Skin TransplantationLEGSNCT07040683
Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split-thickness Skin Grafts After Lower Leg Skin Tumour Excision
A study testing Negative Pressure Wound Therapy (NPWT) and Traditional Dressing in people with Skin Transplantation and Skin Grafting, run by Region Skane at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Transplantation, Skin Grafting, Split Thickness Skin Graft
- What is being tested?
- Negative Pressure Wound Therapy (NPWT) and Traditional Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2025to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.
Malmö, 20501
Pooya Rajabaleyan, MD, PhD, +4640331000, Pooya.rajabaleyan@skane.se
Mia Stiernman, MD, PhD, +4640331000, mia.stiernman@med.lu.se
About this study
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 graft infection within 2 weeks after STSG?
Read more
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.
Read the detailed description
Split-thickness skin grafting (STSG) to the lower leg is a common surgical procedure performed after excision of skin tumours, particularly when primary closure is not feasible. Although the technique is well established, postoperative infections and graft-related complications remain a clinical challenge, especially in lower leg wounds, which are prone to oedema and mechanical stress.
Negative pressure wound therapy (NPWT) has been introduced as an alternative to traditional dressings for skin grafts. NPWT applies controlled suction to the wound environment, promoting fluid removal, enhancing blood flow, and potentially improving graft adherence and reducing infection risk. However, current evidence for NPWT in lower leg grafting is limited and inconclusive.
The Legs Trial is a multicentre, randomised controlled trial designed to compare NPWT with traditional dressings in adult patients undergoing STSG to the lower leg after tumour excision. The primary objective is to assess whether NPWT reduces the incidence of transplant infections within three months. Secondary outcomes include graft loss, reoperations, postoperative complications, hospital stay, and healthcare resource use.
Patients will be randomised to receive either NPWT or traditional dressing at the time of surgery. All patients will follow a structured postoperative mobilisation protocol and attend follow-up visits for outcome assessment.
The trial aims to generate high-quality evidence to inform best practices in postoperative management of lower leg skin grafts and optimise patient outcomes.
- Conditions
- Skin Transplantation, Skin Grafting, Split Thickness Skin Graft, Negative-Pressure Wound Therapy, Postoperative Complications, Surgical Wound Infection
- Being tested
- Negative Pressure Wound Therapy (NPWT), Traditional Dressing
- Keywords
- Skin Transplantation, Skin Grafting, Split Thickness, Negative-Pressure Wound Therapy, Postoperative Complications, Surgical Wound Infection, Lower Extremity, Wound Healing, Bandages, Leg, Skin Neoplasms, Skin Cancer
- Medical subject headings
- Postoperative Complications, Surgical Wound Infection, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound Therapy (NPWT)Device
Also called VAC Therapy, Negative Pressure Dressing
Negative pressure wound therapy (NPWT) applied over the split-thickness skin graft on the lower leg after tumour excision. A protective silicone interface layer will be used, with continuous negative pressure of -125 mmHg applied until postoperative day 5, unless earlier change is clinically indicated.
Traditional DressingOther
Traditional dressing applied over the split-thickness skin graft on the lower leg after tumour excision. The dressing consists of one or more layers of foam dressing applied on top, which may or may not be fixed with sutures according to surgeon preference, and an elastic bandage applied over the foam to provide gentle, even compression and immobilisation of the graft. The dressing will remain undisturbed until postoperative day 5 unless earlier change is clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | Experimental | Participants in this arm will receive negative pressure wound therapy (NPWT) applied over the split-thickness skin graft after excision of a skin tumour on the lower leg. NPWT will be applied according to manufacturer instructions, using a protective interface layer and continuous negative pressure of -125 mmHg until postoperative day 5. Receives: Device: Negative Pressure Wound Therapy (NPWT) |
| Traditional Dressings | Active comparator | Participants in this arm will receive traditional dressings applied over the split-thickness skin graft after excision of a skin tumour on the lower leg. The dressing will include a protective silicone interface layer and foam dressing with gentle compression, left undisturbed until postoperative day 5. Receives: Other: Traditional Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of transplant infection within 2 weeks after index surgery
Graft infection defined as clinical infection of the skin graft diagnosed by a physician or confirmed by microbiological culture, occurring within 2 weeks after initial tumor excision and split-thickness skin grafting to the lower leg.
Measured: From date of index surgery until 2 weeks postoperatively.
Secondary outcomes (7)
Graft loss percentage graft take at 2 weeks
Graft loss percentage graft at 2 weeks after index surgery.
Measured: From date of index surgery until 2 weeks postoperatively.
Reoperation within 2 weeks after index surgery
Proportion of participants requiring reoperation related to the graft site within 2 weeks after index surgery.
Measured: From date of index surgery until 2 weeks postoperatively.
Bleeding within 2 weeks after index surgery
Incidence of clinically significant bleeding at the graft site requiring medical intervention within 2 weeks after index surgery.
Measured: From date of index surgery until 2 weeks postoperatively.
Complications within 3 months after index surgery
All systemic and surgical complications occurring within 3 months after the index surgery will be recorded and graded according to the Clavien-Dindo classification.
Measured: From date of index surgery until 3 months postoperatively.
Mortality within 3 months weeks after index surgery
All-cause mortality within 3 months after index surgery.
Measured: From date of index surgery until 3 months postoperatively.
Length of hospital stay
Number of inpatient days related to the graft procedure.
Measured: From date of index surgery until 3 months postoperatively.
Healthcare resource use within 3 months
Healthcare resource use based on costs of NPWT, traditional bandages, number of outpatient visits, use of antibiotics, and total days of hospitalisation within 3 months after index surgery.
Measured: From date of index surgery until 3 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Nov 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either negative pressure wound therapy (NPWT) or traditional dressings after split-thickness skin grafting to the lower leg. Each participant will remain in their assigned treatment group for the duration of the study, with outcomes assessed at follow-up visits and by medical record review up to three months postoperatively.
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pooya Rajabaleyan, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040683
- Sponsor's protocol ID
- 2024-05592-01
- Acronym
- LEGS
- Status last verified
- Aug 2026
- First submitted
- 11 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split-thickness Skin Grafts After Lower Leg Skin Tumour Excision
- ClinicalTrials.gov ID
- NCT07040683
- Acronym / sponsor ID
- LEGS / 2024-05592-01
- Conditions
- Skin Transplantation, Skin Grafting, Split Thickness Skin Graft, Negative-Pressure Wound Therapy, Postoperative Complications, Surgical Wound Infection
- Keywords
- Skin Transplantation, Skin Grafting, Split Thickness, Negative-Pressure Wound Therapy, Postoperative Complications, Surgical Wound Infection, Lower Extremity, Wound Healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 graft infection within 2 weeks 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.
Detailed description
Split-thickness skin grafting (STSG) to the lower leg is a common surgical procedure performed after excision of skin tumours, particularly when primary closure is not feasible. Although the technique is well established, postoperative infections and graft-related complications remain a clinical challenge, especially in lower leg wounds, which are prone to oedema and mechanical stress.
Negative pressure wound therapy (NPWT) has been introduced as an alternative to traditional dressings for skin grafts. NPWT applies controlled suction to the wound environment, promoting fluid removal, enhancing blood flow, and potentially improving graft adherence and reducing infection risk. However, current evidence for NPWT in lower leg grafting is limited and inconclusive.
The Legs Trial is a multicentre, randomised controlled trial designed to compare NPWT with traditional dressings in adult patients undergoing STSG to the lower leg after tumour excision. The primary objective is to assess whether NPWT reduces the incidence of transplant infections within three months. Secondary outcomes include graft loss, reoperations, postoperative complications, hospital stay, and healthcare resource use.
Patients will be randomised to receive either NPWT or traditional dressing at the time of surgery. All patients will follow a structured postoperative mobilisation protocol and attend follow-up visits for outcome assessment.
The trial aims to generate high-quality evidence to inform best practices in postoperative management of lower leg skin grafts and optimise patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either negative pressure wound therapy (NPWT) or traditional dressings after split-thickness skin grafting to the lower leg. Each participant will remain in their assigned treatment group for the duration of the study, with outcomes assessed at follow-up visits and by medical record review up to three months postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | Experimental | Device: Negative Pressure Wound Therapy (NPWT)Participants in this arm will receive negative pressure wound therapy (NPWT) applied over the split-thickness skin graft after excision of a skin tumour on the lower leg. NPWT will be applied according to manufacturer instructions, using a protective interface layer and continuous negative pressure of -125 mmHg until postoperative day 5. |
| Traditional Dressings | Active comparator | Other: Traditional DressingParticipants in this arm will receive traditional dressings applied over the split-thickness skin graft after excision of a skin tumour on the lower leg. The dressing will include a protective silicone interface layer and foam dressing with gentle compression, left undisturbed until postoperative day 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound Therapy (NPWT)Also: VAC Therapy, Negative Pressure DressingNegative pressure wound therapy (NPWT) applied over the split-thickness skin graft on the lower leg after tumour excision. A protective silicone interface layer will be used, with continuous negative pressure of -125 mmHg applied until postoperative day 5, unless earlier change is clinically indicated. | Device | Negative Pressure Wound Therapy (NPWT) |
| Traditional DressingTraditional dressing applied over the split-thickness skin graft on the lower leg after tumour excision. The dressing consists of one or more layers of foam dressing applied on top, which may or may not be fixed with sutures according to surgeon preference, and an elastic bandage applied over the foam to provide gentle, even compression and immobilisation of the graft. The dressing will remain undisturbed until postoperative day 5 unless earlier change is clinically indicated. | Other | Traditional Dressings |
Primary outcome
Incidence of transplant infection within 2 weeks after index surgery
Time frame: From date of index surgery until 2 weeks postoperatively.
Graft infection defined as clinical infection of the skin graft diagnosed by a physician or confirmed by microbiological culture, occurring within 2 weeks after initial tumor excision and split-thickness skin grafting to the lower leg.
7 secondary outcomes
Graft loss percentage graft take at 2 weeks
Time frame: From date of index surgery until 2 weeks postoperatively.
Reoperation within 2 weeks after index surgery
Time frame: From date of index surgery until 2 weeks postoperatively.
Bleeding within 2 weeks after index surgery
Time frame: From date of index surgery until 2 weeks postoperatively.
Complications within 3 months after index surgery
Time frame: From date of index surgery until 3 months postoperatively.
Mortality within 3 months weeks after index surgery
Time frame: From date of index surgery until 3 months postoperatively.
Length of hospital stay
Time frame: From date of index surgery until 3 months postoperatively.
Healthcare resource use within 3 months
Time frame: From date of index surgery until 3 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy (NPWT) and Traditional Dressing in people with Skin Transplantation and Skin Grafting, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pooya Rajabaleyan, MD, PhD (+4640331000, Pooya.rajabaleyan@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of transplant infection within 2 weeks after index surgery (time frame: From date of index surgery until 2 weeks postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.