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

Negative Pressure Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03701152
• Other study ID #: P.T.REC/012/001669
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: October 2018
• Source: Badr University
• Contact: Ashraf Hassan, phD
• Phone: +2001067302580
• Email: ashraf.hassan[@]buc.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. NPWT eases debridement as well as promoting healing of different types of wounds.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 27 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Ulcers
• Negative Pressure Therapy
• Ulcer

Intervention

Device:
• Negative pressure therapy
Negative pressure therapy at sub atmospheric level

Locations

Country	Name	City	State
Egypt	Banha University	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound surface area		8 weeks
Primary	Wound size		8 weeks