Negative Pressure Wound Therapy in Groin Dissection

NCT ID: NCT02408835

Last Updated: 2015-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PICO™

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

Group Type ACTIVE_COMPARATOR

PICO™

Intervention Type DEVICE

Negative pressure wound therapy device for closed surgical wounds.

Conventional wound care

Usual wound dressings will be used as comparison group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PICO™

Negative pressure wound therapy device for closed surgical wounds.

Intervention Type DEVICE

Other Intervention Names

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PICO™, Smith & Nephew Healthcare, UK

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* inability to give informed consent for participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Eastern Health and Social Care Trust

OTHER

Sponsor Role lead

Responsible Party

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Sandra McAllister

Academic Clinical Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Hill, MB

Role: STUDY_CHAIR

South Eastern Health & Social Care Trust

Locations

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The Ulster Hospital

Belfast, Northern Ireland, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Sandra E McAllister, MD

Role: CONTACT

02890484511

Christopher Hill, MB

Role: CONTACT

02890484511

Facility Contacts

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Sandra E McAllister, MD

Role: primary

+442890484511

Other Identifiers

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NPWT/14/1.0

Identifier Type: -

Identifier Source: org_study_id

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