Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting

Not Applicable

Active, not recruiting

• Conditions: Skin Scarring; Wound of Skin; Wound Heal; Wound Breakdown; Skin Wound; Wound; Wound Open
• Interventions: Procedure: Conventional treatment; Device: Negative Pressure Wound Therapy

• Registration Number: NCT03649308
• Lead Sponsor: Central Finland Hospital District

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.

Study Timeline

• Study First Submitted: 2018-08-24
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-28
• Study Start: 2018-09-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment	Conventional treatment	A conventional wound dressing is applied on wound in operating theatre, followed by immobilization for 5 days after split-thickness skin graft procedure.
Negative Pressure Wound Therapy	Negative Pressure Wound Therapy	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.

Primary Outcome Measures

Name	Time	Method
Between group difference in skin graft take	2 weeks after surgery	Split-thickness skin graft take ratio (percentage of surface area)

Secondary Outcome Measures

Name	Time	Method
Strength of pain (wound)	1 year after surgery	Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
Between group difference in skin graft take	8 weeks after surgery	Split-thickness skin graft take ratio (percentage of surface area)
Strength of pain (donor site)	1 year after surgery	Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
Number of visits	Until 8 weeks after surgery	Number of visits to hospital due to wound treatment
POSAS score (wound)	1 year after surgery	Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best)(wound)
POSAS score (donor site)	1 year after surgery	Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)
Change in quality of life	1 year after surgery	Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
Strength of itching (wound)	1 year after surgery	Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
Strength of itching (donor site)	1 year after surgery	Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
Length of stay	Until 8 weeks after surgery	Length of hospital ward stay due to wound treatment (days)
Overall satisfaction	1 year after surgery	Overall satisfaction with treatment (Likert)

Trial Locations

Locations (2)

Central Finland Hospital; 🇫🇮 Jyväskylä, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland