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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Negative pressure wound therapy device for closed surgical wounds.
The Ulster Hospital
Belfast, Northern Ireland, United Kingdom
Time to wound healing
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
Wound infection As defined by Comprehensive Complication Index (CCI)
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.
Lymphoedema (Limb volume measurements)
Limb volume measurements at 3, 6, 9 and 12 months
Time frame: From date of surgery up to one year post-operatively.
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.
Scar appearance (POSAS)
POSAS at 3,6, 9 and 12 months
Time frame: From date of surgery up to one year post-operatively.
Patient reported outcomes (qualitative interview)
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.
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