HemostasisNCT03907111

Compare the Hemostatic Effectiveness of Chitosan Gauze With Traditional Gauze on Open Wound on 10 Participants.

A study testing Chitosan Gauze in people with Hemostasis, run by Tri-Service General Hospital (TSGH).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study recruited 10 subject participants to compare the hemostasis gauze made by chitosan with traditional cotton gauze to see which one is better in bleeding time, bleeding volume, wound infection and wound healing speed when it is used in open wound treatment. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hemostasis
What is being tested?: Chitosan Gauze
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: No sites listed yet
Study dates: 2 Oct 2015to 10 Feb 2016
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients need laparotomy, with the expected wound size bigger than 5 cm in length and 2 cm in width.

Who cannot join

Have history of allergy to shrimp, crab and other chitins.
Patients with blood clotting disorders
Vulnerable group
Patients with unstable vital sign

About this study

Official title: Develop the Biologic-fibrotic Dressing on War Open Bleeding Wounds for Hemostasis.

Read the detailed description

open wound bleeding and infection care policy development is focusing on efficiency to strengthen internal bleeding, pain, avoidance of infection and promoting wound healing wound. With the changes in the social environment, people caring for hemostasis and wound healing have become increasingly demanding. Presently, studies generally aim to stop the bleeding using trauma care technology and functional capabilities combined with each other as well as inhibit lower infection and can also help assist healing wounds care strategy for the protection of human lives. Therefore, the goal of the plan is to establish new care strategies on open wounds infection to stop the bleeding and to improve the health and safety of the people. The researchers will choose the general biological hemostatic gauze to conduct clinical trials comparing the clinical hemostasis focusing on bleeding time, wound infection in the wound and the wound bacteria penetrating situations in the hope to build a better strategy in rapid hemostasis and wound infection care strategy.

Conditions: Hemostasis
Being tested: Chitosan Gauze, placebo
Keywords: bleeding wounds, hemostasis, open wounds, infection, antimicrobial
Medical subject headings: Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chitosan GauzeDevice
Gauze made by chitosan material
placeboDevice
traditional gauze

Study groups in NCT03907111
Study group	Role	What they receive
Chitosan gauze	Experimental	100cm^2 Gauze made by chitosan material. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care. Receives: Device: Chitosan Gauze
Traditional gauze	Placebo comparator	100cm^2 Gauze made by traditional cotton yarn. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care. Receives: Device: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Hemostasis
How many second it takes to stop bleeding
Measured: one hour after the surgery

Secondary outcomes (3)

Breeding volume
the weight gain of the gauze from it been administrated on the wound until the hemostasis of the wound.
Measured: one hour after the surgery
Relative light units difference
compare the relative light unit(RLU, relative light units, is by detecting the ATP concentration in the samples to determine the relative bacteria number, kikkoman PD-30) difference on the gauze collected at the daily wound care between chitosan gauze and traditional gauze.
Measured: day0, day7 and day 14.
size of the wound in millimeter
observe the difference of size between different treatment.
Measured: day1, day3, day 5, day7 and day14.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 201510 Feb 2016

First posted8 Apr 2019
Study start2 Oct 2015
Primary completion31 Dec 2015
Study completion10 Feb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for HemostasisStudies 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: Non-randomised
Intervention model: Parallel groups
Model description: Each of the participants was been treated with 2 different treatments on different areas of the same wound at the same time.
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03907111
Sponsor's protocol ID: Hemostatic-Chitosan-2015
Status last verified: Apr 2019
First submitted: 3 Apr 2019
Last updated: 9 Apr 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hattori H, Amano Y, Nogami Y, Takase B, Ishihara M. Hemostasis for severe hemorrhage with photocrosslinkable chitosan hydrogel and calcium alginate. Ann Biomed Eng. 2010 Dec;38(12):3724-32. doi: 10.1007/s10439-010-0121-4. Epub 2010 Jul 9.
PubMed 20617383
Charlesworth TM, Agthe P, Moores A, Anderson DM. The use of haemostatic gelatin sponges in veterinary surgery. J Small Anim Pract. 2012 Jan;53(1):51-6. doi: 10.1111/j.1748-5827.2011.01162.x.
PubMed 22212190
Goyal AK, Garg T, Rath G, Gupta UD, Gupta P. Development and Characterization of Nanoembedded Microparticles for Pulmonary Delivery of Antitubercular Drugs against Experimental Tuberculosis. Mol Pharm. 2015 Nov 2;12(11):3839-50. doi: 10.1021/acs.molpharmaceut.5b00016. Epub 2015 Oct 5.
PubMed 26436948
Bozkir A, Saka OM. Chitosan-DNA nanoparticles: effect on DNA integrity, bacterial transformation and transfection efficiency. J Drug Target. 2004 Jun;12(5):281-8. doi: 10.1080/10611860410001714162.
PubMed 15512779
Wang CC, Su CH, Chen CC. Water absorbing and antibacterial properties of N-isopropyl acrylamide grafted and collagen/chitosan immobilized polypropylene nonwoven fabric and its application on wound healing enhancement. J Biomed Mater Res A. 2008 Mar 15;84(4):1006-17. doi: 10.1002/jbm.a.31482.
PubMed 17647243
Koca Kutlu A, Cecen D, Gurgen SG, Sayin O, Cetin F. A Comparison Study of Growth Factor Expression following Treatment with Transcutaneous Electrical Nerve Stimulation, Saline Solution, Povidone-Iodine, and Lavender Oil in Wounds Healing. Evid Based Complement Alternat Med. 2013;2013:361832. doi: 10.1155/2013/361832. Epub 2013 Jun 3.
PubMed 23861704
Kordjazi M, Shabanpour B, Zabihi E, Faramarzi MA, Feizi F, Ahmadi Gavlighi H, Feghhi MA, Hosseini SA. Sulfated polysaccharides purified from two species of padina improve collagen and epidermis formation in the rat. Int J Mol Cell Med. 2013 Fall;2(4):156-63.
PubMed 24551807
Junker JP, Kamel RA, Caterson EJ, Eriksson E. Clinical Impact Upon Wound Healing and Inflammation in Moist, Wet, and Dry Environments. Adv Wound Care (New Rochelle). 2013 Sep;2(7):348-356. doi: 10.1089/wound.2012.0412.
PubMed 24587972

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hemostasis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Develop the Biologic-fibrotic Dressing on War Open Bleeding Wounds for Hemostasis.
ClinicalTrials.gov ID: NCT03907111
Acronym / sponsor ID: Hemostatic-Chitosan-2015
Conditions: Hemostasis
Keywords: bleeding wounds, hemostasis, open wounds, infection, antimicrobial
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Tri-Service General Hospital (TSGH)University, hospital or other
Collaborators: National Defense Medical Center, Taiwan
Study start: 2 Oct 2015 (actual)
Primary completion: 31 Dec 2015 (actual)
Study completion: 10 Feb 2016 (actual)
First posted: 8 Apr 2019 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Each of the participants was been treated with 2 different treatments on different areas of the same wound at the same time.

Arm	Type	Receives
Chitosan gauze	Experimental	Device: Chitosan Gauze100cm^2 Gauze made by chitosan material. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care.
Traditional gauze	Placebo comparator	Device: placebo100cm^2 Gauze made by traditional cotton yarn. Administrate it on surgical wound after surgery directly. Change it daily with necessary wound care.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients need laparotomy, with the expected wound size bigger than 5 cm in length and 2 cm in width.

Key exclusion criteria (4 listed)

Have history of allergy to shrimp, crab and other chitins.
Patients with blood clotting disorders
Vulnerable group
Patients with unstable vital sign

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
Chitosan GauzeGauze made by chitosan material	Device	Chitosan gauze
placebotraditional gauze	Device	Traditional gauze

Primary outcome

Time to Hemostasis
Time frame: one hour after the surgery
How many second it takes to stop bleeding

3 secondary outcomes

Breeding volume
Time frame: one hour after the surgery
Relative light units difference
Time frame: day0, day7 and day 14.
size of the wound in millimeter
Time frame: day1, day3, day 5, day7 and day14.

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 9 Apr 2019.
Background: PubMed 20617383Hattori H, Amano Y, Nogami Y, Takase B, Ishihara M. Hemostasis for severe hemorrhage with photocrosslinkable chitosan hydrogel and calcium alginate. Ann Biomed Eng. 2010 Dec;38(12):3724-32. doi: 10.1007/s10439-010-0121-4. Epub 2010 Jul 9.
Background: PubMed 22212190Charlesworth TM, Agthe P, Moores A, Anderson DM. The use of haemostatic gelatin sponges in veterinary surgery. J Small Anim Pract. 2012 Jan;53(1):51-6. doi: 10.1111/j.1748-5827.2011.01162.x.
Background: PubMed 26436948Goyal AK, Garg T, Rath G, Gupta UD, Gupta P. Development and Characterization of Nanoembedded Microparticles for Pulmonary Delivery of Antitubercular Drugs against Experimental Tuberculosis. Mol Pharm. 2015 Nov 2;12(11):3839-50. doi: 10.1021/acs.molpharmaceut.5b00016. Epub 2015 Oct 5.
Background: PubMed 15512779Bozkir A, Saka OM. Chitosan-DNA nanoparticles: effect on DNA integrity, bacterial transformation and transfection efficiency. J Drug Target. 2004 Jun;12(5):281-8. doi: 10.1080/10611860410001714162.
Background: PubMed 17647243Wang CC, Su CH, Chen CC. Water absorbing and antibacterial properties of N-isopropyl acrylamide grafted and collagen/chitosan immobilized polypropylene nonwoven fabric and its application on wound healing enhancement. J Biomed Mater Res A. 2008 Mar 15;84(4):1006-17. doi: 10.1002/jbm.a.31482.
Background: PubMed 23861704Koca Kutlu A, Cecen D, Gurgen SG, Sayin O, Cetin F. A Comparison Study of Growth Factor Expression following Treatment with Transcutaneous Electrical Nerve Stimulation, Saline Solution, Povidone-Iodine, and Lavender Oil in Wounds Healing. Evid Based Complement Alternat Med. 2013;2013:361832. doi: 10.1155/2013/361832. Epub 2013 Jun 3.
Background: PubMed 24551807Kordjazi M, Shabanpour B, Zabihi E, Faramarzi MA, Feizi F, Ahmadi Gavlighi H, Feghhi MA, Hosseini SA. Sulfated polysaccharides purified from two species of padina improve collagen and epidermis formation in the rat. Int J Mol Cell Med. 2013 Fall;2(4):156-63.
Background: PubMed 24587972Junker JP, Kamel RA, Caterson EJ, Eriksson E. Clinical Impact Upon Wound Healing and Inflammation in Moist, Wet, and Dry Environments. Adv Wound Care (New Rochelle). 2013 Sep;2(7):348-356. doi: 10.1089/wound.2012.0412.
Individual participant dataSharing planned: No

Related trials for Hemostasis

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis

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.

Questions about this trial

What is this clinical trial studying?

A study testing Chitosan Gauze in people with Hemostasis, run by Tri-Service General Hospital (TSGH).

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 1 inclusion and 4 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 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Time to Hemostasis (time frame: one hour after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03907111, which also lists 8 linked publications.

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 9 Apr 2019.