Chronic UlcersNCT03701152
Comparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers
A study testing Negative pressure therapy in people with Chronic Ulcers and Negative Pressure Therapy, run by Badr University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 27 to 65 years
- Conditions the study is for
- Chronic Ulcers, Negative Pressure Therapy
- What is being tested?
- Negative pressure therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Malignancies or receiving radiotherapy. 2. Dermatological diseases. 3. Deep venous thrombosis. 4. Renal failure. 5. Immunosuppressant or anticonvulsants therapies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Banha University
Banhā, 456155
Ashraf Hassan, PhD
About this study
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.
Read the 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.
- Conditions
- Chronic Ulcers, Negative Pressure Therapy
- Being tested
- Negative pressure therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure therapyDevice
Negative pressure therapy at sub atmospheric level
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure therapy | Experimental | Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Continuous course Receives: Device: Negative pressure therapy |
| Investigator | Experimental | Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Splitted course Receives: Device: Negative pressure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound surface area
Measured: 8 weeks
Wound size
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jan 2018
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Hassan, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701152
- Sponsor's protocol ID
- P.T.REC/012/001669
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31677995
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers
- ClinicalTrials.gov ID
- NCT03701152
- Acronym / sponsor ID
- P.T.REC/012/001669
- Conditions
- Chronic Ulcers, Negative Pressure Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative pressure therapy | Experimental | Device: Negative pressure therapyNegative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Continuous course |
| Investigator | Experimental | Device: Negative pressure therapyNegative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Splitted course |
Who may qualify
- Ages
- 27 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Malignancies or receiving radiotherapy. 2. Dermatological diseases. 3. Deep venous thrombosis. 4. Renal failure. 5. Immunosuppressant or anticonvulsants therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative pressure therapyNegative pressure therapy at sub atmospheric level | Device | Investigator, Negative pressure therapy |
Primary outcome
Wound surface area
Time frame: 8 weeks
Wound size
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 31677995Mohammed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure therapy in people with Chronic Ulcers and Negative Pressure Therapy, run by Badr University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashraf Hassan, phD (+2001067302580, ashraf.hassan@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound surface area (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.