Clinical trial NCT06558942: Incisional Negative Pressure Therapy to Prevent Animal Induced Wound Infection
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Injury Caused by Animal Bites
Wound Infection
Keywords: Animal bite injury
Incision negative pressure treatment technology
Wound infection rate
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Wound infection (WI)
timeFrame: <4 weeks
Secondary outcomes:
measure: Delayed healing of wounds (DHW)
timeFrame: 2-4 weeks
measure: Wound reprocessing (WR)
timeFrame: ≤4 weeks
measure: other wound complication
timeFrame: ≤4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Emergency Department of Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Shi Jiping, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Stannard JP, Robinson JT, Anderson ER, McGwin G Jr, Volgas DA, Alonso JE. Negative pressure wound therapy to treat hematomas and surgical incisions following high-energy trauma. J Trauma. 2006 Jun;60(6):1301-6. doi: 10.1097/01.ta.0000195996.73186.2e.
citation: Glaser DA, Farnsworth CL, Varley ES, Nunn TA, Sayad-Shah M, Breisch EA, Yaszay B. Negative pressure therapy for closed spine incisions: a pilot study. Wounds. 2012 Nov;24(11):308-16.
citation: De Leon JC, Karia RA. Incisional and Surrounding Periarticular Soft Tissue Management With Negative Pressure Therapy. J Orthop Trauma. 2022 Sep 1;36(Suppl 4):S26-S30. doi: 10.1097/BOT.0000000000002429.
citation: Dohmen PM, Misfeld M, Borger MA, Mohr FW. Closed incision management with negative pressure wound therapy. Expert Rev Med Devices. 2014 Jul;11(4):395-402. doi: 10.1586/17434440.2014.911081. Epub 2014 Apr 22.
citation: Gabriele L, Gariffo G, Grossi S, Ipponi E, Capanna R, Andrean L. Closed Incisional Negative Pressure Wound Therapy (ciNPWT) in Oncological Orthopedic Surgery: Preliminary Report. Surg Technol Int. 2021 May 20;38:451-454. doi: 10.52198/21.STI.38.OS1429.
citation: Newman JM, Siqueira MBP, Klika AK, Molloy RM, Barsoum WK, Higuera CA. Use of Closed Incisional Negative Pressure Wound Therapy After Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection: A Prospective, Randomized Clinical Trial. J Arthroplasty. 2019 Mar;34(3):554-559.e1. doi: 10.1016/j.arth.2018.11.017. Epub 2018 Nov 17.
citation: Salmenkyla T, Kilpivaara K, Ohtonen P, Rautio T, Makarainen E. Case control study investigating the clinical utility of NPWT in the perineal region following abdominoperineal resection for rectal adenocarcinoma: a single center study. BMC Surg. 2022 Jul 30;22(1):296. doi: 10.1186/s12893-022-01746-1.
citation: Mehdorn M, Niebisch S, Scheuermann U, Gockel I, Jansen-Winkeln B. Incisional negative pressure wound therapy does not reduce surgical site infections in abdominal midline incisions: a case control study. Acta Chir Belg. 2020 Aug;120(4):250-256. doi: 10.1080/00015458.2019.1599180. Epub 2019 Apr 12.
citation: Groenen H, Jalalzadeh H, Buis DR, Dreissen YEM, Goosen JHM, Griekspoor M, Harmsen WJ, IJpma FFA, van der Laan MJ, Schaad RR, Segers P, van der Zwet WC, de Jonge SW, Orsini RG, Eskes AM, Wolfhagen N, Boermeester MA. Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysis. EClinicalMedicine. 2023 Jul 24;62:102105. doi: 10.1016/j.eclinm.2023.102105. eCollection 2023 Aug.