Clinical trial NCT03649308: Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting
Official title: Negative Pressure Wound Therapy Compared to Traditional Care After Split-thickness Skin Grafting - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Wound of Skin
Wound Heal
Wound
Wound Open
Wound Breakdown
Skin Wound
Skin Scarring
Keywords: Negative pressure wound therapy
Skin graft
split-thickness skin graft
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: University of Eastern Finland
First posted: 2018-08-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Between group difference in skin graft take
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Between group difference in skin graft take
timeFrame: 5 to 7 days after surgery
measure: Between group difference in skin graft take
timeFrame: 8 weeks after surgery
measure: Strength of pain (wound)
timeFrame: 5 to 7 days after surgery
measure: Strength of pain (wound)
timeFrame: 2 weeks
measure: Strength of pain (wound)
timeFrame: 8 weeks after surgery
measure: Strength of pain (wound)
timeFrame: 1 year after surgery
measure: Strength of pain (donor site)
timeFrame: 1 week after surgery
measure: Strength of pain (donor site)
timeFrame: 2 weeks after surgery
measure: Strength of pain (donor site)
timeFrame: 8 weeks after surgery
measure: Strength of pain (donor site)
timeFrame: 1 year after surgery
measure: POSAS score (wound)
timeFrame: 8 weeks after surgery
measure: POSAS score (wound)
timeFrame: 1 year after surgery
measure: POSAS score (donor site)
timeFrame: 8 weeks after surgery
measure: POSAS score (donor site)
timeFrame: 1 year after surgery
measure: Change in quality of life
timeFrame: 5 to7 days after surgery
measure: Change in quality of life
timeFrame: 2 weeks after surgery
measure: Change in quality of life
timeFrame: 8 weeks after surgery
measure: Change in quality of life
timeFrame: 1 year after surgery
measure: Overall satisfaction
timeFrame: 5 to 7 days after surgery
measure: Overall satisfaction
timeFrame: 2 weeks after surgery
measure: Overall satisfaction
timeFrame: 8 weeks after surgery
measure: Overall satisfaction
timeFrame: 1 year after surgery
measure: Strength of itching (wound)
timeFrame: 5 to 7 days after surgery
measure: Strength of itching (wound)
timeFrame: 2 weeks after surgery
measure: Strength of itching (wound)
timeFrame: 8 weeks after surgery
measure: Strength of itching (wound)
timeFrame: 1 year after surgery
measure: Strength of itching (donor site)
timeFrame: 5 to 7 days after surgery
measure: Strength of itching (donor site)
timeFrame: 2 weeks after surgery
measure: Strength of itching (donor site)
timeFrame: 8 weeks after surgery
measure: Strength of itching (donor site)
timeFrame: 1 year after surgery
measure: Length of stay
timeFrame: Until 8 weeks after surgery
measure: Number of visits
timeFrame: Until 8 weeks after surgery
Other outcomes:
measure: Contamination
timeFrame: Immediately before skin graft procedure and antimicrobial prophylaxis
measure: Contamination
timeFrame: After revision during skin graft procedure
measure: Contamination
timeFrame: 5 to 7 days after skin graft procedure
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Chief medical director
name: Juha Paloneva, professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.