Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting (TRUTH)

Central Finland Hospital District

Status: Active, not recruiting

Conditions: Wound Open; Wound Breakdown; Wound; Skin Scarring; Wound of Skin; Wound Heal; Skin Wound

Treatments: Procedure: Conventional treatment; Device: Negative Pressure Wound Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03649308

6U/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Negative Pressure Wound Therapy

Experimental group

Description:

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.

Treatment:

Device: Negative Pressure Wound Therapy

Conventional treatment

Active Comparator group

Description:

A conventional wound dressing is applied on wound in operating theatre, followed by immobilization for 5 days after split-thickness skin graft procedure.

Treatment:

Procedure: Conventional treatment