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

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Status and phase: Unknown; Phase 3

Conditions: Infected Surgical Wound

Treatments: Device: PTNiA; Device: PTN; Device: PTNiB

Study type: Interventional

Funder types: Other

Identifiers

NCT02500875

AISLeC-004

Details and patient eligibility

About

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%.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

PTNiA

Experimental group

Description:

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).

Treatment:

Device: PTNiA

PTNiB

Experimental group

Description:

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).

Treatment:

Device: PTNiB

PTN

Active Comparator group

Description:

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).

Treatment:

Device: PTN