Clinical trial NCT02408835: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasm Metastasis
Secondary Malignant Neoplasm of Lymph Node
Non-healing Surgical Wound (Disorder)
Skin Neoplasms
Keywords: negative pressure wound therapy
lymphadenectomy
wound healing
Lead sponsor: South Eastern Health and Social Care Trust
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to wound healing
timeFrame: 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:
measure: Wound infection As defined by Comprehensive Complication Index (CCI)
timeFrame: From date of surgery until wound is healed (epithelial integrity restored at surgical site), up to 20 weeks after surgery.
measure: Lymphoedema (Limb volume measurements)
timeFrame: From date of surgery up to one year post-operatively.
measure: Need for further surgical interventions to achieve wound healing
timeFrame: From date of surgery until wound is healed, up to 20 weeks after surgery.
measure: Scar appearance (POSAS)
timeFrame: From date of surgery up to one year post-operatively.
measure: Patient reported outcomes (qualitative interview)
timeFrame: From date of surgery to six months post-operatively.
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: The Ulster Hospital
state: Northern Ireland
Study officials:
affiliation: South Eastern Health & Social Care Trust
name: Christopher Hill, MB
role: STUDY_CHAIR
References: