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

April 5, 2019 updated by: Hsu Sheng-Der, Tri-Service General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chitosan gauze
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
Gauze made by chitosan material
Placebo Comparator: Traditional gauze
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
traditional gauze

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Hemostasis
Time Frame: one hour after the surgery
How many second it takes to stop bleeding
one hour after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one hour after the surgery
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.
day0, day7 and day 14.
size of the wound in millimeter
Time Frame: day1, day3, day 5, day7 and day14.
observe the difference of size between different treatment.
day1, day3, day 5, day7 and day14.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Collaborators

National Defense Medical Center, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2015

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

February 10, 2016

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hemostatic-Chitosan-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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