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 ]

Determination of wound healing


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