NCT01895933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

July 8, 2013

Last Update Submit

December 3, 2023

Conditions

Wound Healing

Keywords

Investigational device (chitosan gel)Wound healingEndoscopic sinus surgerySurgiShield

Outcome Measures

Primary Outcomes (1)

  • Adhesion Rate

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

    at 2 weeks

Secondary Outcomes (1)

  • Adhesion Rate

    at 1 and 4 weeks

Study Arms (2)

Active / control

ACTIVE COMPARATOR

One side has been treated with SurgiShield

Device: 5ml surgishield

No intervention

NO INTERVENTION

One side has no intervention

Interventions

5ml surgishieldDEVICE

in the case of active, apply solution type adhesion barrier to merocel and pack 5ml of adhesion inhibitor Surgi Shield on the surgical site merocel in the inflated state maintained for 36\~48 hours, remove packing then solution type adhesion inhibitor is to be injected in to the surgical site

Active / control

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • suppressed immunity patient
  • systemic grave condition
  • pregnant
  • cancer
  • severe disease patients
  • asthma patients
  • AIDS
  • cystic fibrosis
  • ciliary immobility syndrome
  • neutropenia neutrophil
  • immunoglobulin deficiency
  • wound healing immune disease
  • severe liver disease
  • severe kidney disease
  • lymph or blood clotting disorder or patients treated with coagulants
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chungbook National University Hospital

Chungju, ChoongChungBukDo, South Korea

Location

Dankook University Hospital

Cheonan, Chungcheongnam-do, 31116, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 11, 2013

Study Start

March 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

KR(2)