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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Negative-Pressure Wound Therapy, Diabetic Foot

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy (NPWT)
* Other: Ordinary dressings with antibiotic ointment and gauze


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will randomly be divided into two groups - study group and control group. Study group (A): Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting. Control group (B): Will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group (A)<br>Study group (A): Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting. | Device: Negative Pressure Wound Therapy (NPWT)<br>* Patients Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting.<br>|
| Experimental: Control group (B)<br>Control group (B): Will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting. | Other: Ordinary dressings with antibiotic ointment and gauze<br>* Patients will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period of hospitalization. | Number of days of patient hospitalization before and after grafting | 2 weeks | 
| Time of complete healing | Number of days needed for each patient for complete healing after operation | 1 month | 
| Functional outcome | Number of patients with full range of mobility at site of graft Vs number of patients with limited mobility | 5 months | 
| Patient satisfaction of aesthetic outcome | Number of patients satisfied with the aesthetic result of the operation on a scale of 0-10 | 5 months |