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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02408835
Other study ID # NPWT/14/1.0
Secondary ID
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


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
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