Skin Scarring, Skin Wound, Wound, Wound Breakdown, Wound Heal, Wound of Skin, Wound Open
Conditions
Keywords
Negative pressure wound therapy, Skin graft, split-thickness skin graft
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.
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.
Interventions
DEVICENegative Pressure Wound Therapy
An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.
PROCEDUREConventional treatment
Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.
Sponsors
Tampere University Hospital
University of Eastern Finland
Central Finland Hospital District
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between group difference in skin graft take | 2 weeks after surgery | Split-thickness skin graft take ratio (percentage of surface area) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between group difference in skin graft take | 5 to 7 days after surgery | Split-thickness skin graft take ratio (percentage of surface area) |
| Strength of pain (wound) | 5 to 7 days after surgery | Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain) |
| Strength of pain (donor site) | 1 week after surgery | Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain) |
| POSAS score (wound) | 8 weeks after surgery | Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (wound) |
| POSAS score (donor site) | 8 weeks after surgery | Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site) |
| Overall satisfaction | 5 to 7 days after surgery | Overall satisfaction with treatment (Likert) |
| Strength of itching (wound) | 5 to 7 days after surgery | Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching) |
| Strength of itching (donor site) | 5 to 7 days after surgery | Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching) |
| Length of stay | Until 8 weeks after surgery | Length of hospital ward stay due to wound treatment (days) |
| Number of visits | Until 8 weeks after surgery | Number of visits to hospital due to wound treatment |
| Change in quality of life | 5 to7 days after surgery | Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Contamination | Immediately before skin graft procedure and antimicrobial prophylaxis | Type of bacterial flora in wound |
Countries
Finland
Outcome results
None listed