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Novel airbag pressurized securement device to secure peripheral intravenous catheter in skin barrier dysfunction patients: A feasibility randomised controlled trial

Clinical study of a new airbag compression fixation material in patients with skin barrier dysfunction: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107772
Enrollment
Unknown
Registered
2025-08-18
Start date
2025-03-25
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

None

Interventions

Experimental group (securement device group):Patients assigned to fixation devices use traditional indwelling needle fixation patches and new airbag compression fixation materials
Control group:Patients assigned to the control group were fixed with a patch using a conventional short peripheral venous catheter

Sponsors

The First Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Including but not limited to patients with dermatological diseases such as drug rash, chronic eczema, psoriasis, contact dermatitis, etc., or skin barrier dysfunction due to prolonged hospitalization, post-surgery, etc., manifested by dermatological changes such as skin dryness, oozing, eczema, dermatitis, etc.; 2. The retention site is the forearm, the back of the hand, and long-term intravenous infusion treatment is required (>=4 days); 3. The age of the patient is 18 years old or older; and 4. Those who signed the informed consent form and voluntarily participated in this study.

Exclusion criteria

Exclusion criteria: 1. patients with a history of allergy to nonwoven or balloon materials; 2. patients with infection, ulceration, necrosis, or severe edema at the puncture site; and 3. patients who are unable to cooperate with the study interventions (e.g., patients with impaired consciousness or psychiatric disorders).

Design outcomes

Primary

MeasureTime frame
Fixation effect (Rate of indwelling needle patch displacement/dislodgement);Fixation effect (Duration of indwelling needle fixation);Fixed effect (changing times of indwelling needle film);Cost analysis;Comfort;

Countries

China

Contacts

Public ContactLi Li

The First Hospital of Shanxi Medical University

lili3213@163.com+86 136 3344 3213

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026