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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03649308
Other study ID # 6U/2018
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 19, 2018
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source Central Finland Hospital District
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Intervention

Device:
Negative Pressure Wound Therapy
An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.
Procedure:
Conventional treatment
Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.

Locations

Country Name City State
Finland Central Finland Hospital Jyväskylä
Finland Tampere University Hospital Tampere

Sponsors (3)

Lead Sponsor Collaborator
Central Finland Hospital District Tampere University Hospital, University of Eastern Finland

Country where clinical trial is conducted

Finland, 

References & Publications (3)

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

Outcome

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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