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A prospective randomised controlled clinical trial of the safety and efficacy of a portable negative pressure drainage therapy product for clinical use

A prospective randomised controlled clinical trial of the safety and efficacy of a portable negative pressure drainage therapy product for clinical use

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095807
Enrollment
Unknown
Registered
2025-01-13
Start date
2025-01-15
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Surgical Incision

Interventions

Portable Negative Pressure Therapy Group:Treatment with portable negative pressure drainage
Conventional treatment group:Traditional Dressing Treatment

Sponsors

Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18~75 years old, male or female; 2. The length of the surgical suture incorpois is less than or equal to 30cm, and the first-stage suture can be completed; 3. The wound is located in the continuous flat part of the limbs and trunk; 4. Good patient compliance; 5. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe preoperative wound infection; 2. History of diabetes mellitus; 3. Patients with abnormal coagulation function; 4. Patients with cardiac insufficiency, hepatic insufficiency, renal insufficiency or hematologic comorbidities; 5. Patients with severe hypoproteinemia and severe systemic infection; 6. Patients with scar constitution or scar constitution tendency; 7. Patients with mental illness or severe mental illness; 8. Those who are allergic to dressing materials; 9. Other patients who are considered by the investigator to be unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Whether incisional complications occur;

Secondary

MeasureTime frame
Indicators for evaluating healing;Portability indicators;Economic indicators;Safety indicators;

Countries

China

Contacts

Public ContactChuanan Shen

The Fourth Medical Center of Chinese PLA General Hospital

shenchuanan@301hospital.com.cn+86 139 1059 5595

Outcome results

None listed

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