Negative Pressure Wound Therapy in Groin Dissection

South Eastern Health and Social Care Trust

Status: Unknown

Conditions: Non-healing Surgical Wound (Disorder); Skin Neoplasms; Secondary Malignant Neoplasm of Lymph Node; Neoplasm Metastasis

Treatments: Device: PICO™

Study type: Interventional

Funder types: Other

Identifiers

NCT02408835

NPWT/14/1.0

Details and patient eligibility

About

This study investigates the use of a negative pressure wound therapy device (PICO™, Smith & Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.

Full description

Patients may develop inguinal lymph node metastases from a variety of cutaneous neoplasms. A number of factors conspire to cause a high rate of wound breakdown and other complications in this patient group. Reported rates of wound healing complications vary in the literature, but tend to affect > 40% of patients.

A new negative pressure wound therapy device is recommended for use in clean, closed surgical wounds (PICO™ system, Smith & Nephew Healthcare, UK). Patients will be randomised to receive either PICO™ system for up to seven days, or conventional dressings, and then assessed for wound healing and other outcome measures.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin

Exclusion criteria

• inability to give informed consent for participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

PICO™

Active Comparator group

Description:

Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days.

Treatment:

Device: PICO™

Conventional wound care

No Intervention group

Description:

Usual wound dressings will be used as comparison group.