Injury Caused by Animal BitesNCT06558942
Incisional Negative Pressure Therapy to Prevent Animal Induced Wound Infection
A study testing incisional negative pressure wound technology in people with Injury Caused by Animal Bites and Wound Infection, run by Peking University First Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury Caused by Animal Bites, Wound Infection
- What is being tested?
- incisional negative pressure wound technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Emergency Department of Peking University First Hospital
Beijing, Beijing Municipality, 100000
About this study
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
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
- Being tested
- incisional negative pressure wound technology
- Keywords
- Animal bite injury, Incision negative pressure treatment technology, Wound infection rate
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incisional negative pressure wound technologyDevice
Also called iNPWT
Negative pressure device used directly on closed or sutured incisions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: incisional negative pressure wound technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection (WI)
The local skin of the wound appears red, swollen, hot, and painful, with or without systemic hyperthermia
Measured: <4 weeks
Secondary outcomes (3)
Delayed healing of wounds (DHW)
Wound healing time is longer than 14 days.
Measured: 2-4 weeks
Wound reprocessing (WR)
Including wound dehiscence, hematoma, seroma and other situation needed to switch treatments.
Measured: ≤4 weeks
other wound complication
redness and rash of skin around the wound.
Measured: ≤4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Injury Caused by Animal BitesStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shi Jiping, Master, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558942
- Sponsor's protocol ID
- 2024SF59
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31397929Philipsen 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.
PubMed 17290697Fernandez 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.
PubMed 37772341Eichenauer 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.
PubMed 34134156Zangari 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.
PubMed 32979010Miller 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.
PubMed 26236637Fleischmann 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.
PubMed 8235687Morykwas 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.
PubMed 9934631Stannard 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.
PubMed 16766975Glaser 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.
PubMed 25876166De 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.
PubMed 35994306Dohmen 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.
PubMed 24754343Gabriele 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.
PubMed 33755942Newman 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.
PubMed 30545653Salmenkyla 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.
PubMed 35907824
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06558942
- Acronym / sponsor ID
- 2024SF59
- Conditions
- Injury Caused by Animal Bites, Wound Infection
- Keywords
- Animal bite injury, Incision negative pressure treatment technology, Wound infection rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iNPWT group | Experimental | Device: incisional negative pressure wound technologyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| incisional negative pressure wound technologyAlso: iNPWTNegative pressure device used directly on closed or sutured incisions | Device | iNPWT group |
Primary outcome
Wound infection (WI)
Time frame: <4 weeks
The local skin of the wound appears red, swollen, hot, and painful, with or without systemic hyperthermia
3 secondary outcomes
Delayed healing of wounds (DHW)
Time frame: 2-4 weeks
Wound reprocessing (WR)
Time frame: ≤4 weeks
other wound complication
Time frame: ≤4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Results publication: PubMed 31397929Chen 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.
- Results publication: PubMed 17290697Philipsen 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.
- Results publication: PubMed 37772341Fernandez 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.
- Results publication: PubMed 34134156Eichenauer 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.
- Results publication: PubMed 32979010Zangari 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.
- Results publication: PubMed 26236637Miller 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.
- Results publication: PubMed 8235687Fleischmann 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.
- Results publication: PubMed 9934631Morykwas 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.
- Results publication: PubMed 16766975Stannard 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.
- Results publication: PubMed 25876166Glaser 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.
- Results publication: PubMed 35994306De 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.
- Results publication: PubMed 24754343Dohmen 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi Jiping, Master principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing incisional negative pressure wound technology in people with Injury Caused by Animal Bites and Wound Infection, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shi Jiping, Master (18801238951, earthsjp@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound infection (WI) (time frame: <4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06558942, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.