Negative Pressure Wound Therapy in Groin Dissection

Neoplasm Metastasis Clinical Trial

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 Lymphadenectomy for Metastatic Cutaneous Malignancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02408835
• Other study ID #: NPWT/14/1.0
• Status: Not yet recruiting
• Phase: N/A
• First received: December 19, 2014
• Last updated: April 3, 2015
• Start date: July 2015
• Est. completion date: July 2019

Study information

• Verified date: April 2015
• Source: South Eastern Health and Social Care Trust
• Contact: Sandra E McAllister, MD
• Phone: 02890484511
• Email: s.mcallister[@]qub.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• PICO™
Negative pressure wound therapy device for closed surgical wounds.

Locations

Country	Name	City	State
United Kingdom	The Ulster Hospital	Belfast	Northern Ireland

Sponsors (1)

Lead Sponsor	Collaborator
South Eastern Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to wound healing	Determination of 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	No
Secondary	Wound infection As defined by Comprehensive Complication Index (CCI)	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.	No
Secondary	Lymphoedema (Limb volume measurements)	Limb volume measurements at 3, 6, 9 and 12 months	From date of surgery up to one year post-operatively.	No
Secondary	Need for further surgical interventions to achieve wound healing		From date of surgery until wound is healed, up to 20 weeks after surgery.	No
Secondary	Scar appearance (POSAS)	POSAS at 3,6, 9 and 12 months	From date of surgery up to one year post-operatively.	No
Secondary	Patient reported outcomes (qualitative interview)	Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery.	From date of surgery to six months post-operatively.	No