NCT02408835

Negative Pressure Wound Therapy in Groin Dissection

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: South Eastern Health and Social Care Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasm Metastasis
• Secondary Malignant Neoplasm of Lymph Node
• Non-healing Surgical Wound (Disorder)
• Skin Neoplasms

Interventions

Type	Name	Description
DEVICE	PICO™	Negative pressure wound therapy device for closed surgical wounds.

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2015-04-06
• Last updated: 2015-04-06

Locations

1 site across 1 country: United Kingdom