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Negative Pressure Wound Therapy in Groin Dissection

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PICO™
Sponsored by
South Eastern Health and Social Care Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring negative pressure wound therapy, lymphadenectomy, wound healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Ulster Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

PICO™

Conventional wound care

Arm Description

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

Usual wound dressings will be used as comparison group.

Outcomes

Primary Outcome Measures

Time to wound healing
Determination of wound healing

Secondary Outcome Measures

Wound infection As defined by Comprehensive Complication Index (CCI)
As defined by Comprehensive Complication Index (CCI)
Lymphoedema (Limb volume measurements)
Limb volume measurements at 3, 6, 9 and 12 months
Need for further surgical interventions to achieve wound healing
Scar appearance (POSAS)
POSAS at 3,6, 9 and 12 months
Patient reported outcomes (qualitative interview)
Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery.

Full Information

First Posted
December 19, 2014
Last Updated
April 3, 2015
Sponsor
South Eastern Health and Social Care Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02408835
Brief Title
Negative Pressure Wound Therapy in Groin Dissection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Eastern Health and Social Care Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis, Secondary Malignant Neoplasm of Lymph Node, Non-healing Surgical Wound (Disorder), Skin Neoplasms
Keywords
negative pressure wound therapy, lymphadenectomy, wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PICO™
Arm Type
Active Comparator
Arm Description
Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days.
Arm Title
Conventional wound care
Arm Type
No Intervention
Arm Description
Usual wound dressings will be used as comparison group.
Intervention Type
Device
Intervention Name(s)
PICO™
Other Intervention Name(s)
PICO™, Smith & Nephew Healthcare, UK
Intervention Description
Negative pressure wound therapy device for closed surgical wounds.
Primary Outcome Measure Information:
Title
Time to wound healing
Description
Determination of 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
Secondary Outcome Measure Information:
Title
Wound infection As defined by Comprehensive Complication Index (CCI)
Description
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.
Title
Lymphoedema (Limb volume measurements)
Description
Limb volume measurements at 3, 6, 9 and 12 months
Time Frame
From date of surgery up to one year post-operatively.
Title
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.
Title
Scar appearance (POSAS)
Description
POSAS at 3,6, 9 and 12 months
Time Frame
From date of surgery up to one year post-operatively.
Title
Patient reported outcomes (qualitative interview)
Description
Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery.
Time Frame
From date of surgery to six months post-operatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin Exclusion Criteria: inability to give informed consent for participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra E McAllister, MD
Phone
02890484511
Email
s.mcallister@qub.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Hill, MB
Phone
02890484511
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hill, MB
Organizational Affiliation
South Eastern Health & Social Care Trust
Official's Role
Study Chair
Facility Information:
Facility Name
The Ulster Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT16 1RH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra E McAllister, MD
Phone
+442890484511
Email
s.mcallister@qub.ac.uk
First Name & Middle Initial & Last Name & Degree
Christopher Hill, MB

12. IPD Sharing Statement

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Negative Pressure Wound Therapy in Groin Dissection

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