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Not yet recruiting NCT06558942

Incisional Negative Pressure Therapy to Prevent Animal Induced Wound Infection

No phase Interventional Injury Caused by Animal Bites Wound Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: incisional negative pressure wound technology.
Who it may be relevant to
Registry conditions: Injury Caused by Animal Bites, Wound Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • Device incisional negative pressure wound technology
    Negative pressure device used directly on closed or sutured incisions

Primary outcome measures

  • Wound infection (WI) [Time frame: <4 weeks]
Secondary outcome measures (3)
  • Delayed healing of wounds (DHW) [Time frame: 2-4 weeks]
  • Wound reprocessing (WR) [Time frame: ≤4 weeks]
  • other wound complication [Time frame: ≤4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Emergency Department of Peking University First Hospital — Beijing

Publications

  • Chen F, Liu Q, Jiang Q, Shi J, Luba TR, Hundera AD, Fang P, Cao S, Lu Z. Risk of human exposure to animal bites in China: a clinic-based cross-sectional study. Ann N Y Acad Sci. 2019 Sep;1452(1):78-87. doi: 10.1111/nyas.14202. Epub 2019 Aug 9. PMID 31397929
  • Philipsen TE, Molderez C, Gys T. Cat and dog bites. What to do? Guidelines for the treatment of cat and dog bites in humans. Acta Chir Belg. 2006 Nov-Dec;106(6):692-5. doi: 10.1080/00015458.2006.11679983. PMID 17290697
  • Fernandez Vecilla D, Aspichueta Vivanco C, Ugalde Zarraga E, Diaz de Tuesta Del Arco JL. Wound infection caused by Pasteurella canis and Neisseria animaloris after a dog bite. Rev Esp Quimioter. 2023 Dec;36(6):635-637. doi: 10.37201/req/035.2023. Epub 2023 Sep 29. No abstract available. PMID 37772341
  • Eichenauer F, Kim S, Hakimi M, Eisenschenk A, Weber S. [Infections of the Hand after Bite Injuries]. Handchir Mikrochir Plast Chir. 2021 Jun;53(3):237-244. doi: 10.1055/a-1382-8093. Epub 2021 Jun 16. German. PMID 34134156
  • Zangari A, Cerigioni E, Nino F, Guidi R, Gulia C, Piergentili R, Ilari M, Mazzoni N, Cobellis G. Dog bite injuries in a tertiary care children's hospital: A seven-year review. Pediatr Int. 2021 May;63(5):575-580. doi: 10.1111/ped.14484. Epub 2021 Apr 20. PMID 32979010
  • Miller C. The History of Negative Pressure Wound Therapy (NPWT): From "Lip Service" to the Modern Vacuum System. J Am Coll Clin Wound Spec. 2013 Nov 28;4(3):61-2. doi: 10.1016/j.jccw.2013.11.002. eCollection 2012 Sep. PMID 26236637
  • Fleischmann W, Strecker W, Bombelli M, Kinzl L. [Vacuum sealing as treatment of soft tissue damage in open fractures]. Unfallchirurg. 1993 Sep;96(9):488-92. German. PMID 8235687
  • Morykwas MJ, David LR, Schneider AM, Whang C, Jennings DA, Canty C, Parker D, White WL, Argenta LC. Use of subatmospheric pressure to prevent progression of partial-thickness burns in a swine model. J Burn Care Rehabil. 1999 Jan-Feb;20(1 Pt 1):15-21. doi: 10.1097/00004630-199901001-00003. PMID 9934631

Identifiers

NCT: NCT06558942 · 2024SF59

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗