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ORIGINAL ARTICLE
Year : 2022 | Volume
: 26
| Issue : 2 | Page : 73-76
Autologous platelet-rich fibrin membrane as a wound dressing in the treatment of chronic nonhealing leg ulcers: A prospective study
Amina Asfiya1, Sacchidanand Sarvajnamurthy2, Fardeen Shariff3, Leelavathy Budamakuntala4
1 Department of Dermatology, Yenepoya Medical College, Deralakatte, Mangalore, Karnataka, India
2 Senior Consultant Dermatologist, Sujala Polyclinic and Lab, Bengaluru, Karnataka, India
3 Department of Orthopaedics, Yenepoya Medical College, Deralakatte, Mangalore, Karnataka, India
4 Department of Dermatology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India
Correspondence Address:
Dr. Amina Asfiya
Department of Dermatology, Venereology and Leprosy, Yenepoya Medical College, Deralakatte, Mangalore - 575 016, Karnataka
India
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jdds.jdds_80_20
Background: Chronic nonhealing ulcers of the lower extremity are a cause of morbidity and mortality. The various treatment options available are limited and unsatisfactory. Promoting wound healing with an autologous platelet membrane could be a safe, easy, and inexpensive modality. Purpose: To assess an autologous platelet-rich fibrin (PRF) membrane as a wound dressing in the treatment of chronic nonhealing leg ulcers. Methods: A prospective study enrolled 30 patients with chronic nonhealing leg ulcers. Autologous PRF was applied weekly for 6 weeks. At each visit, the ulcer healing was assessed with wound measurements and photographs. The treatment outcome was defined as a percentage in a change of area and volume of the ulcer at the end of the study period. Results: Thirty patients with chronic nonhealing leg ulcers were treated for 6 weeks. 100% improvement in area of the ulcer was seen in 43% ulcers. The mean percentage of improvement in area of the ulcer was 72%. The mean percentage of improvement in volume of the ulcer was 77%. The mean duration of healing was 5 weeks. Conclusion: This study was limited by the lack of a control group. Autologous PRF may be useful for the treatment of chronic nonhealing leg ulcers which can be done on an outpatient basis with minimum adverse effects.
Keywords: Chronic wound, fibrin, leg ulcers, platelet-derived growth factor, wound healing
Chronic nonhealing leg ulcers are commonly encountered by general surgeons, vascular surgeons, dermatologists, and phlebologists. The treatment of such chronic wounds of the lower extremities presents a therapeutic challenge as many factors contribute to the chronicity of these ulcers. These chronic wounds also are a significant issue for family physicians in their practice. Chronic leg ulcers result from chronic venous insufficiency.[1] Between 2% and 10% of all people with diabetes mellitus suffer from foot ulcers. The incidence rate is 2.2%–5.9% annually.[1] Ulceration around the feet is common in poorly controlled diabetics and can lead to amputation.
Approximately 20% of venous ulcers do not heal after 1 year, and 8% do not heal after 5 years. Annual recurrence is 6%–15% and most ulcers recur more than once.[2] Thus, ulceration of lower limbs is a common complication of a wide spectrum of pathologies that cause a negative impact on patients' quality of life.
Many factors need to be addressed simultaneously when treating chronic wounds, and healing often does not proceed smoothly. Under these conditions, the application of platelet-derived therapies gives ground for optimism. Currently, platelet-rich fibrin (PRF) is being used in reconstructive, cosmetic, orthopedic, cardiovascular, oral maxillofacial, and dermatologic surgery in an attempt to improve tissue healing.[3]
Conventional therapies for the treatment of chronic ulcers may not always be effective, require strict medical care, and may, in some cases, need surgical correction. Promoting wound healing by the application of an autologous platelet membrane may address some of the limitations of other existing options.
The aim of the study was to assess autologous PRF membrane as a wound dressing in the treatment of chronic nonhealing leg ulcers.
MethodsThis is a prospective study involving 30 patients who presented with chronic nonhealing leg ulcers to the skin and STD outpatient department of our hospital. Ethical clearance was obtained before the start of the study from the institutional ethics committee. Thirty cases of chronic nonhealing leg ulcers of various etiologies were selected by convenience sampling. Male and female patients >18 years with a wound duration of at least 6 weeks not responding to conventional therapies for 6 weeks who were willing to participate were included in the study population. We excluded cases with active infection, patients with bleeding disorders, those on anticoagulant medications (aspirin, warfarin, and heparin), uncontrolled sugar levels, and saphenofemoral incompetency.
Written informed consent was taken from the patients before the procedure. A detailed history, including the demographic data - name, age, sex, address, contact number, occupation, and ulcer details such as a history of onset of ulcer, duration, and progression, was recorded. Any treatment in the past for the ulcer and significant past medical and surgical history were queried. Complete blood count, random blood sugar, bleeding time, and clotting time were done. Furthermore, special investigations such as venous/arterial Doppler and pus culture sensitivity were done when indicated.
Selected patients were thoroughly examined for the length, depth, and breadth of the ulcer by “Clock Face Method” described by Sussman using a cotton tip applicator and disposable paper ruler.[4] In the clock face method, 12:00 reference position is toward the head of the body, and measurements are taken from 12:00 to 6:00 and from 9:00 to 3:00. A moistened cotton swab is inserted into the deepest part of the wound bed to measure the depth.
Method of preparation of platelet-rich fibrin
Under aseptic precautions, the blood sample was taken without any anticoagulant in 5-mL tubes. These tubes were then immediately centrifuged at 3000 rpm for 10 min. At the end of centrifugation, three parts were seen in the tube: red blood corpuscles at the bottom, a fibrin clot representing PRF matrix in the middle, and acellular platelet poor plasma (PPP) at the top [Figure 1]a. With the help of a forceps the middle portion containing the fibrin was extracted, and the red blood corpuscles were separated by cutting with a sterile scissor [Figure 1]b. The clot so obtained was squeezed between sterile gauze pads so as to form a fibrin membrane [Figure 1]c and [Figure 1]d. The fibrin membrane obtained was applied over the ulcer after adequate debridement, and a sterile gauze dressing was applied. The dressing was changed on the 3rd day. The procedure was repeated once weekly for 6 weeks and the ulcer healing was assessed. The wound area and volume were calculated by length × width × 0.7854 and length × width × depth × 0.7854, respectively (area and volume of an ellipse, respectively, since the shape of an ulcer can be compared to that of an ellipse). Photographs were taken at every sitting. The treatment outcome was defined as a percentage in change of area and volume of the ulcer and was calculated as initial measurement minus assessment day measurement divided by initial measurement.
Figure 1: (a) PRF obtained at the end of centrifuge. (b) Separating the PRF clot with the help of scissors. (c) Separated PRF clot. (d) PRF ready to be applied. PRF: Platelet-rich fibrinDescription of the centrifuge machine
The centrifuge machine used in the study was a compact laboratory centrifuge manufactured by REMI, Model No: R-4C.
ResultsA total of 30 patients with chronic nonhealing leg ulcers of various causes were treated by autologous PRF. The age of these patients ranged from 19 years to 75 years, with a mean of 55 years (standard deviation [SD] 17).
Among the 30 patients, 26 (87%) were male and 4 (13%) were female. Among the 30 ulcers, trophic ulcers contributed to about 13 (44%) cases, venous ulcer in 9 (30%), traumatic ulcer in 3 (10%), pyoderma gangrenosum (PG) in 3 (10%), diabetic ulcer in 1 (3%), and surgical wound in 1 (3%) [Table 1]. The duration of the ulcer ranged from 2 months to 3 years with a mean duration of 9 months. Seventeen (57%) patients had a duration less than 6 months, 5 (17%) between 6 and 12 months, 7 (23%) between 12 and 24 months, and 1 (3%) between 24 and 36 months.
Table 1: Number of ulcers due to various causes and percentage of improvement of area due to different causesThe sum of mean area of the ulcer decreased from 256 cm2 (SD 9) to 105 cm2 (SD 7) at the end of the 6th sitting and the sum of mean volume of the ulcer decreased from 90 cm3 (SD 6) to 25 cm3 (SD 2) [Figure 2]a and [Figure 2]b.
Figure 2: (a) Trophic ulcer at the first visit. (b) Ulcer healed at the end of the 6th sittingOne hundred percent improvement in area of the ulcer was seen in 13 (43%) ulcers, 81%–90% improvement in 1 ulcer (3%), 71%–80% in 2 (7%), 61%–70% in 3 (10%), 51%–60% in 5 (17%) ulcers, and <50% improvement was seen in 6 (20%) [Table 2]. The mean percentage of improvement in area of the ulcer was 72% [Figure 3]a and [Figure 3]b.
Figure 3: (a) Ulcer at the first visit. (b) Ulcer closed completely at the end of 6 weeksOne hundred percent improvement in the volume of the ulcer was seen in 13 (44%), 91%–100% in 1 (3%), 81%–90% in 3 (10%), 71%–80% in 3 (10%), 61%–70% in 1 (3%), 51%–60% in 5 (17%) ulcer, and <50% improvement was seen in 4 (13%) [Table 2]. The mean percentage of improvement in volume of the ulcer was 77% [Figure 4]a and [Figure 4]b.
Figure 4: (a) Trophic ulcer at the first visit. (b) Ulcer closed completely at the end of follow-upOut of the 13 trophic ulcers (44% of the treated ulcers), 100% improvement was seen in 7 patients (54%) with a mean percentage improvement in area being 82% at the end of 6 sittings. Out of the 9 venous ulcers (30% of the treated ulcers), 100% improvement was seen in 1 ulcer (11%) with a mean percentage improvement in area being 52% at the end of 6 sittings. Out of the remaining 8 ulcers due to other causes (27% of the treated ulcers), 100% improvement was seen in 5 ulcers (63%) which included a diabetic ulcer, 3 traumatic ulcers, and one ulcer of PG. The remaining 3 ulcers included a postsurgical wound (percentage of improvement in area being 23%), the other 2 ulcers were cases of PG (mean percentage improvement in area being 50% at the end of 6 sittings [Table 1].
The mean duration of healing of the ulcers was 5 weeks (SD 2). The average number of sittings per patient was 4. Adverse effects noted were limited to mild infection of the ulcer seen in 3 patients.
DiscussionA chronic nonhealing leg ulcer is defined as the “loss of skin and subcutaneous tissue on the leg or foot, which takes more than 6 weeks to heal.”[5] Chronic leg and foot ulcers occur in many adults with vascular disease or diabetes and are attributed to chronic venous insufficiency, arterial disease, prolonged pressure, or neuropathy.[6] Predominantly, a condition of the elderly, chronic wounds are becoming more prevalent and more difficult to treat and are associated with high treatment costs.[7] Promoting the acceleration of wound healing is highly desirable since the patient quality of life is likely to improve, and the economic impact on the health care system is likely to reduce. Optimum wound healing requires the integration of complex biological and molecular events involved in cell migration, proliferation, extracellular matrix deposition, and remodeling.[8]
PRF, an autologous leukocyte and PRF biomaterial is an innovative advancement in the field of regenerative medicine. PRF as a scaffold in revascularization has several advantages. It can be easily prepared, avoids the biochemical handling of blood and requires only a single centrifugation cycle. It forms an organized fibrin network where the platelets and leukocytes are concentrated leading to the sustained release of various growth factors.[6]
In a study of 12 patients with 17 venous lower-extremity ulcers and nine patients with 13 nonvenous lower-extremity ulcers, the ulcers were treated with autologous PRF matrix membrane (PRFM). The primary endpoints included the incidence and time to complete closure, and the secondary endpoints were the incidence and time to 75% closure. Complete healing was achieved in 66.7% of the patients with venous lower-extremity ulcers in 7.1 weeks (median, 6 weeks) with an average of two applications of PRFM per patient. Among the nonvenous lower extremity ulcer group, 44% of patients treated with PRFM healed completely during the study.[9]
In our study, 13 ulcers (44%) healed completely at the end of 6 weeks. The overall percentage of improvement in the size of the ulcers was 72% (SD 30) at the end of 6 weeks. The mean duration of healing of ulcer was 5 weeks. The average number of applications of PRF per patient was 4.
Another study evaluated the use of platelet-rich plasma in the management of chronic venous ulcers. The mean percentage improvement in the area and volume of the ulcer was 95% (SD 11) and 96% (SD 10), respectively.[10]
ConclusionAutologous PRF is a simple, effective procedure for the treatment of chronic nonhealing leg ulcers. It can be done on an outpatient basis with no apparent risk of allergic reactions.
Our study did not have a control group but gave an estimate on the efficacy of PRF which can be used to power a future study to analyze if PRF dressing is better or worse than other available options.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
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