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

October 7, 2018 updated by: Ashraf Hassan, Badr University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Egypt
      • Banha, Egypt, 456155
        • Recruiting
        • Banha University
        • Contact:
          • Ashraf Hassan, PhD

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

27 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Negative pressure therapy
Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Continuous course
Device: Negative pressure therapy
Negative pressure therapy at sub atmospheric level
Experimental: Investigator
Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Splitted course
Device: Negative pressure therapy
Negative pressure therapy at sub atmospheric level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wound surface area
Time Frame: 8 weeks
8 weeks
Wound size
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Badr 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)

January 1, 2018

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 7, 2018

First Submitted That Met QC Criteria

October 7, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 7, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/001669

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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