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Clinical Trials/NCT01895933
NCT01895933
Completed
Not Applicable

The Aim of This Study is to Evaluate the Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel Made by D Med

D.med2 sites in 1 country33 target enrollmentMarch 2012
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ConditionsWound Healing

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wound Healing
Sponsor
D.med
Enrollment
33
Locations
2
Primary Endpoint
Adhesion Rate
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after endoscopic sinus surgery.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
April 2013
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
D.med
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •older than 21 years of age
  • •both side sinusitis
  • •will undergo endoscopic sinus surgery
  • •volunteers with informed consent and signature

Exclusion Criteria

  • •suppressed immunity patient
  • •systemic grave condition
  • •severe disease patients
  • •asthma patients
  • •cystic fibrosis
  • •ciliary immobility syndrome
  • •neutropenia neutrophil
  • •immunoglobulin deficiency
  • •wound healing immune disease
  • •severe liver disease

Outcomes

Primary Outcomes

Adhesion Rate

Time Frame: at 2 weeks

Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery)

Secondary Outcomes

  • Adhesion Rate(at 1 and 4 weeks)

Study Sites (2)

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