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New treatment option for Skin Transplantation
Official title Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study
ClinicalTrials.gov ID: NCT07040683
What this study is testing
- What it's testing
- The goal of this clinical trial is to compare the effect of negative pressure wound therapy (NPWT) versus traditional dressings on the incidence of transplant infection in adult patients undergoing split-thickness skin grafting (STSG) to the lower leg following excision of a skin tumour. The main questions it aims to answer are: Does NPWT reduce the incidence of transplant infection within three months after STSG?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults aged 18 years or older
- Undergoing excision of a skin tumour on the lower leg with planned coverage using split-thickness skin grafting (STSG)
- Eligible procedures include primary excision, secondary excision, or extended excision performed at the same site as a previous tumour surgery
- Ability to provide written informed consent
- Ability to comply with postoperative instructions and follow-up visits
You likely can't join if
- Inability to follow postoperative instructions due to cognitive impairment, dementia, or significant language barriers
- Inability to provide informed consent
- Severe systemic illness, including:
- Ongoing sepsis
- Advanced heart failure
- End-stage renal or liver disease
See the full eligibility criteria
- Adults aged 18 years or older
- Undergoing excision of a skin tumour on the lower leg with planned coverage using split-thickness skin grafting (STSG)
- Eligible procedures include primary excision, secondary excision, or extended excision performed at the same site as a previous tumour surgery
- Ability to provide written informed consent
- Ability to comply with postoperative instructions and follow-up visits
- Inability to follow postoperative instructions due to cognitive impairment, dementia, or significant language barriers
- Inability to provide informed consent
- Severe systemic illness, including:
- Ongoing sepsis
- Advanced heart failure
- End-stage renal or liver disease
- Active chemotherapy within the previous three months
- Ongoing treatment with immunosuppressive medications, including:
- Systemic corticosteroids (e.g., prednisone \>20 mg/day or equivalent)
- Calcineurin inhibitors (e.g., cyclosporine, tacrolimus)
- Antimetabolites (e.g., methotrexate, azathioprine, mycophenolate mofetil)
- mTOR inhibitors (e.g., sirolimus, everolimus)
- Biologic therapies (e.g., rituximab, TNF inhibitors, IL-6 inhibitors, IL-1, IL-17, IL-23 inhibitors)
- Targeted molecular therapies (e.g., JAK inhibitors such as tofacitinib, baricitinib)
- Other immunosuppressive drugs
- Previous radiation therapy to the surgical site
- Presence of severe skin disease affecting the planned graft recipient site (e.g., advanced psoriasis)
The study team makes the final eligibility decision.
Where it's taking place
- Malmö, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Malmö, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.