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Vacuum dressing could cut infections after skin graft surgery

NCT ID NCT07040683

Disease control Sponsor: Region Skane Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study tests whether a vacuum dressing (negative pressure wound therapy) reduces infection compared to standard bandages after skin graft surgery for leg tumors. About 242 adults will be randomly assigned to one of the two dressings. The main goal is to see if the vacuum dressing lowers infection rates within three months after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Negative pressure wound therapy (NPWT) device
What this could lead to
If it works, this could reduce infections and improve healing after skin grafts for leg tumors, leading to fewer reoperations and better outcomes.
What could go wrong
This is a mid-sized trial, and results may not apply to all patients. NPWT is already used in other settings, so the benefit here may be modest or not statistically significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 232 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

injury Postoperative Complications skin cancer skin neoplasm Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bandages LEG Lower extremity Negative-pressure wound therapy Postoperative complications Skin cancer Skin grafting Skin transplantation Skin tumour Split thickness skin graft Surgical wound infection Wound healing

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.

    RECRUITING

    Malmö, 20501, Sweden

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