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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716503
• Other study ID #: Soh-Med-23-01-08
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: April 2023
• Source: Sohag University
• Contact: Hady K Elhossiny, Resident
• Phone: 01096816840
• Email: dr_hady_94[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Negative-Pressure Wound Therapy
• Wounds and Injuries

Intervention

Device:
• Negative Pressure Wound Therapy (NPWT)
Patients Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting.

Other:
• Ordinary dressings with antibiotic ointment and gauze
Patients will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.

Locations

Country	Name	City	State
Egypt	Sohag university hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Ali Z, Anjum A, Khurshid L, Ahad H, Maajid S, Dhar SA. Evaluation of low-cost custom made VAC therapy compared with conventional wound dressings in the treatment of non-healing lower limb ulcers in lower socio-economic group patients of Kashmir valley. J Orthop Surg Res. 2015 Dec 10;10:183. doi: 10.1186/s13018-015-0314-5. — View Citation

Lone AM, Zaroo MI, Laway BA, Pala NA, Bashir SA, Rasool A. Vacuum-assisted closure versus conventional dressings in the management of diabetic foot ulcers: a prospective case-control study. Diabet Foot Ankle. 2014 Apr 8;5. doi: 10.3402/dfa.v5.23345. eCollection 2014. — View Citation

Ravari H, Modaghegh MH, Kazemzadeh GH, Johari HG, Vatanchi AM, Sangaki A, Shahrodi MV. Comparision of vacuum-asisted closure and moist wound dressing in the treatment of diabetic foot ulcers. J Cutan Aesthet Surg. 2013 Jan;6(1):17-20. doi: 10.4103/0974-2077.110091. — View Citation

Sinha K, Chauhan VD, Maheshwari R, Chauhan N, Rajan M, Agrawal A. Vacuum Assisted Closure Therapy versus Standard Wound Therapy for Open Musculoskeletal Injuries. Adv Orthop. 2013;2013:245940. doi: 10.1155/2013/245940. Epub 2013 Jun 26. — View Citation

Outcome

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