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

Not Applicable

Recruiting

• Conditions: Negative-Pressure Wound Therapy; Diabetic Foot
• Interventions: Other: Ordinary dressings with antibiotic ointment and gauze; Device: Negative Pressure Wound Therapy (NPWT)

• Registration Number: NCT05716503
• Lead Sponsor: Sohag University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-27
• Study Start: 2023-02-01
• Study First Posted: 2023-02-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12
• Primary Completion: 2024-02
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (B)	Ordinary dressings with antibiotic ointment and gauze	Control group (B): Will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.
Study group (A)	Negative Pressure Wound Therapy (NPWT)	Study group (A): Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sohag university hospital; 🇪🇬 Sohag, Egypt