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Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting (TRUTH)

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ClinicalTrials.gov Identifier: NCT03649308
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
Tampere University Hospital
University of Eastern Finland
Information provided by (Responsible Party):
Central Finland Hospital District

Brief 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.

Condition or disease Intervention/treatment Phase
Wound of Skin Wound Heal Wound Wound Open Wound Breakdown Skin Wound Skin Scarring Device: Negative Pressure Wound Therapy Procedure: Conventional treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Negative Pressure Wound Therapy Compared to Traditional Care After Split-thickness Skin Grafting - a Randomized Controlled Trial
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Negative Pressure Wound Therapy
A 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.
Device: Negative Pressure Wound Therapy
An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.

Active Comparator: Conventional treatment
A conventional wound dressing is applied on wound in operating theatre, followed by immobilization for 5 days after split-thickness skin graft procedure.
Procedure: Conventional treatment
Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.




Primary Outcome Measures :
  1. Between group difference in skin graft take [ Time Frame: 2 weeks after surgery ]
    Split-thickness skin graft take ratio (percentage of surface area)


Secondary Outcome Measures :
  1. Between group difference in skin graft take [ Time Frame: 5 to 7 days after surgery ]
    Split-thickness skin graft take ratio (percentage of surface area)

  2. Between group difference in skin graft take [ Time Frame: 8 weeks after surgery ]
    Split-thickness skin graft take ratio (percentage of surface area)

  3. Strength of pain (wound) [ Time Frame: 5 to 7 days after surgery ]
    Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)

  4. Strength of pain (wound) [ Time Frame: 2 weeks ]
    Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)

  5. Strength of pain (wound) [ Time Frame: 8 weeks after surgery ]
    Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)

  6. Strength of pain (wound) [ Time Frame: 1 year after surgery ]
    Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)

  7. Strength of pain (donor site) [ Time Frame: 1 week after surgery ]
    Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)

  8. Strength of pain (donor site) [ Time Frame: 2 weeks after surgery ]
    Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)

  9. Strength of pain (donor site) [ Time Frame: 8 weeks after surgery ]
    Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)

  10. Strength of pain (donor site) [ Time Frame: 1 year after surgery ]
    Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)

  11. POSAS score (wound) [ Time Frame: 8 weeks after surgery ]
    Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (wound)

  12. POSAS score (wound) [ Time Frame: 1 year after surgery ]
    Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best)(wound)

  13. POSAS score (donor site) [ Time Frame: 8 weeks after surgery ]
    Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)

  14. POSAS score (donor site) [ Time Frame: 1 year after surgery ]
    Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)

  15. Change in quality of life [ Time Frame: 5 to7 days after surgery ]
    Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)

  16. Change in quality of life [ Time Frame: 2 weeks after surgery ]
    Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)

  17. Change in quality of life [ Time Frame: 8 weeks after surgery ]
    Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)

  18. Change in quality of life [ Time Frame: 1 year after surgery ]
    Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)

  19. Overall satisfaction [ Time Frame: 5 to 7 days after surgery ]
    Overall satisfaction with treatment (Likert)

  20. Overall satisfaction [ Time Frame: 2 weeks after surgery ]
    Overall satisfaction with treatment (Likert)

  21. Overall satisfaction [ Time Frame: 8 weeks after surgery ]
    Overall satisfaction with treatment (Likert)

  22. Overall satisfaction [ Time Frame: 1 year after surgery ]
    Overall satisfaction with treatment (Likert)

  23. Strength of itching (wound) [ Time Frame: 5 to 7 days after surgery ]
    Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)

  24. Strength of itching (wound) [ Time Frame: 2 weeks after surgery ]
    Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)

  25. Strength of itching (wound) [ Time Frame: 8 weeks after surgery ]
    Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)

  26. Strength of itching (wound) [ Time Frame: 1 year after surgery ]
    Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)

  27. Strength of itching (donor site) [ Time Frame: 5 to 7 days after surgery ]
    Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)

  28. Strength of itching (donor site) [ Time Frame: 2 weeks after surgery ]
    Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)

  29. Strength of itching (donor site) [ Time Frame: 8 weeks after surgery ]
    Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)

  30. Strength of itching (donor site) [ Time Frame: 1 year after surgery ]
    Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)

  31. Length of stay [ Time Frame: Until 8 weeks after surgery ]
    Length of hospital ward stay due to wound treatment (days)

  32. Number of visits [ Time Frame: Until 8 weeks after surgery ]
    Number of visits to hospital due to wound treatment


Other Outcome Measures:
  1. Contamination [ Time Frame: Immediately before skin graft procedure and antimicrobial prophylaxis ]
    Type of bacterial flora in wound

  2. Contamination [ Time Frame: After revision during skin graft procedure ]
    Type of bacterial flora in wound

  3. Contamination [ Time Frame: 5 to 7 days after skin graft procedure ]
    Type of bacterial flora in wound



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Wound requiring skin graft surgery
  • Voluntary

Exclusion Criteria:

  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649308


Contacts
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Contact: Juho Salivaara, MD +358 14 269 1811 juho.salivaara@ksshp.fi
Contact: Kristiina Hietanen, MD +358 14 269 1811 kristiina.hietanen@ksshp.fi

Locations
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Finland
Central Finland Hospital Recruiting
Jyväskylä, Finland, 40620
Contact: Juha Paloneva, MD, PhD    +358 14 2693119      
Contact: Kristiina Hietanen, MD       kristiina.hietanen@ksshp.fi   
Principal Investigator: Juha Paloneva, MD, PhD         
Sub-Investigator: Kristiina Hietanen, MD         
Sub-Investigator: Juho Salivaara, MD         
Sub-Investigator: Jussi Repo, MD, PhD         
Sponsors and Collaborators
Central Finland Hospital District
Tampere University Hospital
University of Eastern Finland
Investigators
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Principal Investigator: Juha Paloneva, professor Deparment head

Publications:
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Responsible Party: Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT03649308    
Other Study ID Numbers: 6U/2018
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Central Finland Hospital District:
Negative pressure wound therapy
Skin graft
split-thickness skin graft
Additional relevant MeSH terms:
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Surgical Wound Dehiscence
Wounds and Injuries
Pathologic Processes
Postoperative Complications