NCT03907111

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

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

October 2, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2016

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

April 3, 2019

Last Update Submit

April 5, 2019

Conditions

Hemostasis

Keywords

bleeding wounds, hemostasis, open wounds, infection, antimicrobial

Outcome Measures

Primary Outcomes (1)

  • Time to Hemostasis

    How many second it takes to stop bleeding

    one hour after the surgery

Secondary Outcomes (3)

  • Breeding volume

    one hour after the surgery

  • Relative light units difference

    day0, day7 and day 14.

  • size of the wound in millimeter

    day1, day3, day 5, day7 and day14.

Study Arms (2)

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.

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.

Device: placebo

Interventions

Chitosan GauzeDEVICE

Gauze made by chitosan material

Chitosan gauze
placeboDEVICE

traditional gauze

Traditional gauze

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 20617383BACKGROUND

  • 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.

    PMID: 22212190BACKGROUND

  • 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.

    PMID: 26436948BACKGROUND

  • 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.

    PMID: 15512779BACKGROUND

  • 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.

    PMID: 17647243BACKGROUND

  • 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.

    PMID: 23861704BACKGROUND

  • 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.

    PMID: 24551807BACKGROUND

  • 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.

    PMID: 24587972BACKGROUND

MeSH Terms

Conditions

Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Each of the participants was been treated with 2 different treatments on different areas of the same wound at the same time.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician, department of traumatology

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 8, 2019

Study Start

October 2, 2015

Primary Completion

December 31, 2015

Study Completion

February 10, 2016

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share