No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
242 (estimated)
Sponsor
Region Skane · Other
Who this trial is looking for
This trial is looking for adults who need skin graft surgery on their lower leg after removing a skin tumor. Participants will receive either special negative pressure dressings or traditional dressings after their surgery and will attend follow-up visits.
Are You a Good Fit for This Trial?
Must not be takingSystemic corticosteroidsCalcineurin inhibitorsAntimetabolitesmTOR inhibitorsBiologic therapiesTargeted molecular therapies
Rules you outSevere skin disease affecting the graft site
You may be able to join if
I am 18 years old or older.
I need a skin tumor removed from my lower leg and will have a skin graft.
I can give written consent.
I can follow postoperative instructions and attend follow-up visits.
You may not be able to join if
I cannot follow postoperative instructions due to cognitive issues.
I cannot provide informed consent.
I have severe ongoing infections.
I have advanced heart failure.
I have end-stage kidney or liver disease.
I have had chemotherapy in the last three months.
I am taking immunosuppressive medications.
I have had radiation therapy on the surgical site.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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?
Does NPWT improve secondary outcomes such as graft take, reduce reoperations, complications, and resource use?
Researchers will compare patients treated with NPWT to patients treated with traditional dressings to see if NPWT results in lower infection rates and better clinical outcomes.
Participants will:
Undergo excision of a skin tumour on the lower leg followed by STSG.
Be randomized to receive either NPWT or traditional dressings applied over the graft.
Follow a structured postoperative care and mobilisation schedule.
Attend follow-up visits at day 5 and day 14 postoperatively and be monitored through medical record review up to three months after surgery.
Trial Locations
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Eligibility Criteria
Inclusion 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 previ…
Inclusion 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
Exclusion Criteria:
* 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)
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