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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
| University of Eastern Finland | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy | Experimental | 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. |
|
| Conventional treatment | Active Comparator | A conventional wound dressing is applied on wound in operating theatre, followed by immobilization for 5 days after split-thickness skin graft procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Device | An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery. |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Contamination | Type of bacterial flora in wound | Immediately before skin graft procedure and antimicrobial prophylaxis |
| Contamination | Type of bacterial flora in wound |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juha Paloneva, professor | Chief medical director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Finland Hospital | Jyväskylä | 40620 | Finland | |||
| Tampere University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26940940 | Background | 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. | |
| 24577227 | Background |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013529 | Surgical Wound Dehiscence |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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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.
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| Conventional treatment | Procedure | Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery. |
|
| 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 |
| After revision during skin graft procedure |
| Contamination | Type of bacterial flora in wound | 5 to 7 days after skin graft procedure |
| Tampere |
| 33521 |
| Finland |
| 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. |
| 20825510 | Background | 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. |