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Wound of SkinTRUTHNCT03649308

Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting

A study testing Negative Pressure Wound Therapy and Conventional treatment in people with Wound of Skin and Wound Heal, run by Central Finland Hospital District at 2 sites in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to compare negative pressure wound therapy to traditional care after split-thickness skin grafting in patients aged over 18. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Wound of Skin, Wound Heal, Wound
What is being tested?
Negative Pressure Wound Therapy and Conventional treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
2 sitesFinland
Study dates
19 Sep 2018to 31 Dec 2025
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Wound requiring skin graft surgery
  • Voluntary

Who cannot join

  • Not voluntary
  • Size of wound exceeding 15x15cm or 5x20cm
  • Previous skin graft operation to the same wound
  • Inability to co-operate
  • Wound depth over 1.5cm
  • Multiple wounds requiring skin grafting
Show all 10Show fewer
  • Active infection in wound
  • Active osteomyelitis in region of wound
  • Flap reconstruction of the wound
  • Region of wound not suitable for negative pressure wound therapy (for example toes, foot sole)

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

  • Central Finland Hospital

    Jyväskylä, 40620

  • Tampere University Hospital

    Tampere, 33521

Other trials in Finland

About this study

Official title: Negative Pressure Wound Therapy Compared to Traditional Care After Split-thickness Skin Grafting - a Randomized Controlled Trial

The aim of this study is to compare negative pressure wound therapy to traditional care after split-thickness skin grafting in patients aged over 18.

Read the detailed description

Split-thickness skin grafting (STSG) is one of the most commonly used techniques in reconstructive plastic surgery and dermatology. Skin grafts are being used to cover skin defects caused by multiple etiologies. Traditionally, patients are immobilized in bed or in wheelchair for up to five days after surgery. Long immobilization decreases patients overall ability to function and increases the length of the stay in hospital. Negative pressure wound therapy (NPWT) have been used successfully in treatment of acute, chronic and diabetic ulcers. It is proposed that NPWT increases capillary blood flow, decreases bacterial contamination, seroma formation and swelling. Using NPWT on split-thickness skin grafts after burns is well documented. It increases skin graft take ratio and speeds up healing. Aim of this study is to compare NPWT to traditional treatment after STSG for any indication in patients aged 18 to 99. This is a two-arm, multicenter, randomized prospective trial with 160 patients.

Being tested
Negative Pressure Wound Therapy, Conventional treatment
Keywords
Negative pressure wound therapy, Skin graft, split-thickness skin graft
Medical subject headings
Wounds and Injuries, Surgical Wound Dehiscence, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Negative Pressure Wound TherapyDevice

    An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.

  • Conventional treatmentProcedure or surgery

    Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.

Study groups in NCT03649308
Study groupRoleWhat they receive
Negative Pressure Wound TherapyExperimentalA negative pressure wound therapy device (PICO) is applied on split-thickness skin graft for 5 to 7 days from surgery in operating theatre. The patient can be mobilized immediately after skin graft procedure.
Receives: Device: Negative Pressure Wound Therapy
Conventional treatmentActive comparatorA conventional wound dressing is applied on wound in operating theatre, followed by immobilization for 5 days after split-thickness skin graft procedure.
Receives: Procedure: Conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Between group difference in skin graft take

    Split-thickness skin graft take ratio (percentage of surface area)

    Measured: 2 weeks after surgery

Secondary outcomes (32)

  1. Between group difference in skin graft take

    Split-thickness skin graft take ratio (percentage of surface area)

    Measured: 5 to 7 days after surgery

  2. Between group difference in skin graft take

    Split-thickness skin graft take ratio (percentage of surface area)

    Measured: 8 weeks after surgery

  3. Strength of pain (wound)

    Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)

    Measured: 5 to 7 days after surgery

  4. Strength of pain (wound)

    Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)

    Measured: 2 weeks

  5. Strength of pain (wound)

    Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)

    Measured: 8 weeks after surgery

  6. Strength of pain (wound)

    Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)

    Measured: 1 year after surgery

  7. Strength of pain (donor site)

    Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)

    Measured: 1 week after surgery

  8. Strength of pain (donor site)

    Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)

    Measured: 2 weeks after surgery

  9. Strength of pain (donor site)

    Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)

    Measured: 8 weeks after surgery

  10. Strength of pain (donor site)

    Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)

    Measured: 1 year after surgery

  11. POSAS score (wound)

    Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (wound)

    Measured: 8 weeks after surgery

  12. POSAS score (wound)

    Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best)(wound)

    Measured: 1 year after surgery

  13. POSAS score (donor site)

    Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)

    Measured: 8 weeks after surgery

  14. POSAS score (donor site)

    Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)

    Measured: 1 year after surgery

  15. Change in quality of life

    Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)

    Measured: 5 to7 days after surgery

  16. Change in quality of life

    Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)

    Measured: 2 weeks after surgery

  17. Change in quality of life

    Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)

    Measured: 8 weeks after surgery

  18. Change in quality of life

    Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)

    Measured: 1 year after surgery

  19. Overall satisfaction

    Overall satisfaction with treatment (Likert)

    Measured: 5 to 7 days after surgery

  20. Overall satisfaction

    Overall satisfaction with treatment (Likert)

    Measured: 2 weeks after surgery

  21. Overall satisfaction

    Overall satisfaction with treatment (Likert)

    Measured: 8 weeks after surgery

  22. Overall satisfaction

    Overall satisfaction with treatment (Likert)

    Measured: 1 year after surgery

  23. Strength of itching (wound)

    Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)

    Measured: 5 to 7 days after surgery

  24. Strength of itching (wound)

    Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)

    Measured: 2 weeks after surgery

  25. Strength of itching (wound)

    Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)

    Measured: 8 weeks after surgery

  26. Strength of itching (wound)

    Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)

    Measured: 1 year after surgery

  27. Strength of itching (donor site)

    Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)

    Measured: 5 to 7 days after surgery

  28. Strength of itching (donor site)

    Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)

    Measured: 2 weeks after surgery

  29. Strength of itching (donor site)

    Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)

    Measured: 8 weeks after surgery

  30. Strength of itching (donor site)

    Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)

    Measured: 1 year after surgery

  31. Length of stay

    Length of hospital ward stay due to wound treatment (days)

    Measured: Until 8 weeks after surgery

  32. Number of visits

    Number of visits to hospital due to wound treatment

    Measured: Until 8 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start19 Sep 2018
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
After split-thickness skin graft procedure, the participants are assigned to either conventional treatment or negative pressure wound therapy group in parallel for the duration of the study.
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649308
Sponsor's protocol ID
6U/2018
Acronym
TRUTH
Status last verified
Feb 2024
First submitted
24 Aug 2018
Last updated
13 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Serra R, Rizzuto A, Rossi A, Perri P, Barbetta A, Abdalla K, Caroleo S, Longo C, Amantea B, Sammarco G, de Franciscis S. Skin grafting for the treatment of chronic leg ulcers - a systematic review in evidence-based medicine. Int Wound J. 2017 Feb;14(1):149-157. doi: 10.1111/iwj.12575. Epub 2016 Mar 4.

    PubMed 26940940

  • Waltzman JT, Bell DE. Vacuum-assisted closure device as a split-thickness skin graft bolster in the burn population. J Burn Care Res. 2014 Sep-Oct;35(5):e338-42. doi: 10.1097/BCR.0000000000000009.

    PubMed 24577227

  • Blume PA, Key JJ, Thakor P, Thakor S, Sumpio B. Retrospective evaluation of clinical outcomes in subjects with split-thickness skin graft: comparing V.A.C.(R) therapy and conventional therapy in foot and ankle reconstructive surgeries. Int Wound J. 2010 Dec;7(6):480-7. doi: 10.1111/j.1742-481X.2010.00728.x. Epub 2010 Sep 6.

    PubMed 20825510

Questions about this trial

What is this clinical trial studying?

A study testing Negative Pressure Wound Therapy and Conventional treatment in people with Wound of Skin and Wound Heal, run by Central Finland Hospital District at 2 sites in Finland.

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 2 inclusion and 10 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Finland. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between group difference in skin graft take (time frame: 2 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649308, which also lists 3 linked publications.

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 13 Feb 2024.

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