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NCT Number: NCT06558942

Incisional Negative Pressure Therapy to Prevent Animal Induced Wound Infection

Animal injuries are a significant public health issue, with the most common being bites or scratches from cats and dogs. Every year, over 40 million people in China are bitten or scratched by cats and dogs, which can lead to wound infections and even systemic complications, with infection rates ranging from 10% to 80%. However, there is still no better way to reduce wound infection rates in current clinical studies and guidelines.

Incisional negative pressure wound therapy (iNPWT) is a new wound treatment technology developed in recent years. It creates a negative pressure environment on sutured or closed wounds, helps to fix the edges of the incision together, reduce lateral tension on the wound, stimulate blood perfusion at the edge of the wound, remove fluid from the wound, and act as an external pollution barrier. INPWT has been widely used for postoperative wound healing in surgery, but there is currently a lack of effective clinical trials on its ability to prevent wound infections caused by animal injuries and promote wound healing.

This study aims to apply iNPWT technology to the wounds of patients with rabies grade III exposure who underwent primary suturing, and compare it with wounds covered with ordinary gauze after previous primary suturing to determine whether it can help reduce postoperative incision infection rates and promote wound healing. This will provide high-quality clinical evidence for the widespread use of wound management in rabies grade III exposure patients in the future.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department of Peking University First Hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Limds injuries caused by animals, first or second animal injury to Grade III exposed patients, with deep wounds reaching the fat layer, tendons, and even penetrating injuries.
  • Patients with wounds>2cm and severe injuries that even require surgical treatment.

Exclusion criteria

  • Missing or incomplete follow-up data within 30 days.
  • Patients who have been infected with wounds or have been injured for more than 8 hours before seeking medical attention.
  • Acupuncture like wound (<2mm).
  • Patients with whole skin detachment.

Treatment and study plan

incisional negative pressure wound technology

Device

Negative pressure device used directly on closed or sutured incisions

Other names: iNPWT

Primary outcomes

  1. Wound infection (WI)

    Time frame: <4 weeks

    The local skin of the wound appears red, swollen, hot, and painful, with or without systemic hyperthermia

Secondary outcomes

  1. Delayed healing of wounds (DHW)

    Time frame: 2-4 weeks

    Wound healing time is longer than 14 days.

  2. Wound reprocessing (WR)

    Time frame: ≤4 weeks

    Including wound dehiscence, hematoma, seroma and other situation needed to switch treatments.

  3. other wound complication

    Time frame: ≤4 weeks

    redness and rash of skin around the wound.

Study contacts

Contact information is provided by the study sponsor or research team.

Liu Si, doctor

CONTACT

[email protected]

15701064937

Shi Jiping, Master

CONTACT

[email protected]

18801238951

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

A Study on the Application of Incisional Negative Pressure Therapy in Reducing the Risk of Infection in Animal Induced Injury Patients With Primary Wound Closure

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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