Negative Pressure Wound Therapy in Groin Dissection

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: PICO™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin Exclusion Criteria: inability to give informed consent for participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Lymphoedema (Limb volume measurements) | Limb volume measurements at 3, 6, 9 and 12 months | From date of surgery up to one year post-operatively. | 
| 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) | POSAS at 3,6, 9 and 12 months | From date of surgery up to one year post-operatively. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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negative pressure wound therapy, lymphadenectomy, wound healing