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OpenTrials
Completed

NCT Number: NCT03907111

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

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.

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Chitosan Gauze

Device

Gauze made by chitosan material

PLACEBO

Device

traditional gauze

Primary outcomes

  1. Time to Hemostasis

    Time frame: one hour after the surgery

    How many second it takes to stop bleeding

Secondary outcomes

  1. Breeding volume

    Time frame: one hour after the surgery

    the weight gain of the gauze from it been administrated on the wound until the hemostasis of the wound.

  2. Relative light units difference

    Time frame: day0, day7 and day 14.

    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.

  3. size of the wound in millimeter

    Time frame: day1, day3, day 5, day7 and day14.

    observe the difference of size between different treatment.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Collaborators

  • National Defense Medical Center, Taiwan

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 8, 2019
Registry last updated
Apr 9, 2019

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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