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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.
Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.
Central Finland Hospital
Jyväskylä, Finland
Tampere University Hospital
Tampere, Finland
Between group difference in skin graft take
Split-thickness skin graft take ratio (percentage of surface area)
Time frame: 2 weeks after surgery
Between group difference in skin graft take
Split-thickness skin graft take ratio (percentage of surface area)
Time frame: 5 to 7 days after surgery
Between group difference in skin graft take
Split-thickness skin graft take ratio (percentage of surface area)
Time frame: 8 weeks after surgery
Strength of pain (wound)
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
Time frame: 5 to 7 days after surgery
Strength of pain (wound)
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
Time frame: 2 weeks
Strength of pain (wound)
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
Time frame: 8 weeks after surgery
Strength of pain (wound)
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
Time frame: 1 year after surgery
Strength of pain (donor site)
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
Time frame: 1 week after surgery
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Strength of pain (donor site)
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
Time frame: 2 weeks after surgery
Strength of pain (donor site)
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
Time frame: 8 weeks after surgery
Strength of pain (donor site)
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
Time frame: 1 year after surgery
POSAS score (wound)
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (wound)
Time frame: 8 weeks after surgery
POSAS score (wound)
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best)(wound)
Time frame: 1 year after surgery
POSAS score (donor site)
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)
Time frame: 8 weeks after surgery
POSAS score (donor site)
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)
Time frame: 1 year after surgery
Change in quality of life
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
Time frame: 5 to7 days after surgery
Change in quality of life
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
Time frame: 2 weeks after surgery
Change in quality of life
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
Time frame: 8 weeks after surgery
Change in quality of life
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
Time frame: 1 year after surgery
Overall satisfaction
Overall satisfaction with treatment (Likert)
Time frame: 5 to 7 days after surgery
Overall satisfaction
Overall satisfaction with treatment (Likert)
Time frame: 2 weeks after surgery
Overall satisfaction
Overall satisfaction with treatment (Likert)
Time frame: 8 weeks after surgery
Overall satisfaction
Overall satisfaction with treatment (Likert)
Time frame: 1 year after surgery
Strength of itching (wound)
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
Time frame: 5 to 7 days after surgery
Strength of itching (wound)
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
Time frame: 2 weeks after surgery
Strength of itching (wound)
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
Time frame: 8 weeks after surgery
Strength of itching (wound)
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
Time frame: 1 year after surgery
Strength of itching (donor site)
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
Time frame: 5 to 7 days after surgery
Strength of itching (donor site)
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
Time frame: 2 weeks after surgery
Strength of itching (donor site)
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
Time frame: 8 weeks after surgery
Strength of itching (donor site)
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
Time frame: 1 year after surgery
Length of stay
Length of hospital ward stay due to wound treatment (days)
Time frame: Until 8 weeks after surgery
Number of visits
Number of visits to hospital due to wound treatment
Time frame: Until 8 weeks after surgery