Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness
Study Details
Study Description
Brief Summary
Background
Chronic non-healing ulcer is a common problem met in clinical practice and represents a burden to the patients. Chronic ulcer lacks growth factors (GFs) to promote the healing process and is frequently followed by superadded infections. Ordinary technique such as wound debridement and regular dressings cannot provide adequate results as these techniques cannot provide the necessary GFs. Platelet-rich plasma (PRP) helps wound healing by releasing various types of GFs.
The aim: to evaluate and compare the efficacy of PRP dressing versus traditional dressings in the treatment of chronic non-healing leg and foot ulcers of different etiology as regard cost of overall treatment and effectiveness (reduction of the size of the ulcer and safety of the technique).
Methods
This prospective study was performed on inpatients and outpatients in general surgery department, Zagazig university hospital from June 2017 to January 2019. Patients were divided randomly into two groups: group A received PRP dressing (N=22, 50%) and group B received conventional ordinary dressing (N=22, 50%).The mean follow-up period was 3 months after the last dressing. Patients treated with PRP at once-weekly interval for a maximum of 12 dressings while patients with ordinary dressings may need one dressing every other day for a maximum of 12 weeks. The reduction in the size of the ulcers (area and volume) in both groups was assessed using centimeter scale and Digital photographs before and after each session and during follow up period.
Keywords: Platelet-rich plasma, ulcers, non-healing, ordinary dressing.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Chronic non-healing ulcer is a common problem met in clinical practice and represents a burden to the patients. Chronic ulcer lacks growth factors (GFs) to promote the healing process and is frequently followed by superadded infections. Ordinary technique such as wound debridement and regular dressings cannot provide adequate results as these techniques cannot provide the necessary GFs. Platelet-rich plasma (PRP) helps wound healing by releasing various types of GFs.
The aim: to evaluate and compare the efficacy of PRP dressing versus traditional dressings in the treatment of chronic non-healing leg and foot ulcers of different etiology as regard cost of overall treatment and effectiveness (reduction of the size of the ulcer and safety of the technique).
Methods
This prospective study was performed on inpatients and outpatients in general surgery department, Zagazig university hospital from June 2017 to January 2019. Patients were divided randomly into two groups: group A received PRP dressing (N=22, 50%) and group B received conventional ordinary dressing (N=22, 50%).The mean follow-up period was 3 months after the last dressing. Patients treated with PRP at once-weekly interval for a maximum of 12 dressings while patients with ordinary dressings may need one dressing every other day for a maximum of 12 weeks. The reduction in the size of the ulcers (area and volume) in both groups was assessed using centimeter scale and Digital photographs before and after each session and during follow up period.
Keywords: Platelet-rich plasma, ulcers, non-healing, ordinary dressing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PRP dressing
|
Procedure: PRP dressing
PRP dressing gel dressings for treatment of chronic ulcer
|
| Experimental: conventional ordinary dressing
|
Procedure: conventional ordinary dressing
conventional ordinary dressing for treatment of chronic ulcer
|
Outcome Measures
Primary Outcome Measures
- change the ulcer size [1.8 years]
healing of the ulcer is assessed using centimeter scale before each dressing
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18-80 years old,
-
males and non-pregnant females,
-
hemoglobin (> 10 gm. /dL),
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post-prandial blood sugar ≤ 140 mg% if diabetic,
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Wounds free of infection (sterile swab) or necrosis.
Exclusion Criteria:
-
malignant ulcer(by biopsy),
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pus discharge/slough,
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ulcer with exposed tendons/ligaments/bone,
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ischemic ulcer (by duplex U/S),
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non-compliant patients ,
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radiation near to the site of ulcer,
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osteomyelitis of underlying bone (x-ray-bone scan) ,
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steroids therapy ,
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thrombocytopenia(< 150,000/dl)
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patients unfit or refuse blood donation from himself or from others.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tamer Alsaied Alnaimy | Zagazig | Sharkia | Egypt | 055 |
Sponsors and Collaborators
- Zagazig University
Investigators
- Study Director: tamer A Alnaimy, MD, faculty of medicine Zagazig university
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- zagazig university 1