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OpenTrials
Completed

NCT Number: NCT01895933

Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel

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.

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Key information

Conditions

Wound Healing

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chungbook National University Hospital, Chungju, ChoongChungBukDo, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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
  • patients taking oral or parenteral glucose for diabetes thrombocytopenia
  • infectious disease
  • currently lactating
  • severe septal deviation
  • case where there is a severe difference in sinusitis state between sides of nose: there is a 3 or more score difference on the Lund-Mackey CT scan scoring system PNS(ParaNasalSinus)
  • shellfish allergy
  • food allergy
  • had endoscopic sinus surgery in the past
  • patient with large sinus polyps
  • patients who have received treatment for extrasinus complication

Treatment and study plan

5ml surgishield

Device

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

Primary outcomes

  1. Adhesion Rate

    Time frame: at 2 weeks

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

Secondary outcomes

  1. Adhesion Rate

    Time frame: at 1 and 4 weeks

    Adhesion rate at 1 and 4 weeks after ESS(endoscopic sinus surgery) Bleeding score at 0,2,4,6,8,10 minutes after ESS

Sponsors and collaborators

Lead sponsor

D.med

Industry

Collaborators

  • Chungbuk National University
  • Dankook University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2013
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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