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Efficacy and Safety of a Handheld Plasma Sterilization Device in ICU Patients With Pressure Injuries and Incontinence-Associated Dermatitis: A Randomized, Single-Blind, Single-Center Trial

Efficacy and Safety of a Handheld Plasma Sterilization Device in ICU Patients With Pressure Injuries and Incontinence-Associated Dermatitis: A Randomized, Single-Blind, Single-Center Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122743
Enrollment
Unknown
Registered
2026-04-17
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU pressure injuries and incontinence-associated dermatitis

Interventions

Control group?:1. Reduce local pressure: Assist patients in turning over regularly to avoid prolonged stay in the same position, protect bony prominences, and use air mattresses to protect the skin
2.Avoid local irritation: Clean the skin promptly and keep the skin and the bed surface clean and dry
3. Ensure good nutrition: Strengthen nutrition to prevent anemia and hypoproteinemia
4.Wound management, prevention of infection: Disinfect the pressure injury areas of patients to prevent wound infection
clean and dress the patient's wounds
use the Pressure Injury Healing Assessment Form (PUSH) to assess the dynamic changes of pressure injuries
for stage II pressure injuries, if the wound surface is clean, apply hydrocolloid dressings
if there is exudation, use foam dressings
protect small blisters to allow them to absorb on their own
for large blisters, use sterile syringes to extract the fluid inside the blister and retain the epidermis, and choose dressings based on the condition of the wound surface
for stage III and above pressure injuries, perform wound debridement and treatment, disinfect the skin around the wound with iodophor solution, clean the wound with normal saline solution, and use sil
if there is severe infection or large exudation, use iodophor gauze packing and dressings to cover the wound.
intervention group?:Based on the routine care measures for patients with pressure injuries, a handheld plasma sterilization device was used to irradiate the affected areas of pressure injuries. Each t
Control group?:1.Handling incontinence: Identify the causes of incontinence. For frequent bow

Sponsors

The First Affiliated Hospital of USTC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Study?: 1. Age = 18 years; 2. Stayed in the ICU for = 24 hours and the expected hospital stay exceeds 14 days; 3. The condition permits full-body examination of the skin; 4. Meets the diagnostic criteria for pressure injury at stage 2 or above; 5. The patient or his/her family members have given informed consent and voluntarily participated in this study. Study?: 1. Age = 18 years; 2. Stayed in the ICU for = 24 hours, and the expected hospital stay exceeds 7 days; 3. The condition permits a full-body examination of the skin; 4. Meets the diagnostic criteria for pressure ulcers; 5. The patient or their family members have given informed consent and voluntarily participated in this study.

Exclusion criteria

Exclusion criteria: Study?: 1. Critically ill patients in emergency treatment; 2. Those whose vital signs may be affected by strict immobilization and body position changes; 3. Patients in the terminal stage; 4. Those who are currently participating in or have participated in other research projects within the past 30 days. Study?: 1. Critically ill patients in emergency treatment; 2. Those whose vital signs will be affected by strict immobilization and body position changes; 3. Patients in the terminal stage; 4. Those who already have pressure injuries or incontinence dermatitis upon admission; 5. Those with intestinal infections, intestinal pre-stimulation syndrome, post-anal or rectal surgery, or rectal prolapse and other intestinal diseases; 6. Those with injuries to the perineal area (all soft tissues below the pelvic diaphragm); 7. Those who are currently participating in or have participated in other research projects within the past 30 days.

Design outcomes

Primary

MeasureTime frame
Pressure ulcer healing score (PUSH score) (Study ?);IADS Score (Study ?);

Secondary

MeasureTime frame
Pressure Injury Status Score (PSST) (Study ?);Bacterial count of the wound (Study ?);Area of Pressure Ulcer (Study ?);Effective duration(Study ?);The healing rate and healing time of incontinence-associated dermatitis(Study ?);Efficiency and Effective Time (Study ?);Incontinence-related dermatitis grading (Study ?);Types and quantities of bacteria on the skin surface (Study ?);

Countries

China

Contacts

Public ContactShoujun Zhu

The First Affiliated Hospital of USTC

1377021730@qq.com+86 189 1963 6592

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026