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

NCT ID: NCT05716503

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Negative-Pressure Wound Therapy Diabetic Foot

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy (NPWT)

Intervention Type DEVICE

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

Control group (B)

Control group (B): Will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.

Group Type EXPERIMENTAL

Ordinary dressings with antibiotic ointment and gauze

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Ordinary dressings with antibiotic ointment and gauze

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hady Khaled Elhossiny

Resident of plastic and reconstructive surgery, Sohag University hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag university hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hady K Elhossiny, Resident

Role: CONTACT

01096816840

Gamal Y Elsayed, Professor

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hady K Elkhayat, Resident

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23878741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24765245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26654318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23723599 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med-23-01-08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.