Clinical Trial: Negative Pressure Wound Therapy in Groin Dissection
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
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 Lymphade
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 Summary:
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.
Sponsor: South Eastern Health and Social Care Trust
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Wound infection 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. ]As defined by Comprehensive Complication Index (CCI)
- Lymphoedema (Limb volume measurements) [ Time Frame: From date of surgery up to one year post-operatively. ]Limb volume measurements at 3, 6, 9 and 12 months
- 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) [ Time Frame: From date of surgery up to one year post-operatively. ]POSAS at 3,6, 9 and 12 months
- Patient reported outcomes (qualitative interview) [ Time Frame: From date of surgery to six months post-operatively. ]Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery.
Original Secondary Outcome: Same as current
Information By: South Eastern Health and Social Care Trust
Dates:
Date Received: December 19, 2014
Date Started: July 2015
Date Completion: July 2019
Last Updated: April 3, 2015
Last Verified: April 2015