Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Wound of Skin Wound Heal Wound Wound Open Wound Breakdown Skin Wound Skin Scarring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy

Intervention Type DEVICE

An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.

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.

Group Type ACTIVE_COMPARATOR

Conventional treatment

Intervention Type PROCEDURE

Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.

Interventions

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Negative Pressure Wound Therapy

An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.

Intervention Type DEVICE

Conventional treatment

Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No