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Incisional Negative Pressure Therapy to Prevent Animal Induced Wound Infection

Not Applicable
Not yet recruiting
Conditions
Wound Infection
Injury Caused by Animal Bites
Interventions
Device: incisional negative pressure wound technology
Registration Number
NCT06558942
Lead Sponsor
Peking University First Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
iNPWT groupincisional negative pressure wound technologyThe clinical data of 60 patients who met the inclusion and exclusion criteria were collected prospectively, including: gender, age, smoking, body mass index (BMI), hypertension, diabetes, aspirin and other antiplatelet drugs, anticoagulants, injured animals (dogs or cats), wound parameters (including wound site, wound length, wound depth, and time of subsequent diagnosis). Rinse the patient's wound with a weak alkaline disinfectant for 15 minutes, thoroughly clean the wound, and then suture it in one stage. Place the device of incisional negative pressure wound therapy (iNPWT) and evaluate the wound quality for 2-3 days. If necessary, extend the use of the iNPWT device. All patients received prophylactic use of antibiotics within one week.
Primary Outcome Measures
NameTimeMethod
Wound infection (WI)<4 weeks

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

Secondary Outcome Measures
NameTimeMethod
Wound reprocessing (WR)≤4 weeks

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

Delayed healing of wounds (DHW)2-4 weeks

Wound healing time is longer than 14 days.

other wound complication≤4 weeks

redness and rash of skin around the wound.

Trial Locations

Locations (1)

Emergency Department of Peking University First Hospital

🇨🇳

Beijing, Beijing, China

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