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

Badr University

Status: Unknown

Conditions: Negative Pressure Therapy; Chronic Ulcers

Treatments: Device: Negative pressure therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03701152

P.T.REC/012/001669

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 27 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Negative pressure therapy

Experimental group

Description:

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

Treatment:

Device: Negative pressure therapy

Investigator

Experimental group

Description:

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

Treatment:

Device: Negative pressure therapy