CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1 enrolled
Drug / intervention
Implant of bilaminar chitosan scaffoldother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03280849
NCT03280849N/ACompleted

Chitosan Scaffold for Sellar Floor Repair in Endoscopic Endonasal Transsphenoidal Surgery

University of Guadalajara·interventional·Posted Sep 13, 2017·Updated Mar 14, 2019

In Brief

A clinical study evaluating Implant of bilaminar chitosan scaffold for Csf Leakage. Completed, enrolled 1 participant across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCsf Leakage
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 13, 2017
Enrollment StartJan 1, 2015
Primary CompletionJan 1, 2017
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 8.8 years ago

Interventions

Implant of bilaminar chitosan scaffoldother

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.