Wound HealingNCT01895933
Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel
A study testing 5ml surgishield in people with Wound Healing, run by D.med at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Wound Healing
- What is being tested?
- 5ml surgishield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Mar 2012to Apr 2013
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 21 years of age
- both side sinusitis
- will undergo endoscopic sinus surgery
- volunteers with informed consent and signature
Who cannot join
- suppressed immunity patient
- systemic grave condition
- pregnant
- cancer
- severe disease patients
- asthma patients
Show all 25Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Dankook University Hospital
Cheonan, Chungcheongnam-do, 31116
Chungbook National University Hospital
Chungju, ChoongChungBukDo
About this study
Official 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
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.
- Conditions
- Wound Healing
- Being tested
- 5ml surgishield
- Keywords
- Investigational device (chitosan gel), Wound healing, Endoscopic sinus surgery, SurgiShield
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Active / control | Active comparator | One side has been treated with SurgiShield Receives: Device: 5ml surgishield |
| No intervention | No intervention | One side has no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion Rate
Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery)
Measured: at 2 weeks
Secondary outcomes (1)
Adhesion Rate
Adhesion rate at 1 and 4 weeks after ESS(endoscopic sinus surgery) Bleeding score at 0,2,4,6,8,10 minutes after ESS
Measured: at 1 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- D.med
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dankook University, Chungbuk National University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895933
- Sponsor's protocol ID
- DMED-SS001
- Status last verified
- Dec 2023
- First submitted
- 8 Jul 2013
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01895933
- Acronym / sponsor ID
- DMED-SS001
- Conditions
- Wound Healing
- Keywords
- Investigational device (chitosan gel), Wound healing, Endoscopic sinus surgery, SurgiShield
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- D.medIndustry (pharma, biotech, devices)
- Collaborators
- Dankook University, Chungbuk National University
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Jul 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active / control | Active comparator | Device: 5ml surgishieldOne side has been treated with SurgiShield |
| No intervention | No intervention | –One side has no intervention |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- older than 21 years of age
- both side sinusitis
- will undergo endoscopic sinus surgery
- volunteers with informed consent and signature
Key exclusion criteria (25 listed)
- suppressed immunity patient
- systemic grave condition
- pregnant
- cancer
- severe disease patients
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 |
|---|---|---|
| 5ml surgishieldin 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 | Device | Active / control |
Primary outcome
Adhesion Rate
Time frame: at 2 weeks
Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery)
1 secondary outcome
Adhesion Rate
Time frame: at 1 and 4 weeks
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 8 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5ml surgishield in people with Wound Healing, run by D.med at 2 sites in South Korea.
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 4 inclusion and 25 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Adhesion Rate (time frame: at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2023.