Develop the First Aid Medical Supplies for Hemostasis and Bacteriostasis With Clinical Trial

NCT04884919 | Unknown

• 1 other identifier: Chitosan-Microbiome
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The current development of hemostatic and open wound infection care strategies will focus on enhancing the efficiency of hemostasis for internal bleeding, relieving pain, avoiding wound infection, and promoting wound healing. As the social environment changes, the demand for hemostatic techniques and wound healing is increasing. Thus, hemostatic techniques are needed to be integrated with functional functions for usual trauma care, and the wound care strategies that can inhibit and reduce infection while helping to facilitate wound healing are needed to be developed to ensure the safety of human life. Therefore, this trial aims to develop new biofiber hemostatic dressings for hemostasis and open wound care. The comparisons of hemostatic and antibacterial effects, hemostatic time, wound infection status, wound bacteria count, and wound adhesion situation obtained from this clinical trial are expected able to establish a better rapid hemostatic strategy and wound infection care strategy.

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (7)

• Hemoglobin Assay

  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

  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

  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

  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)

  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

  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

  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

Study Arms (2)

Regular Gauze Treatment

PLACEBO COMPARATOR

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.

Device: Regular Gauze

Chitosan Dressing Treatment

EXPERIMENTAL

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.

Device: Chitosan Dressing

Interventions

Regular Gauze DEVICE

Regular gauze

Regular Gauze Treatment

Chitosan Dressing DEVICE

Dressing made of chitosan material

Chitosan Dressing Treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

National Defense of Medical Center, Tri-Service General Hospital

Taipei, 114, Taiwan

RECRUITING

Related Publications (6)

• 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.

  PMID: 23990983 BACKGROUND

• 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.

  PMID: 29484505 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18970515 BACKGROUND

• 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.

  PMID: 32111160 BACKGROUND

Central Study Contacts

Sheng-Der Hsu

CONTACT

886-987860386; f1233j@yahoo.com.tw

Ya-Chi Liu

CONTACT

886-2-87923100; hotcgin0067@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Each of the participants is treated with 2 different treatments on different areas of the same wound at the same time.

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 13, 2021
• Study Start: May 10, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

TW (1)