Incisional Negative Pressure Therapy to Prevent Animal Induced Wound Infection

Not Applicable

Not yet recruiting

• Conditions: Wound Infection; Injury Caused by Animal Bites

• 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

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Study Start: 2024-08-20
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Delayed healing of wounds (DHW)	2-4 weeks	Wound healing time is longer than 14 days.
Wound reprocessing (WR)	≤4 weeks	Including wound dehiscence, hematoma, seroma and other situation needed to switch treatments.
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