Negative Pressure Wound Therapy in Groin Dissection

April 3, 2015 updated by: Sandra McAllister, South Eastern Health and Social Care Trust

A Randomised Controlled Trial Comparing PICO™ Single Use Negative Pressure Wound Therapy System (Smith & Nephew Healthcare Limited, UK) to Conventional Wound Care Following Inguinal Lymphadenectomy for Metastatic Cutaneous Malignancy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT16 1RH
        • The Ulster Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

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

Exclusion Criteria:

  • inability to give informed consent for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PICO™
Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days.
Device: PICO™
Negative pressure wound therapy device for closed surgical wounds.
Other Names:
  • PICO™, Smith & Nephew Healthcare, UK
No Intervention: Conventional wound care
Usual wound dressings will be used as comparison group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to wound healing
Time Frame: From date of surgery until epithelial integrity is restored at the surgical site. Assessed at least weekly until wound is healed, up to 20 weeks after surgery
Determination of wound healing
From date of surgery until epithelial integrity is restored at the surgical site. Assessed at least weekly until wound is healed, up to 20 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound infection As defined by Comprehensive Complication Index (CCI)
Time Frame: From date of surgery until wound is healed (epithelial integrity restored at surgical site), up to 20 weeks after surgery.
As defined by Comprehensive Complication Index (CCI)
From date of surgery until wound is healed (epithelial integrity restored at surgical site), up to 20 weeks after surgery.
Lymphoedema (Limb volume measurements)
Time Frame: From date of surgery up to one year post-operatively.
Limb volume measurements at 3, 6, 9 and 12 months
From date of surgery up to one year post-operatively.
Need for further surgical interventions to achieve wound healing
Time Frame: From date of surgery until wound is healed, up to 20 weeks after surgery.
From date of surgery until wound is healed, up to 20 weeks after surgery.
Scar appearance (POSAS)
Time Frame: From date of surgery up to one year post-operatively.
POSAS at 3,6, 9 and 12 months
From date of surgery up to one year post-operatively.
Patient reported outcomes (qualitative interview)
Time Frame: From date of surgery to six months post-operatively.
Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery.
From date of surgery to six months post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Eastern Health and Social Care Trust

Investigators

  • Study Chair: Christopher Hill, MB, South Eastern Health & Social Care Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

April 3, 2015

First Posted (Estimate)

April 6, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 3, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPWT/14/1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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