Polydeoxyribonucleotide Group Research Articles

Polydeoxyribonucleotide and Shock Wave Therapy Sequence Efficacy in Regenerating Immobilized Rabbit Calf Muscles.

This study primarily aimed to investigate the combined effects of polydeoxyribonucleotide (PDRN) and extracorporeal shock wave therapy (ESWT) sequences on the regenerative processes in atrophied animal muscles. Thirty male New Zealand rabbits, aged 12 weeks, were divided into five groups: normal saline (Group 1), PDRN (Group 2), ESWT (Group 3), PDRN injection before ESWT (Group 4), and PDRN injection after ESWT (Group 5). After 2 weeks of cast immobilization, the respective treatments were administered to the atrophied calf muscles. Radial ESWT was performed twice weekly. Calf circumference, tibial nerve compound muscle action potential (CMAP), and gastrocnemius (GCM) muscle thickness after 2 weeks of treatment were evaluated. Histological and immunohistochemical staining, as well as Western blot analysis, were conducted 2 weeks post-treatment. Staining intensity and extent were assessed using semi-quantitative scores. Groups 4 and 5 demonstrated significantly greater calf muscle circumference, GCM muscle thickness, tibial nerve CMAP, and GCM muscle fiber cross-sectional area (type I, type II, and total) than the remaining three groups (p < 0.05), while they did not differ significantly in these parameters. Groups 2 and 3 showed higher values for all the mentioned parameters than Group 1 (p < 0.05). Group 4 had the greatest ratio of vascular endothelial growth factor (VEGF) to platelet endothelial cell adhesion molecule-1 (PECAM-1) in the GCM muscle fibers compared to the other four groups (p < 0.05). Western blot analysis revealed significantly higher expression of angiogenesis cytokines in Groups 4 and 5 than in the other groups (p < 0.05). The combination of ESWT and PDRN injection demonstrated superior regenerative efficacy for atrophied calf muscle tissue in rabbit models compared to these techniques alone or saline. In particular, administering ESWT after PDRN injection yielded the most favorable outcomes in specific parameters.

Protective Effect of Locally Injected Polydeoxyribonucleotide in Ischemic Murine Random Skin Flaps

Background and Objectives This study aimed to investigate the protective effect of polydeoxyribonucleotide (PDRN) against skin flap necrosis in a murine skin flap model.Materials and Method Twenty mice with rectangular skin flaps on the dorsum were randomly divided into the PDRN (n=10) and pentobarbital sodium (PBS) (n=10) injection groups. PDRN (8 mg/kg) was subdermally injected at 12 different points immediately after the operation. After 7 days, the flap perfusions were evaluated using a laser speckle contrast imaging (LSCI) system, and specimens were collected for immunohistochemistry analysis.Results The percentage of survival area relative to the total flap area was significantly higher in the PDRN group (60.87%±7.63%) than in the PBS group (45.23%±10.72%) (&lt;i&gt;p&lt;/i&gt;&lt;0.05). The mean LSCI perfusion signal of the distal part of the skin flap in the PBS group was 0.57±0.12, and that in the PDRN group was 0.74±0.13 (&lt;i&gt;p&lt;/i&gt;&lt;0.05). The PDRN group had a significantly lower interleukin 1 beta expression than the PBS group and higher vascular endothelial growth factor α expression than the PBS group (&lt;i&gt;p&lt;/i&gt;&lt;0.05).Conclusion These findings suggest that subdermally injected PDRN is more effective in enhancing flap survival during necrosis.

The efficacy and safety of polydeoxyribonucleotide for the treatment of knee osteoarthritis: Systematic review and meta-analysis of randomized controlled trials.

Introduction:The purpose of this study was to use meta-analysis techniques to evaluate the efficacy and safety of polydeoxyribonucleotide (PDRN) injections for knee osteoarthritis (OA) treatment.Methods:Multiple comprehensive databases, including MEDLINE, EMBASE, and the Cochrane Library, were searched in November 2018 for studies that compared the effectiveness and safety of intra-articular PDRN injection for the knee joint with hyaluronic acid (HA) injection. Two reviewers independently determined study inclusion and they extracted data using a standardized data extraction form. The predefined primary outcome was Visual Analogue Scale. Secondary outcomes included Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS), and adverse events.Results:Five randomized controlled trials were included in the meta-analysis. After 1 and 2 months, patients in the PDRN group showed significantly better improvement in pain than the HA group (P = .04 and P = .02, respectively). There was no significant difference in pain after 4 months. The pooled analysis showed that no significant differences were seen in function (KOOS and KSS) scores between the PDRN and HA groups (all P > .05) at all time points. There was no significant difference in adverse events between 2 groups (relative risks = 2.15, 95% confidential interval: 0.17–26.67, P = .55).Conclusion:The intra-articular use of PDRN was similar in function to HA, and the pain-relief effect was superior to HA for 2 months post-injection. Therefore, it could be a favorable alternative to HA to treat persistent pain associated with knee OA while avoiding side effects.Level of evidence I

Effect of Polydeoxyribonucleotide on Chondrocutaneous Composite Grafts Survival.

A composite graft is considered the best choice for facial reconstruction because of proper texture, color, and simple surgical techniques. However, due to revascularization by the bridging phenomenon, it has limitations with unpredictable survival rates and can be applied only to small defects. Polydeoxyribonucleotide (PDRN) plays an important role in multiple vascular processes such as angiogenesis via production of a vascular endothelial growth factor and by providing an anti-inflammatory effect by reducing pro-inflammatory cytokines through the adenosine A2 receptor stimulation. Thus, here, we investigated PDRN as a supportive method to improve survival of composite grafts. Chondrocutaneous composite grafts were applied to both ears of 20 New Zealand White rabbits. The grafts were then rotated and returned to their positions to prevent the original blood flow from the base of the grafts. On postoperative days 1, 3, 6, 9, and 12, PDRN was injected intradermally into the experimental group (20 ears) and normal saline was injected into the control group (20 ears) to exclude bias of pressure effect. After 12days, graft survival and cutaneous blood flow were examined under laser speckle contrast imaging. Gross observation indicated that the graft viability in the PDRN group was significantly higher than that in the control group (p < 0.05). Through laser speckle contrast imaging, signal intensity increased from the periphery and progressed centrally with treatment. Our findings suggest that PDRN may increase blood flow around at the base of the graft, restore the perfusion, and improve the survival of the composite grafts. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Polydeoxyribonucleotides Improve Diabetic Wound Healing in Mouse Animal Model for Experimental Validation.

BackgroundWound healing mechanisms is believed to have effects similar to wound healing disorders in diabetic patients, including abnormal inflammatory cells, angiogenesis disorders, and reduced collagen synthesis. Therefore, reestablishment of structural and promoted angiogenesis could be beneficial to promote wound healing process.ObjectiveTherefore, we investigated whether the polydeoxyribonucleotide (PDRN) that was self-production in Korea, could be useful as an intradermal injection for promoting wound healing. Also, we validate for wound healing effect of PDRN using healing-impaired (db/db) mice.MethodsIn this study, we confirmed the effects of PDRN by creating wound models in in vitro and in vivo model. Using an in vitro wound healing assay, we observed that PDRN stimulated closure of wounded monolayers of human fibroblast cells. PDRN (8.25 mg/ml) or phosphate-buffered saline (0.9% NaCl) was injected once daily into the dermis adjacent to the wound for 12 days after skin injury.ResultsTime course observations revealed that mice treated with PDRN showed accelerated wound closure and epidermal and dermal regeneration, enhanced angiogenesis. The wound area and depth decreased at 3, 6, 9, and 12 days after skin injury. Histological evaluation showed an increase of vascular endothelial growth factor, CD31, and collagen fibers in the PDRN group compared with the control group, indicating that PDRN was effective in the treatment of delayed wound healing caused by diabetes.ConclusionThis study suggests that our PDRN has a wound healing effect in transgenic animal models with cells and diabetes through angiogenesis.

Effect of Polydeoxyribonucleotide on Angiogenesis and Wound Healing in an In Vitro Model of Osteoarthritis

Osteoarthritis (OA) is degenerative disease, leading to pain and functional disability. It is reported that polydeoxyribonucleotide (PDRN) is a suitable therapy for OA. However, the therapeutic mechanisms of PDRN in OA are not fully understood. To investigate the effect of PDRN in an in vitro model of OA, interleukin (IL)-1β or phosphate-buffered saline (PBS) was used to treat a human chondrocytic cell line in hypoxic conditions for 24 h (IL-1β group or control group). PDRN was then used to treat IL-1β group cells for 24 h (PDRN group). By Label-Based Human Antibody Array 1000, angiopoietin-2 (ANG-2), platelet-derived growth factor (PDGF), angiostatin, and endostatin, which were related to angiogenesis, were chosen for further validation studies. Quantitative real-time reverse transcription polymerase chain reaction and western blot analysis validated that the levels of PDGF and ANG-2, which were related to pro-angiogenesis, were significantly increased in the PDRN group compared with those in the control group or the IL-1β group. However, the levels of endostatin and angiostatin, which were related in anti-angiogenesis, were significantly decreased in the PDRN group compared with those in the control group or the IL-1β group. In the same manner, vascular endothelial growth factor, which was a mediator of angiogenesis, was significantly increased in the PDRN group compared with those in the control group or the IL-1β group. Furthermore, wound closure was significantly increased in the PDRN group compared with the control group or the IL-1β group by in vitro scratch assay. Moreover, PDRN decreased expression of metalloproteinase 13, as a catabolic factor for OA, but increased expression of aggrecan, which was an anabolic factor for OA. These data suggest that PDRN may promote angiogenesis and wound healing via down-regulation of catabolism and up-regulation of anabolism in an in vitro model of OA.

Clinical evaluation of corneal epithelialization after photorefractive keratectomy in a patient treated with Polydeoxyribonucleotide (PDRN) eye drops: a randomized, double-blind, placebo-controlled trial.

The effect of polydeoxyribonucleotide (PDRN) eye drops vs placebo on corneal epithelial healing after photorefractive keratectomy (PRK) for correction of myopic and myopic-astigmatic defects was evaluated in a randomized, double-blind clinical trial. Primary endpoint for efficacy was the evolution of corneal re-epithelialization. Secondary endpoint was the evaluation of PDRN eye drops tolerability. Sixty eyes were enrolled in the study, randomly allocated into standard therapy plus placebo eye drops (30 eyes), or standard therapy plus PDRN eye drops (30 eyes). Checks were carried out preoperatively and at days 1, 2, 3, and 7 of the follow-up. Six eyes dropped out (four in PDRN group, two in placebo group) for reasons unrelated to the study. On day 2, the disepithelialized area was 8.4 mm2 9.2 (mean SD) in controls and 6.0 mm2 6.8 in PDRN group. On day 3 a complete corneal re-epithelialization was found in 20 out of 26 (77%) eyes of PDRN group and in 17 out of 28 (61%) eyes of placebo group (p<0.05 in percentage terms). On day 7 of follow-up, all eyes appeared to be completely re-epithelialized. The mean score of corneal evaluation on day 3 was 2.9 in PDRN group and 3.75 in control group (p<0.05 between groups). No adverse events occurred during the study. The data of the study have shown that after PRK, PDRN stimulates corneal epithelium regeneration. PDRN eye drops administration four times a day is well tolerated by patients during the re-epithelialization stage. A much larger clinical study should be performed in order to prove the results obtained in this pilot study.(Eur J Ophthalmol 2004; 14: 284-9).

Polydeoxyribonucleotide improves tendon healing following achilles tendon injury in rats

Tendon injuries are major musculoskeletal disorders. Polydeoxyribonucleotide activates the adenosine receptor subtype A2A, resulting in tissue growth and neogenesis. This experimental study confirms that polydeoxyribonucleotide can improve secretion of various growth factors, promote collagen synthesis, and restore tensile strength of the Achilles tendon in a rat model with Achilles tendon injury. Thirty-six male Sprague-Dawley rats, aged 7 weeks, were divided into two groups, and the Achilles tendon was transected and repaired using the modified Kessler's method. In the experimental group (n = 18), the rats received daily intraperitoneal administration of polydeoxyribonucleotide (8 mg/kg/day for 1, 2, or 4 weeks). The control groups received the same amount of normal saline. The rats were euthanized at 1, 2, and 4 weeks, and tissues from the repair site were harvested. The cross-sectional area of the tendon was significantly increased at 2 and 4 weeks in polydeoxyribonucleotide group (p = 0.008 and p = 0.017, respectively). Moreover, tendons in the polydeoxyribonucleotide group were more resistant to mechanical stress at 2 and 4 weeks (p = 0.041 and p = 0.041, respectively). The staining levels of collagen type I in the experimental group were significantly stronger at 2 and 4 weeks (p = 0.026 and p = 0.009, respectively). Furthermore, higher expression levels of fibroblast growth factor, vascular endothelial growth factor, and transforming growth factor β1 were detected in the experimental group at 4 weeks (p = 0.041, p = 0.026, and p = 0.041, respectively). This study confirms that polydeoxyribonucleotide can improve the tensile strength of the rats' Achilles tendon following injury and repair. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:1767-1776, 2018.

Polydeoxyribonucleotide Injection in the Treatment of Chronic Supraspinatus Tendinopathy: A Case-Controlled, Retrospective, Comparative Study With 6-Month Follow-Up

ObjectiveTo determine the efficacy of polydeoxyribonucleotide (PDRN) injection for rotator cuff disease (RCD). DesignCase-controlled, retrospective, comparative study. SettingOutpatient clinic at a university-affiliated tertiary care hospital. ParticipantsPatients (N=106) with chronic nontraumatic refractory RCD who were unresponsive to at least 1 month of conservative treatment: 55 patients received PDRN injection (PDRN group) and 51 continued conservative treatment (control group). InterventionsNot applicable. Main Outcome MeasuresShoulder Pain and Disability Index, score on a visual analog scale of the average shoulder pain level, number of analgesic ingestions per day, isometric strength of shoulder abductor, active range of motion (flexion, abduction, internal rotation, external rotation), and maximal tear size of tendon on ultrasonography at pretreatment and 3 and 6 months postinjection. ResultsThere was no significant difference between the 2 groups in terms of age, sex, shoulder affected, duration of symptoms, and ultrasonographic findings at pretreatment. Compared with the control group, the treatment group showed a significant improvement in Shoulder Pain and Disability Index, visual analog scale score, and number of analgesic ingestions per day. However, there was no difference in isometric strength, active range of motion, and maximal tear size of tendon. No adverse events were reported. ConclusionsTo our knowledge, this is the first study to assess the efficacy of PDRN injection for patients with RCD. The PDRN injection group showed improvement in pain and subjective disability in patients with RCD and continued to show improvement for 3 months thereafter; the PDRN injection can be an optional treatment for patients with chronic RCD who show no response to other treatments.

Regenerative effect of the polydeoxyribonucleotide after sciatic nerve transection in mouse

Factors that have effects on postoperative nerve regeneration are surgery period, maneuver and the use of material that promotes nerve regeneration. Of various materials that promote nerve regeneration, vascular endothelial growth factor (VEGF) is known as cytokine that plays an important role in regenerating not only vessels but also nerves. Polydeoxyribonucleotide (PDRN) promotes the synthesis of VEGF. Thus, assuming that PDRN has the effect of peripheral nerve regeneration, mice were classified into a group with PDRN being administered, a group with VEGF being administered, and a group with nothing administered. Placentex® (PDRN) and VEGF were used, and 40 male mice were used. Then, the mice were classified into two test groups with Placentex® and VEGF injection, and the control group with NaCl 0.9%. After 2 and 4 weeks, the mice were killed and their histological examination was conducted through electron microscope. It revealed that each group was insignificantly different in terms of all comparative items, but the finding after 4 weeks revealed that the test group with PDRN and VEGF showed a statistically significant effect of promoting nerve regeneration. Further, all histological examinations found that the group with PDRN and VEGF promoted nerve regeneration. Regarding the period, the group with VEGF, compared to the PDRN group, showed a better result, but the difference proved to be statistically insignificant. It was confirmed that PDRN had the effect of promoting nerve regeneration; thus PDRN can help restore peripheral nerve damage, caused by trauma and surgery, and promote the prognosis.

The Effect of Polydeoxyribonucleotide on Ischemic Rat Skin Flap Survival.

Polydeoxyribonucleotide (PDRN) has multiple vascular actions such as angiogenesis and production of a vascular endothelial growth factor (VEGF) through the adenosine A2 receptor stimulation. We applied PDRN on the ischemic flap of rat back and investigated whether it enhances the skin flap survival. A total of 28 Sprague-Dawley rats were divided into 3 groups, namely, PDRN group, control group 1 (no treatment), and group 2 (phosphate-buffered saline injection). On the distally based flap of 3 × 9 cm in size, it was subdermally injected with PDRN or phosphate-buffered saline, which were administered 48 hours prior and immediately after flap elevation. The PDRN group was daily maintained by intraperitoneal administration of PDRN from the postoperative 1st day to 10th day. The mean survival rates of flap in PDRN group [79.5% (6.3%)] are significantly larger than control groups [1, 53.0% (6.9%); 2, 51.7% (6.7%)]. Serial measurements of blood perfusion also showed that the blood flux was significantly increased in almost part of the flap on the 10 days after PDRN injection. The number of CD31 positively stained vessels and expression of VEGF protein were significantly higher in the PDRN group. We propose that administration of PDRN into the ischemic skin flaps increased blood flux to the flap, VEGF expression, and number of capillaries, thereby improving the rat skin flap survival.

Effectiveness of polydeoxyribonucleotide injection versus normal saline injection for treatment of chronic plantar fasciitis: a prospective randomised clinical trial.

Polydeoxyribonucleotide (PDRN) has been used for the treatment of chronic tendinosis. This prospective randomised study was conducted to evaluate the efficacy and complications of PDRN injection for treatment of plantar fasciitis. Forty patients with a clinical diagnosis of plantar fasciitis were randomly allocated to PDRN injection (PDRN group, n = 20) or normal saline injection (placebo group, n = 20). Injections were performed weekly for three weeks. Clinical evaluations were done at baseline and four and 12 weeks after treatment began using the visual analogue scale (VAS) for foot pain and Manchester-Oxford Foot Questionnaire (MOXFQ). We also monitored the complications in both groups at one, two, four and 12 weeks after initial treatment. The PDRN group achieved a significant improvement in VAS and MOXFQ scores at four weeks after treatment, and this improvement continued until 12 weeks after treatment. On the other hand, the placebo group did not achieve a significant improvement in the VAS or MOXFQ scores at four or 12 weeks. The initial VAS and MOXFQ scores of the PDRN group were not significantly different from those of the placebo group. At four weeks after treatment, the VAS and MOXFQ scores of the PDRN group were better than those of the placebo group, but the difference was not statistically significant. At 12 weeks after treatment, the VAS and MOXFQ scores of the PDRN group were significantly better than those of the placebo group. We noticed no injection-related complications, such as itching, urticaria, redness or infection signs around the injection site in either group. PDRN injection is an effective and safe treatment option and may be considered for plantar fasciitis.

Corrigenda

Foot ulcer is the principal cause of hospitalization for patients with diabetes. Polydeoxyribonucleotide (PDRN), an adenosine A2A receptor agonist, improves wound healing in diabetic mice. The aim of this study was to evaluate the effect of PDRN on chronic ulcer healing in patients with diabetes. This randomized, double-blind, placebo-controlled trial, involved two medical centers in Italy. Patients with diabetes showing hard-to-heal ulcers (Wagner grade 1 or 2) were randomly assigned to receive placebo (n = 106) or PDRN (n = 110). The treatments (PDRN and placebo) were performed for 8 weeks by intramuscular and perilesional route [corrected]. The primary outcome was complete ulcer healing. Secondary outcomes were the days needed to complete wound closure and the reepithelialization of wound surface (as percentage of the original area). After 8 weeks, 91 placebo and 101 PDRN subjects completed the study. Complete healing was achieved in 18.9% [95% confidence interval (CI) 11.4-26.3] of placebo and in 37.3% (95% CI 28.2-46.3) of PDRN-treated patients (P = .0027). After 8 weeks, PDRN increased the closure of foot ulcers in diabetic subjects (hazard ratio 2.20; 95% CI 1.29-3.75; P = .004). The median time to complete wound healing was 49 days for placebo (range 28-56 d) and 30 days for PDRN-treated subjects (range 14-56 d; P = .0027). The median epithelialized area of the ulcers (expressed as percentage) was 49.3% in the placebo and 82.2% in the PDRN group (P < .001). PDRN facilitates the healing of Wagner 1 or 2 diabetic foot ulcers.

The Effects of Polydeoxyribonucleotide on the Survival of Random Pattern Skin Flaps in Rats

BackgroundPartial or complete necrosis of a skin flap is a common problem. Polydeoxyribonucleotide (PDRN) can be extracted from trout sperm and used as a tissue repair agent. The aim of this study was to investigate whether PDRN could improve the survival of random pattern skin flaps in rats.MethodsTwenty-two male Sprague-Dawley rats were randomly divided into two groups: the PDRN treatment group (n=11) and the control group (n=11). Caudally pedicled random pattern skin flaps were elevated on their dorsal skin and resutured. The treatment group received daily intraperitoneal administration of PDRN (8 mg/kg/day), and the control group received fluid vehicle (NaCl 0.9%, 8 mg/kg/day) from day 0 to day 6. On day 7, the flap survival was evaluated and the harvested tissue surrounding the demarcation line of the necrotic area was stained with H&E, anti-rat vascular endothelial cell growth factor (VEGF) antibody, and PECAM-1/CD31 antibody.ResultsThe average necrotic area of the flap in the PDRN group was significantly smaller when compared with that of the control group. Histologic and immunohistochemical evaluation showed that granulation thickness score and VEGF-positive staining cells were marked higher in the PDRN group than in the control group. PECAM-1/CD31-positive microvascular densities were significantly higher in the PDRN group when compared with the control group.ConclusionsThis study confirms that PDRN improves the survival of random pattern skin flaps in rats. These results may represent a new therapeutic approach to enhancing flap viability and achieving faster wound repair.

Clinical Evaluation of Corneal Epithelialization after Photorefractive Keratectomy in Patients Treated with Polydeoxyribonucleotide (PDRN) Eye Drops: A Randomized, Double-blind, Placebo-controlled Trial

The effect of polydeoxyribonucleotide (PDRN) eye drops vs placebo on corneal epithelial healing after photorefractive keratectomy (PRK) for correction of myopic and myopic-astigmatic defects was evaluated in a randomized, double-blind clinical trial. Primary endpoint for efficacy was the evolution of corneal re-epithelialization. Secondary endpoint was the evaluation of PDRN eye drops tolerability. Sixty eyes were enrolled in the study, randomly allocated into standard therapy plus placebo eye drops (30 eyes), or standard therapy plus PDRN eye drops (30 eyes). Checks were carried out preoperatively and at days 1, 2, 3, and 7 of the follow-up. Six eyes dropped out (four in PDRN group, two in placebo group) for reasons unrelated to the study. On day 2, the disepithelialized area was 8.4 mm2+/-9.2 (mean+/-SD) in controls and 6.0 mm2+/-6.8 in PDRN group. On day 3 a complete corneal re-epithelialization was found in 20 out of 26 (77%) eyes of PDRN group and in 17 out of 28 (61%) eyes of placebo group (p<0.05 in percentage terms). On day 7 of follow-up, all eyes appeared to be completely re-epithelialized. The mean score of corneal evaluation on day 3 was 2.9 in PDRN group and 3.75 in control group (p<0.05 between groups). No adverse events occurred during the study. The data of the study have shown that after PRK, PDRN stimulates corneal epithelium regeneration. PDRN eye drops administration four times a day is well tolerated by patients during the re-epithelialization stage. A much larger clinical study should be performed in order to prove the results obtained in this pilot study.

Clinical Evaluation of the Trophic Effect of Polydeoxyribonucleotide (PDRN) in Patients Undergoing Skin Explants. A Pilot Study

SUMMARYObjective: The purpose of this double-blind, randomised, placebo-controlled study was to assess the effects of intramuscular and subcutaneous PDRN in favouring the wound-healing process in donor sites of grafts.Methods: 26 adult patients of both sexes (15 males and 11 females; mean age: 68.2 ± 16.1 years) subjected to skin explants due to plastic surgery were eligible to participate in this double-blind, placebo-controlled study. Patients were randomly allocated into the PDRN group (14 subjects) or the placebo group (12 subjects). PDRN (5625 mg/vial) or placebo were administered by the intramuscular route once daily, associated with a subcutaneous administration of the same dosage form (2 vials every 3 days) for 10 consecutive days.The primary end point for efficacy was the evolution of wound healing in donor sites, which was evaluated measuring wound surface area and then calculating percentage re-epithelialisation. Secondary end points were local subjective symptoms, such as pain and itching, and objective signs such as perilesional erythema and blisters. Signs and symptoms were quantified through an analogue scale.Results: At day 7 of the treatment period, the difference in percentage of re-epithelialisation was statistically significant (p < 0.008) in; favour of the PDRN group. At the end of the observational period, between-group comparison demonstrated that patients treated: with PDRN had a more prompt trophic effect.No adverse events were reported during the trial.Conclusions: The findings of our study demonstrated that PDRN is able to modify positively the repair processes in donor sites of autologous skin grafts. This could improve the clinical outcome and decrease the need for additional therapies or hospital stay.

Clinical Evaluation of the Trophic Effect of Polydeoxyribonucleotide (PDRN) in Patients Undergoing Skin Explants. A Pilot Study

SUMMARYObjective: The purpose of this double-blind, randomised, placebo-controlled study was to assess the effects of intramuscular and subcutaneous PDRN in favouring the wound-healing process in donor sites of grafts.Methods: 26 adult patients of both sexes (15 males and 11 females; mean age: 68.2 ± 16.1 years) subjected to skin explants due to plastic surgery were eligible to participate in this double-blind, placebo-controlled study. Patients were randomly allocated into the PDRN group (14 subjects) or the placebo group (12 subjects). PDRN (5625 mg/vial) or placebo were administered by the intramuscular route once daily, associated with a subcutaneous administration of the same dosage form (2 vials every 3 days) for 10 consecutive days.The primary end point for efficacy was the evolution of wound healing in donor sites, which was evaluated measuring wound surface area and then calculating percentage re-epithelialisation. Secondary end points were local subjective symptoms, such as pain and itching, and objective signs such as perilesional erythema and blisters. Signs and symptoms were quantified through an analogue scale.Results: At day 7 of the treatment period, the difference in percentage of re-epithelialisation was statistically significant (p < 0.008) in; favour of the PDRN group. At the end of the observational period, between-group comparison demonstrated that patients treated: with PDRN had a more prompt trophic effect.No adverse events were reported during the trial.Conclusions: The findings of our study demonstrated that PDRN is able to modify positively the repair processes in donor sites of autologous skin grafts. This could improve the clinical outcome and decrease the need for additional therapies or hospital stay.