Incisional Negative Pressure Therapy to Prevent Animal Induced Wound Infection

NCT06558942 | Not Yet Recruiting

• 1 other identifier: 2024SF59
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Injury Caused by Animal Bites; Wound Infection

Keywords

Animal bite injury; Incision negative pressure treatment technology; Wound infection rate

Outcome Measures

Primary Outcomes (1)

• Wound infection (WI)

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

  <4 weeks

Secondary Outcomes (3)

• Delayed healing of wounds (DHW)

  2-4 weeks

• Wound reprocessing (WR)

  ≤4 weeks

• other wound complication

  ≤4 weeks

Study Arms (1)

iNPWT group

EXPERIMENTAL

The 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.

Device: incisional negative pressure wound technology

Interventions

incisional negative pressure wound technology DEVICE

Negative pressure device used directly on closed or sutured incisions

Also known as: iNPWT

iNPWT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Emergency Department of Peking University First Hospital

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (17)

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  PMID: 26236637 RESULT

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  PMID: 16766975 RESULT

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  PMID: 35994306 RESULT

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  PMID: 35907824 RESULT

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  PMID: 30975040 RESULT

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  PMID: 37538540 RESULT

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Shi Jiping, Master

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shi Jiping, Master

CONTACT

18801238951; earthsjp@126.com

Liu Si, doctor

CONTACT

15701064937; DocLeo@PKU.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 19, 2024
• Study Start: August 20, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)