Negative Pressure Wound Therapy in Groin Dissection
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
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2014
CompletedFirst Posted
Study publicly available on registry
April 6, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedApril 6, 2015
April 1, 2015
4 years
December 19, 2014
April 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to wound healing
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 Outcomes (5)
Wound infection 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)
From date of surgery up to one year post-operatively.
Need for further surgical interventions to achieve wound healing
From date of surgery until wound is healed, up to 20 weeks after surgery.
Scar appearance (POSAS)
From date of surgery up to one year post-operatively.
Patient reported outcomes (qualitative interview)
From date of surgery to six months post-operatively.
Study Arms (2)
PICO™
ACTIVE COMPARATORUse of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days.
Conventional wound care
NO INTERVENTIONUsual wound dressings will be used as comparison group.
Interventions
Negative pressure wound therapy device for closed surgical wounds.
Eligibility Criteria
You may qualify if:
- Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin
You may not qualify if:
- inability to give informed consent for participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ulster Hospital
Belfast, Northern Ireland, BT16 1RH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christopher Hill, MB
South Eastern Health & Social Care Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Academic Clinical Lecturer
Study Record Dates
First Submitted
December 19, 2014
First Posted
April 6, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
April 6, 2015
Record last verified: 2015-04