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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05716503
Collaborator
(none)
20
2
14

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Negative Pressure Wound Therapy (NPWT)
  • Other: Ordinary dressings with antibiotic ointment and gauze
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Supportive Care
Official Title:
Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group (A)

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

Experimental: Control group (B)

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

Outcome Measures

Primary Outcome Measures

  1. Period of hospitalization. [2 weeks]

    Number of days of patient hospitalization before and after grafting

  2. Time of complete healing [1 month]

    Number of days needed for each patient for complete healing after operation

  3. Functional outcome [5 months]

    Number of patients with full range of mobility at site of graft Vs number of patients with limited mobility

  4. Patient satisfaction of aesthetic outcome [5 months]

    Number of patients satisfied with the aesthetic result of the operation on a scale of 0-10

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hady Khaled Elhossiny, Resident of plastic and reconstructive surgery, Sohag University hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT05716503
Other Study ID Numbers:
  • Soh-Med-23-01-08
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023