Negative Pressure Wound Therapy in Groin Dissection

Sponsor

South Eastern Health and Social Care Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT02408835

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Metastasis Secondary Malignant Neoplasm of Lymph Node Non-healing Surgical Wound (Disorder) Skin Neoplasms	Device: PICO™	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2019

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PICO™ Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days.	Device: PICO™ Negative pressure wound therapy device for closed surgical wounds. Other Names: PICO™, Smith & Nephew Healthcare, UK
No Intervention: Conventional wound care Usual wound dressings will be used as comparison group.

Arm

Intervention/Treatment

Active Comparator: PICO™

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

Device: PICO™

Negative pressure wound therapy device for closed surgical wounds.

Other Names:

PICO™, Smith & Nephew Healthcare, UK

No Intervention: Conventional wound care

Usual wound dressings will be used as comparison group.

Outcome Measures

Primary Outcome Measures

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

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)
Lymphoedema (Limb volume measurements) [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 [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.