Comparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers

NCT ID: NCT03701152

Last Updated: 2018-10-09

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-01

Brief Summary

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

Negative Pressure Wound Therapy (NPWT), is a non invasive wound management tool which develops from negative pressure being applied to the wound. This promotes healing through the removal of infectious materials and enhancing granulation tissue formation. NPWT eases debridement as well as promoting healing of different types of wounds.

Detailed Description

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

Assessment of wound surface area was done by a graded plastic sheet and a metric graph paper, by counting the complete squares of the metric graph paper, while the wound size was done by using a 10 cm syringe filled with dermazin cream and filling the wound with it.

Negative pressure device: VAC system 125mmhg (KCI negative pressure equipment).

Wound surface area tracing tools:

* Sterilized transparent film.
* Fine tipped transparent marker.
* Carbon and a white A4 papers.
* Metric graph paper (1mm²).

Wound volume assessment procedure:

* Using a syringe of ten cubic centimeters filled with dermazin cream.
* The wound is filled with the cream
* The amount of cream injected into the wound was detected in cubic centimeters.

Conditions

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

Chronic Ulcers Negative Pressure Therapy

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

Negative pressure therapy

Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Continuous course

Group Type EXPERIMENTAL

Negative pressure therapy

Intervention Type DEVICE

Negative pressure therapy at sub atmospheric level

Investigator

Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Splitted course

Group Type EXPERIMENTAL

Negative pressure therapy

Intervention Type DEVICE

Negative pressure therapy at sub atmospheric level

Interventions

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

Negative pressure therapy

Negative pressure therapy at sub atmospheric level

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* They were free from immune deficiency diseases or collagen diseases.
* All patients were homeostasis.
* All patients were medically stable.
* All cases were chronic and did not heal with other treatment methods

Exclusion Criteria

* 1\. Malignancies or receiving radiotherapy. 2. Dermatological diseases. 3. Deep venous thrombosis. 4. Renal failure. 5. Immunosuppressant or anticonvulsants therapies.
Minimum Eligible Age

27 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Badr University

OTHER

Sponsor Role lead

Responsible Party

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

Ashraf Hassan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Banha University

Banhā, , 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.

Ashraf Hassan, phD

Role: CONTACT

+2001067302580

Facility Contacts

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

Ashraf Hassan, PhD

Role: primary

References

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

Mohammed AH, Hamed SA, Abdelghany AI. Comparison between two different protocols of negative pressure therapy for healing of chronic ulcers. J Tissue Viability. 2020 Feb;29(1):37-41. doi: 10.1016/j.jtv.2019.10.003. Epub 2019 Oct 25.

Reference Type DERIVED
PMID: 31677995 (View on PubMed)

Other Identifiers

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

P.T.REC/012/001669

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

NPWTi on Closure of Chronic Pressure Sores
NCT05598398 RECRUITING PHASE4