WoundNCT05924867
Plasma Activated Saline in Wound Treatment
A study testing plasma activated saline and Routine nursing in people with Wound and Wound Infection, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This is a prospective, open-label, randomized, parallel controlled clinical trial. The purpose of this study is to understand the application value of plasma-activated normal saline in the treatment of different types of wounds. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Wound, Wound Infection, Wound Heal
- What is being tested?
- plasma activated saline and Routine nursing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria
- Group of postoperative incision infection
- Age ≥18 years old, ≤75 years old, gender unlimited.
- Clinical diagnosis of postoperative incision infection.
- Must be no significant risk of head trauma or closed injury to the chest and abdomen.
- Fully understand the study content and subjects' rights and interests, and sign the informed consent.
- Group of postoperative incision fat liquefaction
- Age ≥18 years old, ≤75 years old, gender unlimited.
- Clinical diagnosis of postoperative incision fat liquefaction.
- Must be no incision infection or organ infection was involved in deep surgery, and no other serious complications occurred.
- Must be no significant risk of head trauma or closed injury to the chest and abdomen.
- Fully understand the study content and subjects' rights and interests, and sign the informed consent.
- Group of infectious ulcers
- Age ≥18 years old, ≤75 years old, gender unlimited.
- Clinical diagnosis of superficial skin ulcer infection caused by various causes, which can have one or more wounds.
- The formation time of the wound surface exceeds 1 month.
- Fully understand the study content and subjects' rights and interests, and sign the informed consent.
- Exclusion Criteria
- Allergic to multiple drugs, dressings, gels or materials used in this study.
- Functional injury of cardiopulmonary system, with obvious risk of craniocerebral trauma or severe closed injury of chest and abdomen.
- Severe malnutrition, hypoproteinemia, moderate to severe anemia.
- Pregnant or lactating women (lactating female subjects can still be included if they agree to stop breastfeeding during the treatment period and within one week after the last medication).
- Patients with active wound bleeding, poor mental condition and critical condition.
- Poor glycemic control of diabetes mellitus; Severe malnutrition, hypoproteinemia, moderate and severe anemia.
- The presence of inflammatory skin diseases, such as atopic dermatitis or eczema, that affect efficacy and safety evaluation.
- Poor glycemic control of diabetes mellitus; Severe malnutrition, severe cardiopulmonary disease, hypertension, widespread local necrosis requiring immediate toe amputation.
- Combined with anaerobic bacteria infection, wet gangrene, abdominal infection, hematogenous infection, and intra-articular infection.
- Ulcers caused by diabetic feet and malignant tumors.
- History of glucocorticoid use and anticoagulant drug use within 12 months before enrollment.
- History of immune disease or immunosuppressant use.
- Poor compliance due to cognitive impairment or mental illness.
- Any conditions that the investigator considered might increase the risk to the subject or affect the evaluation of efficacy.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 710061
Chang Liu, PhD, 0086-18991232095, liuchangfh@xjtu.edu.cn
About this study
Official title: Application of Plasma Activated Saline in Wound Treatment
This is a prospective, open-label, randomized, parallel controlled clinical trial. The purpose of this study is to understand the application value of plasma-activated normal saline in the treatment of different types of wounds. The main questions it aims to answer are:
- What is the effect of plasma activated normal saline in promoting wound healing of different types?
- What is the safety of plasma activated normal saline in the treatment of wound surface? Subjects will be randomly divided into the intervention group and the control group. The intervention group will receive wound treatment with plasma activated normal saline, and the control group will receive routine dressing change treatment.
Read the detailed description
As the population ages and antibiotic resistance increases, the chance of co-infection of various types of wounds increases greatly, resulting in prolonged wounds healing and eventually leading to bloodstream infections caused by germs, which can develop into life-threatening sepsis in severe cases. Plasma active saline is rich in reactive oxygen groups (ROS) and reactive nitrogen groups (RNS). It has good anti-inflammatory effect and is a potential new material to control wound infection and promote wound healing. Therefore, the purpose of this study was to apply plasma-activated water to different types of wounds and evaluate the effect of plasma-activated water on promoting healing of different types of wounds. And security issues in the application process.
This study is a prospective, open label, randomized, parallel controlled trial. This study is expected to include 162 subjects, including 46 patients with postoperative incision infection, 34 patients with postoperative incision fat liquefaction, and 82 patients with cutaneous infectious ulcer. The participants will be randomly divided into intervention group and control group by grouping randomized method. The intervention group will be treated with plasma activated water flushing and wet compress, and the control group will be treated with routine dressing change. The investigators will collect participants' wound conditions, blood, microbiological tests and other relevant indicators during treatment and follow-up.
To analyze the efficacy and safety of plasma-activated saline in the treatment of different wounds, the investigators will use independent sample T-test and K-M methods to compare the efficacy of the two groups, use descriptive analysis to represent the type and frequency of adverse events.
- Conditions
- Wound, Wound Infection, Wound Heal
- Being tested
- plasma activated saline, Routine nursing
- Medical subject headings
- Wounds and Injuries, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma activated salineOther
The plasma activated normal saline used in the intervention was prepared by a self-made machine, and the safety of the plasma activated water produced by the machine has passed the national quality inspection.
Routine nursingOther
For postoperative incision infection group and infected ulcer group, conventional dressing change treatment was given, namely chlorhexidine disinfectant washing, drainage and bandaging; For the fat liquefaction group, conventional treatment was given, namely negative pressure suction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The wounds of participants in the postoperative incision infection group and ulcer infection group will be given plasma activated saline irrigation (100 ml plasma activated saline for every 10 cm2 wound), drainage, and wet compress. The wounds of participants in the fat liquefaction group will be uniformly rinsed with plasma saline for 5-10 min to clean the incision, then drained and suction with negative pressure.
The researchers will determine the dressing change time according to the size of the patient's wound and the number of secretions, starting every day or every other day, and waiting for the incision to be fresh or less secretions at an interval of 2-3 days. Receives: Other: plasma activated saline |
| Control group | Active comparator | The wounds of participants in the postoperative incision infection group and ulcer infection group will receive routine dressing change treatment, namely cleaning with chlorhexidine disinfectant (100 ml chlorhexidine disinfectant for every 10 cm2 wound area), drainage, bandaging. The wounds of participants in the fat liquefaction group will be receive conventional treatment, namely negative pressure sputum aspiration.
The researchers will determine the dressing change time according to the size of the patient's wound and the number of secretions, starting every day or every other day, and waiting for the incision to be fresh or less secretions at an interval of 2-3 days. Receives: Other: Routine nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The trends in wound healing rate
Wound healing rate=Number of healing cases/total cases ×100%
Measured: 1 day up to 21 days
Secondary outcomes (4)
The number of participants with wound effusion
Observe whether there is fluid, pus and other exudation on the wound and the number of days when the effusion disappeared will be recorded.
Measured: The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment
The number of participants who tested positive for the etiology of wound exudates or extracts
Check whether there is bacterial infection and infected strains on the wound.
Measured: The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.
Wound pain score
Wound pain will be measured on the Visual Analogue Scale with a minimum score of 0 and a maximum score of 10 on the VAS, 0 indicating no pain at all, 10 indicating severe pain that is unbearable, and a higher score indicating more severe pain.
Measured: The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.
The number of adverse event
In this trial, any adverse medical event occurring within 30 days after the subject's signing of the informed consent to the final dose, regardless of whether there is a causal relationship with the test drug, is considered to be an adverse event. Adverse events and descriptions of all associated symptoms, such as time of occurrence, severity, duration, action taken, final outcome and outcome, will be recorded.
Measured: These indicators will be collected at 1, 7, 14, and 21 days after starting treatment, and at 1 week and 1 month after ending treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start20 Jul 2023 (estimated)
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Chang, PhD, Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924867
- Sponsor's protocol ID
- XJYFY-2021ZD03
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mirhaj M, Labbaf S, Tavakoli M, Seifalian A. An Overview on the Recent Advances in the Treatment of Infected Wounds: Antibacterial Wound Dressings. Macromol Biosci. 2022 Jul;22(7):e2200014. doi: 10.1002/mabi.202200014. Epub 2022 Apr 28.
PubMed 35421269Cheng B, Jiang Y, Fu X, Hao D, Liu H, Liu Y, Huang Z, Tan Q, Wang L, Hu D, Yang Y, Han C, Cheng Z, Ran X, Li Y. Epidemiological characteristics and clinical analyses of chronic cutaneous wounds of inpatients in China: Prevention and control. Wound Repair Regen. 2020 Sep;28(5):623-630. doi: 10.1111/wrr.12825. Epub 2020 Jun 25.
PubMed 32585756Kadam S, Shai S, Shahane A, Kaushik KS. Recent Advances in Non-Conventional Antimicrobial Approaches for Chronic Wound Biofilms: Have We Found the 'Chink in the Armor'? Biomedicines. 2019 Apr 30;7(2):35. doi: 10.3390/biomedicines7020035.
PubMed 31052335Sen CK. Human Wound and Its Burden: Updated 2020 Compendium of Estimates. Adv Wound Care (New Rochelle). 2021 May;10(5):281-292. doi: 10.1089/wound.2021.0026.
PubMed 33733885Bernhardt T, Semmler ML, Schafer M, Bekeschus S, Emmert S, Boeckmann L. Plasma Medicine: Applications of Cold Atmospheric Pressure Plasma in Dermatology. Oxid Med Cell Longev. 2019 Sep 3;2019:3873928. doi: 10.1155/2019/3873928. eCollection 2019.
PubMed 31565150Brany D, Dvorska D, Halasova E, Skovierova H. Cold Atmospheric Plasma: A Powerful Tool for Modern Medicine. Int J Mol Sci. 2020 Apr 22;21(8):2932. doi: 10.3390/ijms21082932.
PubMed 32331263Smolkova B, Frtus A, Uzhytchak M, Lunova M, Kubinova S, Dejneka A, Lunov O. Critical Analysis of Non-Thermal Plasma-Driven Modulation of Immune Cells from Clinical Perspective. Int J Mol Sci. 2020 Aug 28;21(17):6226. doi: 10.3390/ijms21176226.
PubMed 32872159Rezaei F, Vanraes P, Nikiforov A, Morent R, De Geyter N. Applications of Plasma-Liquid Systems: A Review. Materials (Basel). 2019 Aug 27;12(17):2751. doi: 10.3390/ma12172751.
PubMed 31461960Zhai S, Xu M, Li Q, Guo K, Chen H, Kong MG, Xia Y. Successful Treatment of Vitiligo with Cold Atmospheric Plasma-Activated Hydrogel. J Invest Dermatol. 2021 Nov;141(11):2710-2719.e6. doi: 10.1016/j.jid.2021.04.019. Epub 2021 May 21.
PubMed 34029575Tanaka H, Bekeschus S, Yan D, Hori M, Keidar M, Laroussi M. Plasma-Treated Solutions (PTS) in Cancer Therapy. Cancers (Basel). 2021 Apr 6;13(7):1737. doi: 10.3390/cancers13071737.
PubMed 33917469Lee HR, Kang SU, Kim HJ, Ji EJ, Yun JH, Kim S, Jang JY, Shin YS, Kim CH. Liquid plasma as a treatment for cutaneous wound healing through regulation of redox metabolism. Cell Death Dis. 2023 Feb 13;14(2):119. doi: 10.1038/s41419-023-05610-9.
PubMed 36781835Xu D, Wang S, Li B, Qi M, Feng R, Li Q, Zhang H, Chen H, Kong MG. Effects of Plasma-Activated Water on Skin Wound Healing in Mice. Microorganisms. 2020 Jul 21;8(7):1091. doi: 10.3390/microorganisms8071091.
PubMed 32708347Kim S, Kim CH. Applications of Plasma-Activated Liquid in the Medical Field. Biomedicines. 2021 Nov 16;9(11):1700. doi: 10.3390/biomedicines9111700.
PubMed 34829929Jang Y, Bok J, Ahn DK, Kim CK, Kang JS. Human Trial for the Effect of Plasma-Activated Water Spray on Vaginal Cleaning in Patients with Bacterial Vaginosis. Med Sci (Basel). 2022 Jun 18;10(2):33. doi: 10.3390/medsci10020033.
PubMed 35736353Liu Z, Dumville JC, Norman G, Westby MJ, Blazeby J, McFarlane E, Welton NJ, O'Connor L, Cawthorne J, George RP, Crosbie EJ, Rithalia AD, Cheng HY. Intraoperative interventions for preventing surgical site infection: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2018 Feb 6;2(2):CD012653. doi: 10.1002/14651858.CD012653.pub2.
PubMed 29406579
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Plasma Activated Saline in Wound Treatment
- ClinicalTrials.gov ID
- NCT05924867
- Acronym / sponsor ID
- XJYFY-2021ZD03
- Conditions
- Wound, Wound Infection, Wound Heal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, open-label, randomized, parallel controlled clinical trial. The purpose of this study is to understand the application value of plasma-activated normal saline in the treatment of different types of wounds. The main questions it aims to answer are:
- What is the effect of plasma activated normal saline in promoting wound healing of different types?
- What is the safety of plasma activated normal saline in the treatment of wound surface? Subjects will be randomly divided into the intervention group and the control group. The intervention group will receive wound treatment with plasma activated normal saline, and the control group will receive routine dressing change treatment.
Detailed description
As the population ages and antibiotic resistance increases, the chance of co-infection of various types of wounds increases greatly, resulting in prolonged wounds healing and eventually leading to bloodstream infections caused by germs, which can develop into life-threatening sepsis in severe cases. Plasma active saline is rich in reactive oxygen groups (ROS) and reactive nitrogen groups (RNS). It has good anti-inflammatory effect and is a potential new material to control wound infection and promote wound healing. Therefore, the purpose of this study was to apply plasma-activated water to different types of wounds and evaluate the effect of plasma-activated water on promoting healing of different types of wounds. And security issues in the application process.
This study is a prospective, open label, randomized, parallel controlled trial. This study is expected to include 162 subjects, including 46 patients with postoperative incision infection, 34 patients with postoperative incision fat liquefaction, and 82 patients with cutaneous infectious ulcer. The participants will be randomly divided into intervention group and control group by grouping randomized method. The intervention group will be treated with plasma activated water flushing and wet compress, and the control group will be treated with routine dressing change. The investigators will collect participants' wound conditions, blood, microbiological tests and other relevant indicators during treatment and follow-up.
To analyze the efficacy and safety of plasma-activated saline in the treatment of different wounds, the investigators will use independent sample T-test and K-M methods to compare the efficacy of the two groups, use descriptive analysis to represent the type and frequency of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: plasma activated salineThe wounds of participants in the postoperative incision infection group and ulcer infection group will be given plasma activated saline irrigation (100 ml plasma activated saline for every 10 cm2 wound), drainage, and wet compress. The wounds of participants in the fat liquefaction group will be uniformly rinsed with plasma saline for 5-10 min to clean the incision, then drained and suction with negative pressure. The researchers will determine the dressing change time according to the size of the patient's wound and the number of secretions, starting every day or every other day, and waiting for the incision to be fresh or less secretions at an interval of 2-3 days. |
| Control group | Active comparator | Other: Routine nursingThe wounds of participants in the postoperative incision infection group and ulcer infection group will receive routine dressing change treatment, namely cleaning with chlorhexidine disinfectant (100 ml chlorhexidine disinfectant for every 10 cm2 wound area), drainage, bandaging. The wounds of participants in the fat liquefaction group will be receive conventional treatment, namely negative pressure sputum aspiration. The researchers will determine the dressing change time according to the size of the patient's wound and the number of secretions, starting every day or every other day, and waiting for the incision to be fresh or less secretions at an interval of 2-3 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma activated salineThe plasma activated normal saline used in the intervention was prepared by a self-made machine, and the safety of the plasma activated water produced by the machine has passed the national quality inspection. | Other | Intervention group |
| Routine nursingFor postoperative incision infection group and infected ulcer group, conventional dressing change treatment was given, namely chlorhexidine disinfectant washing, drainage and bandaging; For the fat liquefaction group, conventional treatment was given, namely negative pressure suction. | Other | Control group |
Primary outcome
The trends in wound healing rate
Time frame: 1 day up to 21 days
Wound healing rate=Number of healing cases/total cases ×100%
4 secondary outcomes
The number of participants with wound effusion
Time frame: The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment
The number of participants who tested positive for the etiology of wound exudates or extracts
Time frame: The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.
Wound pain score
Time frame: The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.
The number of adverse event
Time frame: These indicators will be collected at 1, 7, 14, and 21 days after starting treatment, and at 1 week and 1 month after ending treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 35421269Mirhaj M, Labbaf S, Tavakoli M, Seifalian A. An Overview on the Recent Advances in the Treatment of Infected Wounds: Antibacterial Wound Dressings. Macromol Biosci. 2022 Jul;22(7):e2200014. doi: 10.1002/mabi.202200014. Epub 2022 Apr 28.
- Background: PubMed 32585756Cheng B, Jiang Y, Fu X, Hao D, Liu H, Liu Y, Huang Z, Tan Q, Wang L, Hu D, Yang Y, Han C, Cheng Z, Ran X, Li Y. Epidemiological characteristics and clinical analyses of chronic cutaneous wounds of inpatients in China: Prevention and control. Wound Repair Regen. 2020 Sep;28(5):623-630. doi: 10.1111/wrr.12825. Epub 2020 Jun 25.
- Background: PubMed 31052335Kadam S, Shai S, Shahane A, Kaushik KS. Recent Advances in Non-Conventional Antimicrobial Approaches for Chronic Wound Biofilms: Have We Found the 'Chink in the Armor'? Biomedicines. 2019 Apr 30;7(2):35. doi: 10.3390/biomedicines7020035.
- Background: PubMed 33733885Sen CK. Human Wound and Its Burden: Updated 2020 Compendium of Estimates. Adv Wound Care (New Rochelle). 2021 May;10(5):281-292. doi: 10.1089/wound.2021.0026.
- Background: PubMed 31565150Bernhardt T, Semmler ML, Schafer M, Bekeschus S, Emmert S, Boeckmann L. Plasma Medicine: Applications of Cold Atmospheric Pressure Plasma in Dermatology. Oxid Med Cell Longev. 2019 Sep 3;2019:3873928. doi: 10.1155/2019/3873928. eCollection 2019.
- Background: PubMed 32331263Brany D, Dvorska D, Halasova E, Skovierova H. Cold Atmospheric Plasma: A Powerful Tool for Modern Medicine. Int J Mol Sci. 2020 Apr 22;21(8):2932. doi: 10.3390/ijms21082932.
- Background: PubMed 32872159Smolkova B, Frtus A, Uzhytchak M, Lunova M, Kubinova S, Dejneka A, Lunov O. Critical Analysis of Non-Thermal Plasma-Driven Modulation of Immune Cells from Clinical Perspective. Int J Mol Sci. 2020 Aug 28;21(17):6226. doi: 10.3390/ijms21176226.
- Background: PubMed 31461960Rezaei F, Vanraes P, Nikiforov A, Morent R, De Geyter N. Applications of Plasma-Liquid Systems: A Review. Materials (Basel). 2019 Aug 27;12(17):2751. doi: 10.3390/ma12172751.
- Background: PubMed 34029575Zhai S, Xu M, Li Q, Guo K, Chen H, Kong MG, Xia Y. Successful Treatment of Vitiligo with Cold Atmospheric Plasma-Activated Hydrogel. J Invest Dermatol. 2021 Nov;141(11):2710-2719.e6. doi: 10.1016/j.jid.2021.04.019. Epub 2021 May 21.
- Background: PubMed 33917469Tanaka H, Bekeschus S, Yan D, Hori M, Keidar M, Laroussi M. Plasma-Treated Solutions (PTS) in Cancer Therapy. Cancers (Basel). 2021 Apr 6;13(7):1737. doi: 10.3390/cancers13071737.
- Background: PubMed 36781835Lee HR, Kang SU, Kim HJ, Ji EJ, Yun JH, Kim S, Jang JY, Shin YS, Kim CH. Liquid plasma as a treatment for cutaneous wound healing through regulation of redox metabolism. Cell Death Dis. 2023 Feb 13;14(2):119. doi: 10.1038/s41419-023-05610-9.
- Background: PubMed 32708347Xu D, Wang S, Li B, Qi M, Feng R, Li Q, Zhang H, Chen H, Kong MG. Effects of Plasma-Activated Water on Skin Wound Healing in Mice. Microorganisms. 2020 Jul 21;8(7):1091. doi: 10.3390/microorganisms8071091.
- Individual participant dataSharing planned: Undecided
Related trials for Wound
Recruiting
Restorative Early Sleep Treatment After the Emergency Department
Insomnia, Nightmares Associated With Trauma and Stress
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
RecruitingPhase 1
A Study of Amicidin-β Topical Solution for Patients With a Contaminated or Infected Surgical or Traumatic Wound or Cutaneous Abscess
Surgical Wound Infection, Traumatic Wound Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Chang, PhD study director
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plasma activated saline and Routine nursing in people with Wound and Wound Infection, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miao Runchen, PhD (0086-18229097849, miaozao91@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The trends in wound healing rate (time frame: 1 day up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05924867, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023; AzTrials last refreshed its copy on 4 Nov 2026.