Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sharkia
-
Zagazig, Sharkia, Egypt, 055
- Tamer Alsaied Alnaimy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-80 years old,
- males and non-pregnant females,
- hemoglobin (> 10 gm. /dL),
- post-prandial blood sugar ≤ 140 mg% if diabetic,
- Wounds free of infection (sterile swab) or necrosis.
Exclusion Criteria:
- malignant ulcer(by biopsy),
- pus discharge/slough,
- ulcer with exposed tendons/ligaments/bone,
- ischemic ulcer (by duplex U/S),
- non-compliant patients ,
- radiation near to the site of ulcer,
- osteomyelitis of underlying bone (x-ray-bone scan) ,
- steroids therapy ,
- thrombocytopenia(< 150,000/dl)
- patients unfit or refuse blood donation from himself or from others.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: PRP dressing
|
PRP dressing gel dressings for treatment of chronic ulcer
|
|
EXPERIMENTAL: conventional ordinary dressing
|
conventional ordinary dressing for treatment of chronic ulcer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change the ulcer size
Time Frame: 1.8 years
|
healing of the ulcer is assessed using centimeter scale before each dressing
|
1.8 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: tamer A Alnaimy, MD, Faculty of Medicine Zagazig University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- zagazig university 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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