimensional-porous structure, each of the physical-chemical&#xD;
      characteristics given to the membranes, was in function of the biological effect pretended in&#xD;
      the effector tissue.&#xD;
&#xD;
      The two types of membranes, synthetized for the elaboration of the bilaminar implant, were&#xD;
      elaborated with biomedical grade chitosan of medium molecular weight with 75-85% of&#xD;
      deacetylation in powder presentation from the brand Sigma Aldrich®, U.S.A.&#xD;
&#xD;
      In the case of the membrane with flat-smooth structure, it was synthetized from a chitosan&#xD;
      solution at 2%, the dissolution medium was diluted acetic acid (Sigma Aldrich®, U.S.A); In&#xD;
      order to acquired a suitable solubilisation, the mix was set on a magnetic stirrer for 1&#xD;
      hour, posteriorly the solution was brought under the action of a sonicator at 28oc for 2&#xD;
      hours, until the air bubbles formed by the stirrer were completely eliminated.&#xD;
&#xD;
      For the membrane with the tridimensional-porous structure, it was synthetized from a chitosan&#xD;
      solution at 4%, the dissolution medium was diluted acetic acid (Sigma Aldrich®, U.S.A); for a&#xD;
      suitable solubilisation, the mix was set on a magnetic stirrer for 4 hours, afterward the&#xD;
      solution was brought under the action of a sonicator at 28oc for 2 hours, until the air&#xD;
      bubbles formed by the stirrer were completely eliminated.&#xD;
&#xD;
      Once the solutions were elaborated, for the synthesis of the two membranes (the flat-smooth&#xD;
      and the tridimensional-porous) both were set in a constant quantity of ml/cm2 in a Petri&#xD;
      dish, in the case of the flat-smooth membrane, it was brought under a procedure of drying&#xD;
      with 98% of humidity loss and for the tridimensional-porous, a procedure of phase separating&#xD;
      was termical induced.&#xD;
&#xD;
      When both membranes are already elaborated, it is proceed to synthetize the bilaminar&#xD;
      implant, the membranes are combined using a solution of chitosan acetate at 2%, that was&#xD;
      distributed uniformly between both membranes to create a sandwich structure, consecutively&#xD;
      the ensemble was put in a Petri dish and the cover was set inverted in the superior aspect of&#xD;
      petri dish. It was set for drying for 24 hours at room temperature and then it was&#xD;
      precipitated in a solution of sodium hydroxide 1N, following the same indications used for&#xD;
      each membrane separately.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Use of a novel bilaminar chitosan scaffold in the repair of the sellar floor after an endoscopic endonasal transsphenoidal surgery for a suspected hipofisary macroadenoma.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brain MRI with and without contrast</measure>
    <time_frame>1 day preoperative</time_frame>
    <description>Axial-coronal-sagittal MRI in T1,T2 signals-measure of the preoperative tumor size</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain MRI with and without contrast</measure>
    <time_frame>1 day postoperative</time_frame>
    <description>Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor size</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Head CT scan</measure>
    <time_frame>1 month postoperative</time_frame>
    <description>Bone window was used to see the repair of bone defect after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain MRI with and without contrast</measure>
    <time_frame>1 month postoperative</time_frame>
    <description>Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain MRI with and without contrast</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain MRI with and without contrast</measure>
    <time_frame>1 year postoperative</time_frame>
    <description>Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain MRI with and without contrast</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Head CT scan</measure>
    <time_frame>6months postoperative</time_frame>
    <description>Bone window was used to see the repair of bone defect after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Head CT scan</measure>
    <time_frame>1 year postoperative</time_frame>
    <description>Bone window was used to see the repair of bone defect after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Head CT scan</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Bone window was used to see the repair of bone defect after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual field test</measure>
    <time_frame>1 day preoperative, follow up: 1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.</time_frame>
    <description>visual field testing looking for compression of optic chiasm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Snellen test</measure>
    <time_frame>1 day preoperative, follow up: 1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.</time_frame>
    <description>visual acuity testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glasgow scale</measure>
    <time_frame>1 day preoperative, follow up :1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.</time_frame>
    <description>level of consciousness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endocrinological panel</measure>
    <time_frame>1 day preoperative, follow up : 1 day postoperative, 15 days postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative</time_frame>
    <description>evaluation of hipofisary function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood cell count</measure>
    <time_frame>1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative</time_frame>
    <description>For evaluation of any inflammatory reaction or infection before or after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acute phase reactans</measure>
    <time_frame>1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative</time_frame>
    <description>For evaluation of any inflammatory reaction or infection before or after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood electrolytesand</measure>
    <time_frame>1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative</time_frame>
    <description>evaluation of renal function and as requirement for surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver function test</measure>
    <time_frame>1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative</time_frame>
    <description>evaluation of liver function and as requirement for surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>coagulation test</measure>
    <time_frame>1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative</time_frame>
    <description>secondary evaluation of liver function, inflammatory reaction or infection before and after the procedure and as requirement for surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>seric creatinine</measure>
    <time_frame>1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative</time_frame>
    <description>evaluation of renal function and as requirement for surgery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Csf Leakage</condition>
  <arm_group>
    <arm_group_label>Patient with bilaminar chitosan implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 65 year old woman, right handed, started with progressive bilateral visual loss in her temporal field, over 10 months, she underwent an MRI and it was found a sellar lesion that compressed the optic chiasm, an endoscopic endonasal transsphenoidal surgery was done for the resection of the lesion, using a novel bilaminar chitosan scaffold to assist the closure of the sellar floor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Implant of bilaminar chitosan scaffold</intervention_name>
    <description>The patient underwent endoscopic endonasal transsphenoidal surgery for resection of the sellar lesion, under the direct visualization, the lesion appeared redish and soft with moderately bleeding, a sample was taken for pathology and the remaining is extracted without complications, then the scaffold is implanted in the site of the bone defect in the sphenoid sinus, due to its moldable nature, it was easily set, covering the entire extension of the defect, a fat graft was set in the sphenoid sinus covering the bilaminar chitosan membrane, then fibrin sealant was used for hemostatic control and a nasal packing was set in both nostrils for finalize the procedure.</description>
    <arm_group_label>Patient with bilaminar chitosan implant</arm_group_label>
    <other_name>Endoscopic endonasal transphenoidal surgery</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male/female patient candidate for an endoscopic endonasal transphenoidal surgery, who&#xD;
             need repair of the sellar floor as part of the surgical procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes, heart diseases, immunological diseases, infectious diseases, bone diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo Ramos Zuñiga, M.D. PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Guadalajara</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brenda Vega Ruiz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guadalajara</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ivan Segura Duran, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guadalajara</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departamento de neurociencias</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44340</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <link>
    <url>http://www.cucs.udg.mx/instituto-de-neurociencias-traslacionales</url>
    <description>website of our institute of traslational neurosciences</description>
  </link>
  <link>
    <url>http://www.cucs.udg.mx/general/departamento-de-neurociencias</url>
    <description>website of our center</description>
  </link>
  <link>
    <url>http://www.hcg.udg.mx</url>
    <description>website of our hospital facilities</description>
  </link>
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  </results_reference>
  <results_reference>
    <citation>Zhang J, Wang C, Wang J, Qu Y, Liu G. In vivo drug release and antibacterial properties of vancomycin loaded hydroxyapatite/chitosan composite. Drug Deliv. 2012 Jun-Jul;19(5):264-9. doi: 10.3109/10717544.2012.704093.</citation>
    <PMID>22823893</PMID>
  </results_reference>
  <results_reference>
    <citation>Pu XM, Yao QQ, Yang Y, Sun ZZ, Zhang QQ. In vitro degradation of three-dimensional chitosan/apatite composite rods prepared via in situ precipitation. Int J Biol Macromol. 2012 Dec;51(5):868-73. doi: 10.1016/j.ijbiomac.2012.07.008. Epub 2012 Jul 16.</citation>
    <PMID>22800729</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim SB, Kim YJ, Yoon TL, Park SA, Cho IH, Kim EJ, Kim IA, Shin JW. The characteristics of a hydroxyapatite-chitosan-PMMA bone cement. Biomaterials. 2004 Nov;25(26):5715-23. doi: 10.1016/j.biomaterials.2004.01.022.</citation>
    <PMID>15147817</PMID>
  </results_reference>
  <results_reference>
    <citation>Teng SH, Lee EJ, Wang P, Shin DS, Kim HE. Three-layered membranes of collagen/hydroxyapatite and chitosan for guided bone regeneration. J Biomed Mater Res B Appl Biomater. 2008 Oct;87(1):132-8. doi: 10.1002/jbm.b.31082.</citation>
    <PMID>18395825</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Guadalajara</investigator_affiliation>
    <investigator_full_name>Ivan Segura Duran</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>chitosan</keyword>
  <keyword>endoscopic</keyword>
  <keyword>sellar tumor</keyword>
  <keyword>biomaterials</keyword>
  <keyword>transphenoidal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrospinal Fluid Leak</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chitosan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>complete MRI sequences, laboratory studies, visual field tests, complete biomaterial patent registration , clinical reports.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03280849
org study id: CI.064.2015
nct id: NCT03280849
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A 65 year old female participant , right handed, started with progressive bilateral visual
      loss in her temporal field, over 10 months, the participant underwent an MRI and it was found
      a sellar lesion that compressed the optic chiasm, an endoscopic endonasal transsphenoidal
      surgery was done for the resection of the lesion, using a novel bilaminar chitosan scaffold
      to assist the closure of the sellar floor. After a follow up of 2 years the participant
      returned to its normal visual function, without evidence of the sellar lesion on the
      postoperative MRI, and without complications.
Introduction This case describe the use of a novel bilaminar chitosan scaffold in the repair
      of the sellar floor after an endoscopic endonasal transsphenoidal surgery for a suspected
      hipofisary macroadenoma, the use of chitosan as a scaffold has been described in several
      preclinical studies and tested in tissue bioengineering of bone, neural tissue and soft
      tissue, in the case of bone tissue, several studies demonstrated its potential due to its
      biocompatibility, osteinductive and osteoconductive features, but there is a lack of clinical
      trials demonstrating this characteristics in the clinical setting. One of the most common
      complications for the neurosurgeons after an endoscopic endonasal transsphenoidal surgery is
      the CSF leak, depending on the technique and the reconstruction used for the sellar floor
      this complication could be presented from 5% to 75%of the cases, leading to complications
      such infections and pneumoencephalus, representing a great risk for comorbidities, longer
      recovery times and hospital costs, due to this challenges in the repair of the sellar
      floor,the investigators intent to approach the problematic with a chitosan scaffold for its
      characteristics in bone regeneration. The setting of a bioactive membrane in the defect of
      the surgery could be useful for a stronger and more suitable closure of the sellar floor.

      Case description A 65 years old female participant, right handed, came to the neurosurgery
      consultation with progressive bilateral visual loss in her temporal fields, with predominance
      in the left eye over 10 months, two weeks before her admission the participant reported a
      sudden loss of consciousness, prompting her to go to the hospital. In her clinical
      examination, the participant was alert and oriented x3, normal cranial nerves examination
      except for decrease visual acuity by 20/200 in her left eye, 20/80 in her right eye,
      bitemporal hemianopia and mild primary athropy of the optic disc in the left eye, the gait
      and the motor and sensitive examination was normal. The laboratory studies showed a LH: 0.22
      and prolactine: 53.7 .In the contrasted preoperative brain MRI, it was found a sellar lesion,
      hypointense in T1 but hyperintense in T2 signal with enhancing of the periphery after the
      infusion of gadolinium, the lesion presented extension to the sphenoid sinus, paraselar space
      without involvement of the carotids and supraselar with displacement of the optic chiasm. The
      participant underwent endoscopic endonasal transsphenoidal surgery for resection of the
      sellar lesion, under the direct visualization, the lesion appeared redish and soft with
      moderately bleeding, a sample was taken for pathology and the remaining is extracted without
      complications, then the scaffold is implanted in the site of the bone defect in the sphenoid
      sinus, due to its moldable nature, it was easily set, covering the entire extension of the
      defect, a fat graft was set in the sphenoid sinus covering the bilaminar chitosan membrane,
      then fibrin sealant was used for hemostatic control and a nasal packing was set in both
      nostrils for finalize the procedure. In the postoperative there was not complication and
      after a few days the participant was discharged with notable clinical improvement, after one
      month of follow up the participant recovered her visual acuity and the participant did not
      refer any symptom, the participant underwent a post operative brain MRI, where it is observed
      a gross total resection and good closure of the sellar floor, without signs of rejection or
      inflammation in the zone with the chitosan scaffold.

      Materials and methods for the bilaminar chitosan scaffold The bilaminar implant is constitute
      by two types of different structures, one of the membranes presents a flat-smooth structure,
      the other membrane has a tridimensional-porous structure, each of the physical-chemical
      characteristics given to the membranes, was in function of the biological effect pretended in
      the effector tissue.

      The two types of membranes, synthetized for the elaboration of the bilaminar implant, were
      elaborated with biomedical grade chitosan of medium molecular weight with 75-85% of
      deacetylation in powder presentation from the brand Sigma Aldrich®, U.S.A.

      In the case of the membrane with flat-smooth structure, it was synthetized from a chitosan
      solution at 2%, the dissolution medium was diluted acetic acid (Sigma Aldrich®, U.S.A); In
      order to acquired a suitable solubilisation, the mix was set on a magnetic stirrer for 1
      hour, posteriorly the solution was brought under the action of a sonicator at 28oc for 2
      hours, until the air bubbles formed by the stirrer were completely eliminated.

      For the membrane with the tridimensional-porous structure, it was synthetized from a chitosan
      solution at 4%, the dissolution medium was diluted acetic acid (Sigma Aldrich®, U.S.A); for a
      suitable solubilisation, the mix was set on a magnetic stirrer for 4 hours, afterward the
      solution was brought under the action of a sonicator at 28oc for 2 hours, until the air
      bubbles formed by the stirrer were completely eliminated.

      Once the solutions were elaborated, for the synthesis of the two membranes (the flat-smooth
      and the tridimensional-porous) both were set in a constant quantity of ml/cm2 in a Petri
      dish, in the case of the flat-smooth membrane, it was brought under a procedure of drying
      with 98% of humidity loss and for the tridimensional-porous, a procedure of phase separating
      was termical induced.

      When both membranes are already elaborated, it is proceed to synthetize the bilaminar
      implant, the membranes are combined using a solution of chitosan acetate at 2%, that was
      distributed uniformly between both membranes to create a sandwich structure, consecutively
      the ensemble was put in a Petri dish and the cover was set inverted in the superior aspect of
      petri dish. It was set for drying for 24 hours at room temperature and then it was
      precipitated in a solution of sodium hydroxide 1N, following the same indications used for
      each membrane separately.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Use of a novel bilaminar chitosan scaffold in the repair of the sellar floor after an endoscopic endonasal transsphenoidal surgery for a suspected hipofisary macroadenoma.
primary purpose: Treatment
masking: None (Open Label)
measure: Brain MRI with and without contrast
time frame: 1 day preoperative
description: Axial-coronal-sagittal MRI in T1,T2 signals-measure of the preoperative tumor size
measure: Brain MRI with and without contrast
time frame: 1 day postoperative
description: Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor size
measure: Head CT scan
time frame: 1 month postoperative
description: Bone window was used to see the repair of bone defect after surgery
measure: Brain MRI with and without contrast
time frame: 1 month postoperative
description: Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
measure: Brain MRI with and without contrast
time frame: 6 months postoperative
description: Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
measure: Brain MRI with and without contrast
time frame: 1 year postoperative
description: Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
measure: Brain MRI with and without contrast
time frame: 2 years postoperative
description: Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
measure: Head CT scan
time frame: 6months postoperative
description: Bone window was used to see the repair of bone defect after surgery
measure: Head CT scan
time frame: 1 year postoperative
description: Bone window was used to see the repair of bone defect after surgery
measure: Head CT scan
time frame: 2 years postoperative
description: Bone window was used to see the repair of bone defect after surgery
measure: Visual field test
time frame: 1 day preoperative, follow up: 1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
description: visual field testing looking for compression of optic chiasm
measure: Snellen test
time frame: 1 day preoperative, follow up: 1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
description: visual acuity testing
measure: Glasgow scale
time frame: 1 day preoperative, follow up :1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
description: level of consciousness
measure: Endocrinological panel
time frame: 1 day preoperative, follow up : 1 day postoperative, 15 days postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
description: evaluation of hipofisary function
measure: Blood cell count
time frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
description: For evaluation of any inflammatory reaction or infection before or after the procedure
measure: acute phase reactans
time frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
description: For evaluation of any inflammatory reaction or infection before or after the procedure
measure: blood electrolytesand
time frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
description: evaluation of renal function and as requirement for surgery
measure: liver function test
time frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
description: evaluation of liver function and as requirement for surgery
measure: coagulation test
time frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
description: secondary evaluation of liver function, inflammatory reaction or infection before and after the procedure and as requirement for surgery.
measure: seric creatinine
time frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
description: evaluation of renal function and as requirement for surgery
arm group label: Patient with bilaminar chitosan implant
arm group type: Experimental
description: A 65 year old woman, right handed, started with progressive bilateral visual loss in her temporal field, over 10 months, she underwent an MRI and it was found a sellar lesion that compressed the optic chiasm, an endoscopic endonasal transsphenoidal surgery was done for the resection of the lesion, using a novel bilaminar chitosan scaffold to assist the closure of the sellar floor.
intervention type: Other
intervention name: Implant of bilaminar chitosan scaffold
description: The patient underwent endoscopic endonasal transsphenoidal surgery for resection of the sellar lesion, under the direct visualization, the lesion appeared redish and soft with moderately bleeding, a sample was taken for pathology and the remaining is extracted without complications, then the scaffold is implanted in the site of the bone defect in the sphenoid sinus, due to its moldable nature, it was easily set, covering the entire extension of the defect, a fat graft was set in the sphenoid sinus covering the bilaminar chitosan membrane, then fibrin sealant was used for hemostatic control and a nasal packing was set in both nostrils for finalize the procedure.
arm group label: Patient with bilaminar chitosan implant
other name: Endoscopic endonasal transphenoidal surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rodrigo Ramos Zuñiga, M.D. PhD
role: Study Chair
affiliation: University of Guadalajara
last name: Brenda Vega Ruiz, PhD
role: Principal Investigator
affiliation: University of Guadalajara
last name: Ivan Segura Duran, M.D.
role: Principal Investigator
affiliation: University of Guadalajara
facility: 
country: Mexico
url: http://www.cucs.udg.mx/instituto-de-neurociencias-traslacionales
description: website of our institute of traslational neurosciences
url: http://www.cucs.udg.mx/general/departamento-de-neurociencias
description: website of our center
url: http://www.hcg.udg.mx
description: website of our hospital facilities
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citation: Zhang J, Wang C, Wang J, Qu Y, Liu G. In vivo drug release and antibacterial properties of vancomycin loaded hydroxyapatite/chitosan composite. Drug Deliv. 2012 Jun-Jul;19(5):264-9. doi: 10.3109/10717544.2012.704093.
PMID: 22823893
citation: Pu XM, Yao QQ, Yang Y, Sun ZZ, Zhang QQ. In vitro degradation of three-dimensional chitosan/apatite composite rods prepared via in situ precipitation. Int J Biol Macromol. 2012 Dec;51(5):868-73. doi: 10.1016/j.ijbiomac.2012.07.008. Epub 2012 Jul 16.
PMID: 22800729
citation: Kim SB, Kim YJ, Yoon TL, Park SA, Cho IH, Kim EJ, Kim IA, Shin JW. The characteristics of a hydroxyapatite-chitosan-PMMA bone cement. Biomaterials. 2004 Nov;25(26):5715-23. doi: 10.1016/j.biomaterials.2004.01.022.
PMID: 15147817
citation: Teng SH, Lee EJ, Wang P, Shin DS, Kim HE. Three-layered membranes of collagen/hydroxyapatite and chitosan for guided bone regeneration. J Biomed Mater Res B Appl Biomater. 2008 Oct;87(1):132-8. doi: 10.1002/jbm.b.31082.
PMID: 18395825
responsible party type: Principal Investigator
investigator affiliation: University of Guadalajara
investigator full name: Ivan Segura Duran
investigator title: M.D.
mesh term: Cerebrospinal Fluid Leak
mesh term: Chitosan
sharing ipd: No
ipd description: complete MRI sequences, laboratory studies, visual field tests, complete biomaterial patent registration , clinical reports.