Incisional Negative Pressure Therapy to Prevent Animal Induced Wound Infection

August 15, 2024 updated by: Peking University First Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Emergency Department of Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iNPWT group
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
Negative pressure device used directly on closed or sutured incisions
Other Names:
  • iNPWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound infection (WI)
Time Frame: <4 weeks
The local skin of the wound appears red, swollen, hot, and painful, with or without systemic hyperthermia
<4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed healing of wounds (DHW)
Time Frame: 2-4 weeks
Wound healing time is longer than 14 days.
2-4 weeks
Wound reprocessing (WR)
Time Frame: ≤4 weeks
Including wound dehiscence, hematoma, seroma and other situation needed to switch treatments.
≤4 weeks
other wound complication
Time Frame: ≤4 weeks
redness and rash of skin around the wound.
≤4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Shi Jiping, Master, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

August 11, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024SF59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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