Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-04-22 @ 11:31 AM
Study NCT ID:
NCT02408835
Status:
UNKNOWN
Last Update Posted:
2015-04-06
First Post:
2014-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Negative Pressure Wound Therapy in Groin Dissection
Sponsor:
South Eastern Health and Social Care Trust
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: