- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884919
Develop the First Aid Medical Supplies for Hemostasis and Bacteriostasis With Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This trial is performed when the subjects undergoing a cesarean section at Tri-Service General Hospital, Taipei, Taiwan (R.O.C). After disinfection of the surgical wound, regular gauze and chitosan dressings are directly and simultaneously placed over the disinfected wound with finger pressure for 3 min, immediately after the dissection. The regular gauze dressing is placed on half side of the surgical wound, while the chitosan dressing is placed on another half side of the wound. After 3 min, the pressure is stopped and the doctors will photograph and observe both dressings whether the bleeding has stopped. If the bleeding on the surface of the wound has stopped after 20 s, the bleeding is considered to have stopped and the wound is then treated according to the scheduled surgical procedure. If the bleeding has not stopped, finger pressure to stop bleeding will be given for 5 min. Then, after 5 minutes, the pressure is stopped and the bleeding condition is observed. If the bleeding has stopped after 20 s, the bleeding of the wound is judged to have stopped and the subsequent surgery will be performed. However, if it still bleeds, both dressings will be replaced and do the same for another 5 min. (Note) Depending on the physiological parameters of each patient, the decision can be determined by the physician; if bleeding or hematoma occurs, the patient will be treated according to hospital procedure until the symptoms are relieved, and evaluate whether the test should be stopped.
The postoperative wound will be dressed with regular gauze and chitosan dressings and the wound condition will be recorded on day 0 of the trial. The dressing is daily changed by replacing regular gauze and chitosan dressings and by performing wound care. The test of the dressing sample will be taken for bacterial analysis. If there are symptoms of infection after 14 days of this test, the wound will be treated in accordance with the clinical routine wound treatment. (Note) If the wound condition shows serious infection during the dressing change process, the treatment should be carried out according to the clinical routine treatment method, and it is determined and evaluated whether to stop the test. (Note) If the patient's psychological stress is affected during the trial, the physician will explain and determine whether the trial must be stopped.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sheng-Der Hsu
- Phone Number: 886-987860386
- Email: f1233j@yahoo.com.tw
Study Contact Backup
- Name: Ya-Chi Liu
- Phone Number: 18681 886-2-87923100
- Email: hotcgin0067@gmail.com
Study Locations
-
-
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Taipei, Taiwan, 114
- Recruiting
- National Defense of Medical Center, Tri-Service General Hospital
-
Contact:
- Sheng-Der Hsu
- Phone Number: 886-987860386
- Email: f1233j@yahoo.com.tw
-
Contact:
- Ya-Chi Liu
- Phone Number: 18681 886-2-87923100
- Email: hotcgin0067@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The subject is aged between 20 and 80 years old.
- Patients who need a cesarean section.
- The expected size of the wound is about 5 cm or more in length and 2 cm or more in width.
Exclusion Criteria:
- Patients with a history of allergy to chitin components such as shrimp and crab.
- Patients with blood clotting disorders.
- Vulnerable groups.
- Patients with unstable signs of life.
Study Plan
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 |
---|---|
Placebo Comparator: Regular Gauze Treatment
Participants who undergo a cesarean section are first dissected in about 5 cm length and 2 cm width and receive a regular gauze made of traditional cotton yarn.
The regular gauze is applied on the half side of the wound.
|
Regular gauze
|
Experimental: Chitosan Dressing Treatment
Participants who undergo a cesarean section are first dissected in about 5 cm length and 2 cm width and receive a chitosan dressing made of chitosan material.
The chitosan dressing is applied on another half side of the wound.
|
Dressing made of chitosan material
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin Assay
Time Frame: 3 up to 13 minutes
|
After 3, 5, and additional 5 minutes, consecutively depending on the patients' conditions, the use of regular gauze and chitosan dressings to compress the abdominal surgical wounds are incubated in jars containing 0.9% (w/v) saline solution for 1, 3, 5, and 10 minutes, respectively.
1 mL solution of the dressing incubation is collected and evaluated using a hemoglobin standard (H7379, Sigma-Aldrich; Merck KGaA, Darmstadt, Germany).
The hemoglobin concentration is measured by examining the optical density at 540 nm wavelength.
|
3 up to 13 minutes
|
Adenosine Triphosphate (ATP) Assay
Time Frame: Up to 8 days
|
This assay is performed to evaluate and compare antimicrobial properties of both dressings.
Adenosine triphosphate (ATP) bioluminescence assay expressed in Relative Fluorescence Units (RFU) is used to measure the number of bacteria by using ATP luminometer (LuciPac Pen PD 30, Kikkoman Biochemifa Co., Tokyo, Japan).
|
Up to 8 days
|
Phylogenetic of Microbial Community
Time Frame: Up to 3 days
|
Wound-contacted dressings of patients are collected on day 1 and day 3 postoperation and kept at 4°C within an hour processed for genomic DNA isolation using DNeasy Blood & Tissue kit (QIAGEN, Germany).
Amplification of 16S-rRNA-genes of distinct regions V3-V4 is conducted using specific primer 16S V3+V4: 314F-806R with the barcode.
Phusion® High-Fidelity PCR Master Mix (New England Biolabs) is then used for all PCR reactions.
Subsequently, 300bp paired-end raw reads are implemented for amplicon sequencing.
Finally, the entire paired-end reads are incorporated using FLASH v.1.2.7.
|
Up to 3 days
|
Heat Map Analysis
Time Frame: Up to 6 days
|
The heat map is analyzed using an R package to acquire the distribution of bacteria population in wound-contacted dressings.
This analysis results the distribution of heat produced by bacteria population that is scaled from -1 to 1 indicating the abundance of each genus of bacteria from the lowest temperature to the highest temperature.
|
Up to 6 days
|
Partial Least Squares Discriminant Analysis (PLS-DA)
Time Frame: Up to 6 days
|
PLS-DA is analyzed using PLS toolbox (Eigenvector Research Incorporated Wenatchee, WA, USA) for Matlab® R2009b software (Mathworks Inc., Natick MA, USA) to get the discriminant of bacterial community between the wound-contacted dressing.
|
Up to 6 days
|
UpSet Plot
Time Frame: Up to 6 days
|
The UpSet plot of Bacteria Operational Taxonomy Units is produced in R using UpSetR.
This results intersection sizes of bacteria among the experiment groups.
|
Up to 6 days
|
Statistical Analysis
Time Frame: Up to 8 days
|
Statistical calculations are performed using SPSS software version 21 (SPSS, Chicago, IL, USA) and written in the form of mean ± standard error of the mean.
Data means are compared by one-way or two-way analysis of variance (ANOVA) among two or more than two groups for statistical comparison.
The significance level is set at p < 0.05.
|
Up to 8 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kang X, Liu G, Liu Y, Xu Q, Zhang M, Fang M. Transcriptome profile at different physiological stages reveals potential mode for curly fleece in Chinese tan sheep. PLoS One. 2013 Aug 26;8(8):e71763. doi: 10.1371/journal.pone.0071763. eCollection 2013.
- Chen B, Gao LL, Pan Q. Woody forages effect the intestinal bacteria diversity of golden pompano Trachinotus ovatus. AMB Express. 2018 Feb 27;8(1):29. doi: 10.1186/s13568-018-0550-2.
- Vijayalakshmi S, Adeyemi DE, Choi IY, Sultan G, Madar IH, Park MK. Comprehensive in silico analysis of lactic acid bacteria for the selection of desirable probiotics. LWT. 2020; 130:109617.
- Akanny, E, Bonhommé, A, Commun, C, et al. Surface-enhanced Raman spectroscopy using uncoated gold nanoparticles for bacteria discrimination. J Raman Spectrosc. 2020; 51: 619- 629.
- Ramadan Z, Jacobs D, Grigorov M, Kochhar S. Metabolic profiling using principal component analysis, discriminant partial least squares, and genetic algorithms. Talanta. 2006 Feb 28;68(5):1683-91. doi: 10.1016/j.talanta.2005.08.042. Epub 2005 Sep 19.
- Ruparell A, Inui T, Staunton R, Wallis C, Deusch O, Holcombe LJ. The canine oral microbiome: variation in bacterial populations across different niches. BMC Microbiol. 2020 Feb 28;20(1):42. doi: 10.1186/s12866-020-1704-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chitosan-Microbiome
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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