Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation

Infected Surgical Wound Clinical Trial

— PTN-INSTILL  

Official title:

Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02500875
• Other study ID #: AISLeC-004
• Status: Recruiting
• Phase: Phase 3
• First received: May 24, 2015
• Last updated: July 15, 2015
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: May 2015
• Source: Associazione Infermieristica per lo studio delle Lesioni Cutanee
• Contact: Paolo Chiari
• Email: paolo.chiari[@]aosp.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN therapy without instillation in the treatment of infected surgical wounds. Investigators mean to verify differences of effectiveness between the different types of instilled substances, normal saline versus Amukine Med 0.5%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with infected surgical wounds.

• Patient age greater than or equal to 18 years.

• Patients who have given informed consent to the enrollment in the trial and to the processing of personal data.

Exclusion Criteria:

• Patients unable of consent.

• Patients affected by serious medical conditions that, according to the investigator's opinion, represent a contraindication to the study participation.

• Patients affected by wounds with exposition of blood vessels, sutures, organs or nerves and open wounds in mediastinum or abdomen.

• Patients with malignancy at the wound.

• Patients with untreated osteomyelitis.

• Patients with enteric and unexplored fistulas.

• Patients with necrotic tissue and eschar.

• Immunocompromised patients or in treatment with corticosteroids.

• Suspected or known allergic diathesis to the product of medication.

• Patients with coagulation disease.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infected Surgical Wound
• Surgical Wound Infection

Intervention

Device:
• PTNiA

• PTNiB

• PTN

Locations

Country	Name	City	State
Italy	Policlinico Sant'Orsola Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Associazione Infermieristica per lo studio delle Lesioni Cutanee

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of clinical infection (according NHSN 2014)	frequency of wound without clinical infection	1 month	No
Primary	Absence of clinical infection	number of days to absence clinical infection	1 month	No
Secondary	Treatment days	number of days to wounds treatment	1 month	No
Secondary	Wound closure	number of days to wounds closure	1 month	No
Secondary	Patient's discharge	number of days to patient's discharge	participants will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	Patient's pain (Numeric Rating Scale (NRS)	assessment with Numeric Rating Scale (NRS)	1 month	No