Back to resultsComparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers
Primary Purpose
Chronic Ulcers, Negative Pressure Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Negative pressure therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Ulcers
Eligibility Criteria
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.
Sites / Locations
- Banha UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Negative pressure therapy
Investigator
Arm Description
Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Continuous course
Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Splitted course
Outcomes
Primary Outcome Measures
Wound surface area
Wound size
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03701152
Brief Title
Comparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers
Official Title
Comparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ulcers, Negative Pressure Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Negative pressure therapy
Arm Type
Experimental
Arm Description
Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Continuous course
Arm Title
Investigator
Arm Type
Experimental
Arm Description
Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Splitted course
Intervention Type
Device
Intervention Name(s)
Negative pressure therapy
Intervention Description
Negative pressure therapy at sub atmospheric level
Primary Outcome Measure Information:
Title
Wound surface area
Time Frame
8 weeks
Title
Wound size
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
27 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashraf Hassan, phD
Phone
+2001067302580
Email
ashraf.hassan@buc.edu.eg
Facility Information:
Facility Name
Banha University
City
Banha
ZIP/Postal Code
456155
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashraf Hassan, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
31677995
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers
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