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

NCT05716503 | Unknown

• 1 other identifier: Soh-Med-23-01-08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Negative-Pressure Wound Therapy; Diabetic Foot

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Study group (A)

EXPERIMENTAL

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)

Control group (B)

EXPERIMENTAL

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

Interventions

Negative Pressure Wound Therapy (NPWT) DEVICE

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

Study group (A)

Ordinary dressings with antibiotic ointment and gauze OTHER

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

Control group (B)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 23878741 BACKGROUND

• 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.

  PMID: 24765245 BACKGROUND

• 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.

  PMID: 26654318 BACKGROUND

• 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.

  PMID: 23723599 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Central Study Contacts

Hady K Elhossiny, Resident

CONTACT

01096816840; dr_hady_94@yahoo.com

Gamal Y Elsayed, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of plastic and reconstructive surgery, Sohag University hospital

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 8, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

EG (1)