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

NCT02500875 | Unknown Phase 3 DMC

• 1 other identifier: AISLeC-004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Infected Surgical Wound

Keywords

Negative-Pressure Wound Therapy; Topical Negative Pressure Therapy; Sodium Hypochlorite

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Treatment days

  1 month

• Wound closure

  1 month

• 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)

  1 month

Study Arms (3)

PTNiA

EXPERIMENTAL

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

PTNiB

EXPERIMENTAL

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

PTN

ACTIVE COMPARATOR

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

Interventions

PTNiA DEVICE

PTNiA

PTNiB DEVICE

PTNiB

PTN DEVICE

PTN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Associazione Infermieristica per lo studio delle Lesioni Cutanee: lead

Study Sites (1)

Policlinico Sant'Orsola Malpighi

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Chiari

  Policlinico Sant'Orsola Malpighi Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Chiari

CONTACT

paolo.chiari@aosp.it

Angela Peghetti

CONTACT

angela.peghetti@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 24, 2015
• First Posted: July 17, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: July 17, 2015

Record last verified: 2015-05

Locations

IT (1)