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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Time to wound healing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin
Exclusion Criteria
- •inability to give informed consent for participation
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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.)
- 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.)
- Lymphoedema (Limb volume measurements)(From date of surgery up to one year post-operatively.)
Investigators
Sandra McAllister
Academic Clinical Lecturer
South Eastern Health and Social Care Trust