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

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%.

Study Overview

• Status: Unknown
• Conditions: Infected Surgical Wound
• Intervention / Treatment: Device: PTNiA; Device: PTNiB; Device: PTN

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico Sant'Orsola Malpighi
    • Contact: Angela Peghetti; Email: angela.peghetti@aosp.bo.it
    • Contact: Paolo Chiari; Email: paolo.chiari@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTNiA; Topical negative pressure therapy with instillation of saline solution (6 times daily). During the instillation of saline solution, aspiration is stopped for 10-15 minutes and subsequently the device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg. The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days).	Device: PTNiA
Experimental: PTNiB; Topical negative pressure therapy with instillation of Amukine Med 0,05% (6 times daily). During the instillation of Amukine Med 0,05%, aspiration is stopped for 10-15 minutes and subsequently the device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg. The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days).	Device: PTNiB
Active Comparator: PTN; Topical negative pressure therapy (without instillation). The device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg. The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days).	Device: PTN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of clinical infection (according NHSN 2014)	frequency of wound without clinical infection	1 month
Absence of clinical infection	number of days to absence clinical infection	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment days	number of days to wounds treatment	1 month
Wound closure	number of days to wounds closure	1 month
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
Patient's pain (Numeric Rating Scale (NRS)	assessment with Numeric Rating Scale (NRS)	1 month

Collaborators and Investigators

• Sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee
• Investigators: Principal Investigator: Paolo Chiari, Policlinico Sant'Orsola Malpighi Bologna

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: May 24, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Sodium Hypochlorite; Negative-Pressure Wound Therapy; Topical Negative Pressure Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Wounds and Injuries; Surgical Wound; Surgical Wound Infection
• Other Study ID Numbers: AISLeC-004