Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds

Sohag University

Status: Enrolling

Conditions: Diabetic Foot; Negative-Pressure Wound Therapy

Treatments: Other: Ordinary dressings with antibiotic ointment and gauze; Device: Negative Pressure Wound Therapy (NPWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05716503

Soh-Med-23-01-08

Details and patient eligibility

About

The aim of this thesis is to compare the efficacy of Vacuum assisted closure device versus conventional dressing before and after split thickness skin grafting in diabetic foot wounds.

Full description

Negative pressure wound therapy is a new noninvasive technique for treating open wounds. It works by removing fluid from the wound bed, reducing edema, and encouraging the growth and perfusion of new granulation tissue.

Vacuum-Assisted Closure device (VAC) helps to remove fluid from open wounds through a sealed dressing and tubing which is connected to a collection container. Vacuum-assisted closure (VAC) can provide stable and persistent negative pressure, and there are several modes to choose from.

VAC has played an important role in helping to close wounds, controlling infection, promoting angiogenesis, increasing blood flow, and promoting granulation tissue growth in wounds. It is now widely applied in all kinds of acute, chronic, and special wounds with good therapeutic results. However, there is a need to pay attention to contraindications and complications of VAC when it is used, avoiding secondary damage due to improper treatment.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age group 20-75 years.
• Patients with diabetic foot wounds who are scheduled for skin grafting.

Exclusion criteria

• Age <20 years or > 75 years.
• An obvious septicemia.
• Foot osteomyelitis.
• Ulcer resulting from venous insufficiency.
• Features of malignant ulcer.
• Patients being treated with corticosteroids, immunosuppressive drugs.
• Any other serious pre-existing cardiovascular, pulmonary or immunological disease.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Study group (A)

Experimental group

Description:

Study group (A): Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting.

Treatment:

Device: Negative Pressure Wound Therapy (NPWT)

Control group (B)

Experimental group

Description:

Control group (B): Will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.

Treatment:

Other: Ordinary dressings with antibiotic ointment and gauze