Csf LeakageNCT03280849
Chitosan Scaffold for Sellar Floor Repair in Endoscopic Endonasal Transsphenoidal Surgery
A study testing Implant of bilaminar chitosan scaffold in people with Csf Leakage, run by University of Guadalajara at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Csf Leakage
- What is being tested?
- Implant of bilaminar chitosan scaffold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male/female patient candidate for an endoscopic endonasal transphenoidal surgery, who need repair of the sellar floor as part of the surgical procedure.
Who cannot join
- Diabetes, heart diseases, immunological diseases, infectious diseases, bone diseases.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Csf Leakage
- Being tested
- Implant of bilaminar chitosan scaffold
- Keywords
- chitosan, endoscopic, sellar tumor, biomaterials, transphenoidal
- Medical subject headings
- Cerebrospinal Fluid Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant of bilaminar chitosan scaffoldOther
Also called Endoscopic endonasal transphenoidal surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with bilaminar chitosan implant | Experimental | 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. Receives: Other: Implant of bilaminar chitosan scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain MRI with and without contrast
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the preoperative tumor size
Measured: 1 day preoperative
Brain MRI with and without contrast
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor size
Measured: 1 day postoperative
Head CT scan
Bone window was used to see the repair of bone defect after surgery
Measured: 1 month postoperative
Brain MRI with and without contrast
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
Measured: 1 month postoperative
Brain MRI with and without contrast
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
Measured: 6 months postoperative
Brain MRI with and without contrast
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
Measured: 1 year postoperative
Brain MRI with and without contrast
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
Measured: 2 years postoperative
Head CT scan
Bone window was used to see the repair of bone defect after surgery
Measured: 6months postoperative
Head CT scan
Bone window was used to see the repair of bone defect after surgery
Measured: 1 year postoperative
Head CT scan
Bone window was used to see the repair of bone defect after surgery
Measured: 2 years postoperative
Secondary outcomes (10)
Visual field test
visual field testing looking for compression of optic chiasm
Measured: 1 day preoperative, follow up: 1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Snellen test
visual acuity testing
Measured: 1 day preoperative, follow up: 1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Glasgow scale
level of consciousness
Measured: 1 day preoperative, follow up :1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Endocrinological panel
evaluation of hipofisary function
Measured: 1 day preoperative, follow up : 1 day postoperative, 15 days postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
Blood cell count
For evaluation of any inflammatory reaction or infection before or after the procedure
Measured: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
acute phase reactans
For evaluation of any inflammatory reaction or infection before or after the procedure
Measured: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
blood electrolytesand
evaluation of renal function and as requirement for surgery
Measured: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
liver function test
evaluation of liver function and as requirement for surgery
Measured: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
coagulation test
secondary evaluation of liver function, inflammatory reaction or infection before and after the procedure and as requirement for surgery.
Measured: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
seric creatinine
evaluation of renal function and as requirement for surgery
Measured: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study startJan 2015
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Csf LeakageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Segura Duran, University of Guadalajara
- Investigators
- Rodrigo Ramos Zuñiga, M.D. PhD, Study chair, University of GuadalajaraBrenda Vega Ruiz, PhD, Principal investigator, University of GuadalajaraIvan Segura Duran, M.D., Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280849
- Sponsor's protocol ID
- CI.064.2015
- Status last verified
- Mar 2019
- First submitted
- 4 Sep 2017
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: complete MRI sequences, laboratory studies, visual field tests, complete biomaterial patent registration , clinical reports.
Publications
Gobin AS, Butler CE, Mathur AB. Repair and regeneration of the abdominal wall musculofascial defect using silk fibroin-chitosan blend. Tissue Eng. 2006 Dec;12(12):3383-94. doi: 10.1089/ten.2006.12.3383.
PubMed 17518675Paulo NM, de Brito e Silva MS, Moraes AM, Rodrigues AP, de Menezes LB, Miguel MP, de Lima FG, de Morais Faria A, Lima LM. Use of chitosan membrane associated with polypropylene mesh to prevent peritoneal adhesion in rats. J Biomed Mater Res B Appl Biomater. 2009 Oct;91(1):221-7. doi: 10.1002/jbm.b.31393.
PubMed 19399842Udpa N, Iyer SR, Rajoria R, Breyer KE, Valentine H, Singh B, McDonough SP, Brown BN, Bonassar LJ, Gao Y. Effects of chitosan coatings on polypropylene mesh for implantation in a rat abdominal wall model. Tissue Eng Part A. 2013 Dec;19(23-24):2713-23. doi: 10.1089/ten.TEA.2012.0739. Epub 2013 Aug 21.
PubMed 23859182Tchemtchoua VT, Atanasova G, Aqil A, Filee P, Garbacki N, Vanhooteghem O, Deroanne C, Noel A, Jerome C, Nusgens B, Poumay Y, Colige A. Development of a chitosan nanofibrillar scaffold for skin repair and regeneration. Biomacromolecules. 2011 Sep 12;12(9):3194-204. doi: 10.1021/bm200680q. Epub 2011 Aug 1.
PubMed 21761871Stippler M, Gardner PA, Snyderman CH, Carrau RL, Prevedello DM, Kassam AB. Endoscopic endonasal approach for clival chordomas. Neurosurgery. 2009 Feb;64(2):268-77; discussion 277-8. doi: 10.1227/01.NEU.0000338071.01241.E2.
PubMed 19190456Gardner PA, Kassam AB, Snyderman CH, Carrau RL, Mintz AH, Grahovac S, Stefko S. Outcomes following endoscopic, expanded endonasal resection of suprasellar craniopharyngiomas: a case series. J Neurosurg. 2008 Jul;109(1):6-16. doi: 10.3171/JNS/2008/109/7/0006.
PubMed 18590427Greenfield JP, Anand VK, Kacker A, Seibert MJ, Singh A, Brown SM, Schwartz TH. Endoscopic endonasal transethmoidal transcribriform transfovea ethmoidalis approach to the anterior cranial fossa and skull base. Neurosurgery. 2010 May;66(5):883-92; discussion 892. doi: 10.1227/01.neu.0000368395.82329.c4.
PubMed 20414977Gardner PA, Kassam AB, Thomas A, Snyderman CH, Carrau RL, Mintz AH, Prevedello DM. Endoscopic endonasal resection of anterior cranial base meningiomas. Neurosurgery. 2008 Jul;63(1):36-52; discussion 52-4. doi: 10.1227/01.NEU.0000335069.30319.1E.
PubMed 18728567Simoes MJ, Gartner A, Shirosaki Y, Gil da Costa RM, Cortez PP, Gartner F, Santos JD, Lopes MA, Geuna S, Varejao AS, Mauricio AC. In vitro and in vivo chitosan membranes testing for peripheral nerve reconstruction. Acta Med Port. 2011 Jan-Feb;24(1):43-52. Epub 2011 Feb 28.
PubMed 21672441Meyer C, Stenberg L, Gonzalez-Perez F, Wrobel S, Ronchi G, Udina E, Suganuma S, Geuna S, Navarro X, Dahlin LB, Grothe C, Haastert-Talini K. Chitosan-film enhanced chitosan nerve guides for long-distance regeneration of peripheral nerves. Biomaterials. 2016 Jan;76:33-51. doi: 10.1016/j.biomaterials.2015.10.040. Epub 2015 Oct 21.
PubMed 26517563Zhao Y, Wang Y, Gong J, Yang L, Niu C, Ni X, Wang Y, Peng S, Gu X, Sun C, Yang Y. Chitosan degradation products facilitate peripheral nerve regeneration by improving macrophage-constructed microenvironments. Biomaterials. 2017 Jul;134:64-77. doi: 10.1016/j.biomaterials.2017.02.026. Epub 2017 Feb 22.
PubMed 28456077Ghasemi Hamidabadi H, Rezvani Z, Nazm Bojnordi M, Shirinzadeh H, Seifalian AM, Joghataei MT, Razaghpour M, Alibakhshi A, Yazdanpanah A, Salimi M, Mozafari M, Urbanska AM, Reis RL, Kundu SC, Gholipourmalekabadi M. Chitosan-Intercalated Montmorillonite/Poly(vinyl alcohol) Nanofibers as a Platform to Guide Neuronlike Differentiation of Human Dental Pulp Stem Cells. ACS Appl Mater Interfaces. 2017 Apr 5;9(13):11392-11404. doi: 10.1021/acsami.6b14283. Epub 2017 Mar 27.
PubMed 28117963Rodriguez-Vazquez M, Vega-Ruiz B, Ramos-Zuniga R, Saldana-Koppel DA, Quinones-Olvera LF. Chitosan and Its Potential Use as a Scaffold for Tissue Engineering in Regenerative Medicine. Biomed Res Int. 2015;2015:821279. doi: 10.1155/2015/821279. Epub 2015 Oct 4.
PubMed 26504833Sandoval-Sanchez JH, Ramos-Zuniga R, de Anda SL, Lopez-Dellamary F, Gonzalez-Castaneda R, Ramirez-Jaimes Jde L, Jorge-Espinoza G. A new bilayer chitosan scaffolding as a dural substitute: experimental evaluation. World Neurosurg. 2012 Mar-Apr;77(3-4):577-82. doi: 10.1016/j.wneu.2011.07.007. Epub 2011 Nov 7.
PubMed 22120335Nawrotek K, Marqueste T, Modrzejewska Z, Zarzycki R, Rusak A, Decherchi P. Thermogelling chitosan lactate hydrogel improves functional recovery after a C2 spinal cord hemisection in rat. J Biomed Mater Res A. 2017 Jul;105(7):2004-2019. doi: 10.1002/jbm.a.36067. Epub 2017 Apr 12.
PubMed 28324618
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chitosan Scaffold for Sellar Floor Repair in Endoscopic Endonasal Transsphenoidal Surgery
- ClinicalTrials.gov ID
- NCT03280849
- Acronym / sponsor ID
- CI.064.2015
- Conditions
- Csf Leakage
- Keywords
- chitosan, endoscopic, sellar tumor, biomaterials, transphenoidal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient with bilaminar chitosan implant | Experimental | Other: Implant of bilaminar chitosan scaffoldA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male/female patient candidate for an endoscopic endonasal transphenoidal surgery, who need repair of the sellar floor as part of the surgical procedure.
Key exclusion criteria (1 listed)
- Diabetes, heart diseases, immunological diseases, infectious diseases, bone diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant of bilaminar chitosan scaffoldAlso: Endoscopic endonasal transphenoidal surgeryThe 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. | Other | Patient with bilaminar chitosan implant |
Primary outcome
Brain MRI with and without contrast
Time frame: 1 day preoperative
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the preoperative tumor size
Brain MRI with and without contrast
Time frame: 1 day postoperative
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor size
Head CT scan
Time frame: 1 month postoperative
Bone window was used to see the repair of bone defect after surgery
Brain MRI with and without contrast
Time frame: 1 month postoperative
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
Brain MRI with and without contrast
Time frame: 6 months postoperative
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
Brain MRI with and without contrast
Time frame: 1 year postoperative
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
Brain MRI with and without contrast
Time frame: 2 years postoperative
Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor
Head CT scan
Time frame: 6months postoperative
Bone window was used to see the repair of bone defect after surgery
Head CT scan
Time frame: 1 year postoperative
Bone window was used to see the repair of bone defect after surgery
Head CT scan
Time frame: 2 years postoperative
Bone window was used to see the repair of bone defect after surgery
10 secondary outcomes
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.
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.
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.
Endocrinological panel
Time frame: 1 day preoperative, follow up : 1 day postoperative, 15 days postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
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
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
blood electrolytesand
Time frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
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
coagulation test
Time frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
seric creatinine
Time frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Background: PubMed 17518675Gobin AS, Butler CE, Mathur AB. Repair and regeneration of the abdominal wall musculofascial defect using silk fibroin-chitosan blend. Tissue Eng. 2006 Dec;12(12):3383-94. doi: 10.1089/ten.2006.12.3383.
- Background: PubMed 19399842Paulo NM, de Brito e Silva MS, Moraes AM, Rodrigues AP, de Menezes LB, Miguel MP, de Lima FG, de Morais Faria A, Lima LM. Use of chitosan membrane associated with polypropylene mesh to prevent peritoneal adhesion in rats. J Biomed Mater Res B Appl Biomater. 2009 Oct;91(1):221-7. doi: 10.1002/jbm.b.31393.
- Background: PubMed 23859182Udpa N, Iyer SR, Rajoria R, Breyer KE, Valentine H, Singh B, McDonough SP, Brown BN, Bonassar LJ, Gao Y. Effects of chitosan coatings on polypropylene mesh for implantation in a rat abdominal wall model. Tissue Eng Part A. 2013 Dec;19(23-24):2713-23. doi: 10.1089/ten.TEA.2012.0739. Epub 2013 Aug 21.
- Background: PubMed 21761871Tchemtchoua VT, Atanasova G, Aqil A, Filee P, Garbacki N, Vanhooteghem O, Deroanne C, Noel A, Jerome C, Nusgens B, Poumay Y, Colige A. Development of a chitosan nanofibrillar scaffold for skin repair and regeneration. Biomacromolecules. 2011 Sep 12;12(9):3194-204. doi: 10.1021/bm200680q. Epub 2011 Aug 1.
- Background: PubMed 19190456Stippler M, Gardner PA, Snyderman CH, Carrau RL, Prevedello DM, Kassam AB. Endoscopic endonasal approach for clival chordomas. Neurosurgery. 2009 Feb;64(2):268-77; discussion 277-8. doi: 10.1227/01.NEU.0000338071.01241.E2.
- Background: PubMed 18590427Gardner PA, Kassam AB, Snyderman CH, Carrau RL, Mintz AH, Grahovac S, Stefko S. Outcomes following endoscopic, expanded endonasal resection of suprasellar craniopharyngiomas: a case series. J Neurosurg. 2008 Jul;109(1):6-16. doi: 10.3171/JNS/2008/109/7/0006.
- Background: PubMed 20414977Greenfield JP, Anand VK, Kacker A, Seibert MJ, Singh A, Brown SM, Schwartz TH. Endoscopic endonasal transethmoidal transcribriform transfovea ethmoidalis approach to the anterior cranial fossa and skull base. Neurosurgery. 2010 May;66(5):883-92; discussion 892. doi: 10.1227/01.neu.0000368395.82329.c4.
- Background: PubMed 18728567Gardner PA, Kassam AB, Thomas A, Snyderman CH, Carrau RL, Mintz AH, Prevedello DM. Endoscopic endonasal resection of anterior cranial base meningiomas. Neurosurgery. 2008 Jul;63(1):36-52; discussion 52-4. doi: 10.1227/01.NEU.0000335069.30319.1E.
- Results publication: PubMed 21672441Simoes MJ, Gartner A, Shirosaki Y, Gil da Costa RM, Cortez PP, Gartner F, Santos JD, Lopes MA, Geuna S, Varejao AS, Mauricio AC. In vitro and in vivo chitosan membranes testing for peripheral nerve reconstruction. Acta Med Port. 2011 Jan-Feb;24(1):43-52. Epub 2011 Feb 28.
- Results publication: PubMed 26517563Meyer C, Stenberg L, Gonzalez-Perez F, Wrobel S, Ronchi G, Udina E, Suganuma S, Geuna S, Navarro X, Dahlin LB, Grothe C, Haastert-Talini K. Chitosan-film enhanced chitosan nerve guides for long-distance regeneration of peripheral nerves. Biomaterials. 2016 Jan;76:33-51. doi: 10.1016/j.biomaterials.2015.10.040. Epub 2015 Oct 21.
- Results publication: PubMed 28456077Zhao Y, Wang Y, Gong J, Yang L, Niu C, Ni X, Wang Y, Peng S, Gu X, Sun C, Yang Y. Chitosan degradation products facilitate peripheral nerve regeneration by improving macrophage-constructed microenvironments. Biomaterials. 2017 Jul;134:64-77. doi: 10.1016/j.biomaterials.2017.02.026. Epub 2017 Feb 22.
- Results publication: PubMed 28117963Ghasemi Hamidabadi H, Rezvani Z, Nazm Bojnordi M, Shirinzadeh H, Seifalian AM, Joghataei MT, Razaghpour M, Alibakhshi A, Yazdanpanah A, Salimi M, Mozafari M, Urbanska AM, Reis RL, Kundu SC, Gholipourmalekabadi M. Chitosan-Intercalated Montmorillonite/Poly(vinyl alcohol) Nanofibers as a Platform to Guide Neuronlike Differentiation of Human Dental Pulp Stem Cells. ACS Appl Mater Interfaces. 2017 Apr 5;9(13):11392-11404. doi: 10.1021/acsami.6b14283. Epub 2017 Mar 27.
- website of our institute of traslational neurosciencesLink provided by the sponsor.
- website of our centerLink provided by the sponsor.
- website of our hospital facilitiesLink provided by the sponsor.
- Individual participant dataSharing planned: No. complete MRI sequences, laboratory studies, visual field tests, complete biomaterial patent registration , clinical reports.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Ramos Zuñiga, M.D. PhD study chair
University of Guadalajara
Brenda Vega Ruiz, PhD principal investigator
University of Guadalajara
Ivan Segura Duran, M.D. principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant of bilaminar chitosan scaffold in people with Csf Leakage, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain MRI with and without contrast (time frame: 1 day preoperative). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03280849, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.