An interventional study of PICO™ in Neoplasm Metastasis, Secondary Malignant Neoplasm of Lymph Node and Non-healing Surgical Wound (Disorder), sponsored by South Eastern Health and Social Care Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-06.
Sponsored by South Eastern Health and Social Care Trust · Not applicable, Interventional, and Treatment
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.
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's planned enrollment of 22 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →South Eastern Health and Social Care Trust is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days.
Device: PICO™
Usual wound dressings will be used as comparison group.
Negative pressure wound therapy device for closed surgical wounds.
Also known as: PICO™, Smith & Nephew Healthcare, UK
Time to wound healing
Determination of wound healing
Time frame: 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
Wound infection As defined by Comprehensive Complication Index (CCI)
As defined by Comprehensive Complication Index (CCI)
Time frame: 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
Time frame: From date of surgery up to one year post-operatively.
Need for further surgical interventions to achieve wound healing
Time frame: 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
Time frame: 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.
Time frame: From date of surgery to six months post-operatively.
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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South Eastern Health and Social Care Trust