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

April 11, 2023 updated by: Hady Khaled Elhossiny, Sohag University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Period of hospitalization.
Time Frame: 2 weeks
Number of days of patient hospitalization before and after grafting
2 weeks
Time of complete healing
Time Frame: 1 month
Number of days needed for each patient for complete healing after operation
1 month
Functional outcome
Time Frame: 5 months
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
Time Frame: 5 months
Number of patients satisfied with the aesthetic result of the operation on a scale of 0-10
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-01-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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