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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05716503
Enrollment
20
Registered
2023-02-08
Start date
2023-02-01
Completion date
2024-04-30
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Negative-Pressure Wound Therapy, Diabetic Foot

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.

Interventions

Patients Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting.

OTHEROrdinary dressings with antibiotic ointment and gauze

Patients will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Period of hospitalization.2 weeksNumber of days of patient hospitalization before and after grafting
Time of complete healing1 monthNumber of days needed for each patient for complete healing after operation
Functional outcome5 monthsNumber of patients with full range of mobility at site of graft Vs number of patients with limited mobility
Patient satisfaction of aesthetic outcome5 monthsNumber of patients satisfied with the aesthetic result of the operation on a scale of 0-10

Countries

Egypt

Contacts

Primary ContactHady K Elhossiny, Resident
dr_hady_94@yahoo.com01096816840
Backup ContactGamal Y Elsayed, Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026