search
Back to results

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

Primary Purpose

Negative-Pressure Wound Therapy, Diabetic Foot

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy (NPWT)
Ordinary dressings with antibiotic ointment and gauze
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Negative-Pressure Wound Therapy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sohag university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Study group (A)

Control group (B)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 18, 2023
Last Updated
April 11, 2023
Sponsor
Sohag University
search

1. Study Identification

Unique Protocol Identification Number
NCT05716503
Brief Title
Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds
Official Title
Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative-Pressure Wound Therapy, Diabetic Foot

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group (A)
Arm Type
Experimental
Arm Description
Study group (A): Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting.
Arm Title
Control group (B)
Arm Type
Experimental
Arm Description
Control group (B): Will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.
Intervention Type
Device
Intervention Name(s)
Negative Pressure Wound Therapy (NPWT)
Intervention Description
Patients Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting.
Intervention Type
Other
Intervention Name(s)
Ordinary dressings with antibiotic ointment and gauze
Intervention Description
Patients will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.
Primary Outcome Measure Information:
Title
Period of hospitalization.
Description
Number of days of patient hospitalization before and after grafting
Time Frame
2 weeks
Title
Time of complete healing
Description
Number of days needed for each patient for complete healing after operation
Time Frame
1 month
Title
Functional outcome
Description
Number of patients with full range of mobility at site of graft Vs number of patients with limited mobility
Time Frame
5 months
Title
Patient satisfaction of aesthetic outcome
Description
Number of patients satisfied with the aesthetic result of the operation on a scale of 0-10
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hady K Elhossiny, Resident
Phone
01096816840
Email
dr_hady_94@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gamal Y Elsayed, Professor
Facility Information:
Facility Name
Sohag university hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hady K Elkhayat, Resident
Email
dr.hady.94@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23878741
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.
Results Reference
background
PubMed Identifier
24765245
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.
Results Reference
background
PubMed Identifier
26654318
Citation
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.
Results Reference
background
PubMed Identifier
23723599
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs