Plasma Activated Saline in Wound Treatment

NCT05924867 | Unknown

• 1 other identifier: XJYFY-2021ZD03
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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. 1.What is the effect of plasma activated normal saline in promoting wound healing of different types?
2. 2.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.

Conditions

Wound; Wound Infection; Wound Heal

Outcome Measures

Primary Outcomes (1)

• The trends in wound healing rate

  Wound healing rate=Number of healing cases/total cases ×100%

  1 day up to 21 days

Secondary Outcomes (4)

• The number of participants with wound effusion

  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

  The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.

• Wound pain score

  The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.

• The number of adverse event

  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.

Study Arms (2)

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.

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.

Other: Routine nursing

Interventions

plasma activated saline OTHER

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.

Intervention group

Routine nursing OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

Location

Related Publications (19)

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• Jang 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.

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• Leren L, Johansen EA, Eide H, Sorum Falk R, Ljosa TM. Prevalence and factors associated with ulcer-related pain in persons with chronic leg ulcers-an explorative study. J Clin Nurs. 2021 Sep;30(17-18):2732-2741. doi: 10.1111/jocn.15787. Epub 2021 May 5.

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• Seidel D, Diedrich S, Herrle F, Thielemann H, Marusch F, Schirren R, Talaulicar R, Gehrig T, Lehwald-Tywuschik N, Glanemann M, Bunse J, Huttemann M, Braumann C, Heizmann O, Miserez M, Kronert T, Gretschel S, Lefering R. Negative Pressure Wound Therapy vs Conventional Wound Treatment in Subcutaneous Abdominal Wound Healing Impairment: The SAWHI Randomized Clinical Trial. JAMA Surg. 2020 Jun 1;155(6):469-478. doi: 10.1001/jamasurg.2020.0414.

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MeSH Terms

Conditions

Wounds and Injuries; Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Liu Chang, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Miao Runchen, PhD

CONTACT

0086-18229097849; miaozao91@163.com

Wang Saiyu, Master

CONTACT

0086-15670590777; wsy321567@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 29, 2023
• Study Start: July 20, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-06

Locations

CN (1)