Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wound of Skin, Wound Heal, Wound, Wound Open, Wound Breakdown, Skin Wound, Skin Scarring

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy
* Procedure: Conventional treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative Pressure Wound Therapy<br>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<br>* An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.<br>|
| Active Comparator: Conventional treatment<br>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<br>* Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group difference in skin graft take | Split-thickness skin graft take ratio (percentage of surface area) | 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group difference in skin graft take | Split-thickness skin graft take ratio (percentage of surface area) | 5 to 7 days after surgery | 
| Between group difference in skin graft take | Split-thickness skin graft take ratio (percentage of surface area) | 8 weeks after surgery | 
| Strength of pain (wound) | Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain) | 5 to 7 days after surgery | 
| Strength of pain (wound) | Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain) | 2 weeks | 
| Strength of pain (wound) | Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain) | 8 weeks after surgery | 
| Strength of pain (wound) | Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain) | 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) | 1 week after surgery | 
| Strength of pain (donor site) | Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain) | 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) | 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) | 1 year after surgery | 
| POSAS score (wound) | Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (wound) | 8 weeks after surgery | 
| POSAS score (wound) | Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best)(wound) | 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) | 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) | 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) | 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) | 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) | 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) | 1 year after surgery | 
| Overall satisfaction | Overall satisfaction with treatment (Likert) | 5 to 7 days after surgery | 
| Overall satisfaction | Overall satisfaction with treatment (Likert) | 2 weeks after surgery | 
| Overall satisfaction | Overall satisfaction with treatment (Likert) | 8 weeks after surgery | 
| Overall satisfaction | Overall satisfaction with treatment (Likert) | 1 year after surgery | 
| Strength of itching (wound) | Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching) | 5 to 7 days after surgery | 
| Strength of itching (wound) | Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching) | 2 weeks after surgery | 
| Strength of itching (wound) | Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching) | 8 weeks after surgery | 
| Strength of itching (wound) | Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching) | 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) | 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) | 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) | 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) | 1 year after surgery | 
| Length of stay | Length of hospital ward stay due to wound treatment (days) | Until 8 weeks after surgery | 
| Number of visits | Number of visits to hospital due to wound treatment | Until 8 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Negative pressure wound therapy, Skin graft, split-thickness skin graft