Wound Heal Clinical Trial
— TRUTHOfficial title:
Negative Pressure Wound Therapy Compared to Traditional Care After Split-thickness Skin Grafting - a Randomized Controlled Trial
Verified date | February 2024 |
Source | Central Finland Hospital District |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 160 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Finland | Central Finland Hospital | Jyväskylä | |
Finland | Tampere University Hospital | Tampere |
Lead Sponsor | Collaborator |
---|---|
Central Finland Hospital District | Tampere University Hospital, University of Eastern Finland |
Finland,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Contamination | Type of bacterial flora in wound | Immediately before skin graft procedure and antimicrobial prophylaxis | |
Other | Contamination | Type of bacterial flora in wound | After revision during skin graft procedure | |
Other | Contamination | Type of bacterial flora in wound | 5 to 7 days after skin graft procedure | |
Primary | Between group difference in skin graft take | Split-thickness skin graft take ratio (percentage of surface area) | 2 weeks after surgery | |
Secondary | Between group difference in skin graft take | Split-thickness skin graft take ratio (percentage of surface area) | 5 to 7 days after surgery | |
Secondary | Between group difference in skin graft take | Split-thickness skin graft take ratio (percentage of surface area) | 8 weeks after surgery | |
Secondary | Strength of pain (wound) | Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain) | 5 to 7 days after surgery | |
Secondary | Strength of pain (wound) | Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain) | 2 weeks | |
Secondary | Strength of pain (wound) | Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain) | 8 weeks after surgery | |
Secondary | Strength of pain (wound) | Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain) | 1 year after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | POSAS score (wound) | Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (wound) | 8 weeks after surgery | |
Secondary | POSAS score (wound) | Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best)(wound) | 1 year after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Overall satisfaction | Overall satisfaction with treatment (Likert) | 5 to 7 days after surgery | |
Secondary | Overall satisfaction | Overall satisfaction with treatment (Likert) | 2 weeks after surgery | |
Secondary | Overall satisfaction | Overall satisfaction with treatment (Likert) | 8 weeks after surgery | |
Secondary | Overall satisfaction | Overall satisfaction with treatment (Likert) | 1 year after surgery | |
Secondary | Strength of itching (wound) | Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching) | 5 to 7 days after surgery | |
Secondary | Strength of itching (wound) | Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching) | 2 weeks after surgery | |
Secondary | Strength of itching (wound) | Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching) | 8 weeks after surgery | |
Secondary | Strength of itching (wound) | Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching) | 1 year after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Length of stay | Length of hospital ward stay due to wound treatment (days) | Until 8 weeks after surgery | |
Secondary | Number of visits | Number of visits to hospital due to wound treatment | Until 8 weeks after surgery |
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