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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICO™ | Active Comparator | Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days. |
|
| Conventional wound care | No Intervention | Usual wound dressings will be used as comparison group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICO™ | Device | Negative pressure wound therapy device for closed surgical wounds. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra E McAllister, MD | Contact | 02890484511 | s.mcallister@qub.ac.uk | |
| Christopher Hill, MB | Contact | 02890484511 |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Hill, MB | South Eastern Health & Social Care Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ulster Hospital | Belfast | Northern Ireland | BT16 1RH | United Kingdom |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008207 | Lymphatic Metastasis |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |