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

Hemostasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907111
• Other study ID #: Hemostatic-Chitosan-2015
• Status: Completed
• Phase: N/A
• Start date: October 2, 2015
• Est. completion date: February 10, 2016

Study information

• Verified date: April 2019
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 10, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Have history of allergy to shrimp, crab and other chitins.

• Patients with blood clotting disorders

• Vulnerable group

• Patients with unstable vital sign

Related Conditions & MeSH terms

• Hemostasis

Intervention

Device:
• Chitosan Gauze
Gauze made by chitosan material
• placebo
traditional gauze

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tri-Service General Hospital	National Defense Medical Center, Taiwan

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Koca Kutlu A, Ceçen D, Gürgen 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Hemostasis	How many second it takes to stop bleeding	one hour after the surgery
Secondary	Breeding volume	the weight gain of the gauze from it been administrated on the wound until the hemostasis of the wound.	one hour after the surgery
Secondary	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.	day0, day7 and day 14.
Secondary	size of the wound in millimeter	observe the difference of size between different treatment.	day1, day3, day 5, day7 and day14.