Negative Pressure Wound Therapy in Groin Dissection

Not Applicable

• Conditions: Non-healing Surgical Wound (Disorder); Neoplasm Metastasis; Skin Neoplasms; Secondary Malignant Neoplasm of Lymph Node
• Interventions: Device: PICO™

• Registration Number: NCT02408835
• Lead Sponsor: South Eastern Health and Social Care Trust

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 Timeline

• Study First Submitted: 2014-12-19
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-03
• Last Update Submitted: 2015-04-03
• Study First Posted: 2015-04-06
• Last Update Posted: 2015-04-06
• Study Start: 2015-07
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin

Exclusion Criteria

• inability to give informed consent for participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICO™	PICO™	Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days.

Primary Outcome Measures

Name	Time	Method
Time to wound healing	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 Outcome Measures

Name	Time	Method
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.	As defined by Comprehensive Complication Index (CCI)
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.	POSAS at 3,6, 9 and 12 months
Patient reported outcomes (qualitative interview)	From date of surgery to six months post-operatively.	Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery.
Lymphoedema (Limb volume measurements)	From date of surgery up to one year post-operatively.	Limb volume measurements at 3, 6, 9 and 12 months

Trial Locations

Locations (1)

The Ulster Hospital; 🇬🇧 Belfast, Northern Ireland, United Kingdom