Skin CancerNCT03452852
Prospective, RCT of Split Thickness Skin Grafts on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
A study testing PICO and Coban 2 lite in people with Skin Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The single center, prospective, randomized trial includes in total 60 patients. We want to compare two different treatment methods for compression therapy for split thickness skin graft in lower leg. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- PICO and Coban 2 lite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years
- Signed informed consent
- Surgical wound (excision of skin cancer)
Who cannot join
- Malignant melanoma
- Signs of infection
- Exposed tendon/bone in wound
- Burn/chronic wound
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Department of Plastic- and Reconstructive Surgery, Oslo university hospital - Rikshospitalet
Oslo, 0372
Martina Kristiansen, MD, +47 46809453, martk4@ous-hf.no
Thomas Moe Berg, MD, PhD, +47 41328958, thmobe@ous-hf.no
About this study
Official title: Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
The single center, prospective, randomized trial includes in total 60 patients. We want to compare two different treatment methods for compression therapy for split thickness skin graft in lower leg. The patients are randomized to compression therapy with NPWT (negative pressure wound therapy) using the device PICO or using the compression bandage with Coban 2 lite.
Primary outcome is complete healing of the skin transplant 30 days postoperatively. Secondary outcomes will be to note frequency of infection, bleeding, loss of transplant etc.
- Conditions
- Skin Cancer
- Being tested
- PICO, Coban 2 lite
- Keywords
- Split thickness skin graft, Lower leg, Compression therapy, PICO, Coban 2 lite
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICODevice
NPWT with PICO (Smith and Nephew)
Coban 2 liteOther
Compression bandaging with Coban 2 lite
| Study group | Role | What they receive |
|---|---|---|
| NPWT (PICO device) | Other | In this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers. Receives: Device: PICO |
| Compression bandaging (Coban 2 lite) | Other | In this arm, investigators will use the Coban 2 lite compression bandaging for compression therapy after split thickness skin graft of leg ulcers. Receives: Other: Coban 2 lite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of skin graft between the two Methods
Numbers of patients with 100 % healing of the split thickness skin graft
Measured: 30 days postoperatively
Secondary outcomes (3)
Percentage of healing between the two Methods
Average healing of the split thickness skin grafts
Measured: 30 days postoperatively
Evaluation of pain with VAS (Visual analogic scale)
Pain score as measured by VAS
Measured: 0, 5-7, 10-14 and 30 days postoperatively
Level of function
Evaluate change in daily function after surgery
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Mar 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Eva Kristiansen, Oslo University Hospital
- Investigators
- Thomas Moe Berg, MD, PhD, Principal investigator, Department of Plastic- and reconstructive surgery, Oslo university hospital - Rikshospitalet, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452852
- Sponsor's protocol ID
- 2017/1603-5
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
- ClinicalTrials.gov ID
- NCT03452852
- Acronym / sponsor ID
- 2017/1603-5
- Conditions
- Skin Cancer
- Keywords
- Split thickness skin graft, Lower leg, Compression therapy, PICO, Coban 2 lite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 Mar 2018 (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 single center, prospective, randomized trial includes in total 60 patients. We want to compare two different treatment methods for compression therapy for split thickness skin graft in lower leg. The patients are randomized to compression therapy with NPWT (negative pressure wound therapy) using the device PICO or using the compression bandage with Coban 2 lite.
Primary outcome is complete healing of the skin transplant 30 days postoperatively. Secondary outcomes will be to note frequency of infection, bleeding, loss of transplant etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPWT (PICO device) | Other | Device: PICOIn this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers. |
| Compression bandaging (Coban 2 lite) | Other | Other: Coban 2 liteIn this arm, investigators will use the Coban 2 lite compression bandaging for compression therapy after split thickness skin graft of leg ulcers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years
- Signed informed consent
- Surgical wound (excision of skin cancer)
Key exclusion criteria (4 listed)
- Malignant melanoma
- Signs of infection
- Exposed tendon/bone in wound
- Burn/chronic wound
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 |
|---|---|---|
| PICONPWT with PICO (Smith and Nephew) | Device | NPWT (PICO device) |
| Coban 2 liteCompression bandaging with Coban 2 lite | Other | Compression bandaging (Coban 2 lite) |
Primary outcome
Healing of skin graft between the two Methods
Time frame: 30 days postoperatively
Numbers of patients with 100 % healing of the split thickness skin graft
3 secondary outcomes
Percentage of healing between the two Methods
Time frame: 30 days postoperatively
Evaluation of pain with VAS (Visual analogic scale)
Time frame: 0, 5-7, 10-14 and 30 days postoperatively
Level of function
Time frame: 30 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
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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. This study is not recruiting at the moment.
Thomas Moe Berg, MD, PhD principal investigator
Department of Plastic- and reconstructive surgery, Oslo university hospital - Rikshospitalet, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO and Coban 2 lite in people with Skin Cancer, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Mar 2018. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Kristiansen, MD (+47 6809453, martk4@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of skin graft between the two Methods (time frame: 30 days 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 Mar 2018.