The Effect of 3-Dimensional-Printed Sequential Dual Drug-Releasing Patch on the Capsule Formation Around the Silicone Implant in a Rat Model.

BACKGROUND: Implant-based breast reconstruction is associated with increased risk of early infection and late-stage capsular contracture. OBJECTIVES: We evaluated the feasibility of a dual drug-releasing patch that enabled the controlled delivery of antibiotics and immunosuppressants in a temporally and spatially appropriate manner to the implant site. METHODS: The efficacy of a dual drug-releasing patch, which was 3-dimensional-printed (3D-printed) with tissue-derived biomaterial ink, was evaluated in rats with silicone implants. The groups included implant only (n = 10); implant plus bacterial inoculation (n = 14); implant, bacterial inoculation, and patch loaded with gentamycin placed on the ventral side of the implant (n = 10), and implant, bacterial inoculation, and patch loaded with gentamycin and triamcinolone acetonide (n = 9). Histologic and immunohistochemical analyses were performed 8 weeks after implantation. RESULTS: The 2 drugs were sequentially released from the dual drug-releasing patch and exhibited different release profiles. Compared to the animals with bacterial inoculation, those with the antibiotic-only and the dual drug-releasing patch exhibited thinner capsules and lower myofibroblast activity and inflammation, indicating better tissue integration and less foreign body response. These effects were more pronounced with the dual drug-releasing patch than with the antibiotic-only patch. CONCLUSIONS: The 3D-printed dual drug-releasing patch effectively reduced inflammation and capsule formation in a rat model of silicone breast reconstruction. The beneficial effect of the dual drug-releasing patch was better than that of the antibiotic-only patch, indicating its therapeutic potential as a novel approach to preventing capsular contracture while reducing concerns of systemic side effects.

Topical gel containing Polysiloxanes and hyaluronic acid for skin scar: Formulation design, characterization, and In vivo activity.

BACKGROUND: Scar formation is undesirable both cosmetically and functionally. It shows that silicone gel is effective in preventing and improving scars formed due to a wound formation after injury. OBJECTIVES: This study investigates whether a silicone gel composition based on a novel concept of infusing a biologically active material such as hyaluronic acid and/or salts with various polysiloxane derivatives in a specific proportion to achieve desired viscosity range and their action has a synergistic beneficial effect on skin scar after injury. METHODS: We have developed a topical gel utilizing a combination of emulsifiers, sodium hyaluronate, polysiloxane, and its derivatives. The method of preparation comprises mixing of aqueous phase dispersion and polysiloxanes blend under stirring at room temperature. RESULTS: It results in the formation of a homogenous smooth gel formulation. The developed topical gel formulation was characterized for physicochemical properties, rheology, stability, and anti-scar activity in Wistar rats. It was found that the developed formulation system consists of desirable attributes for skin applications. In vivo investigation of developed polysiloxane gel formulation for anti-scar activity shown promising outcomes compared to marketed product (Kelo-cote scar gel). Furthermore, a histopathology study of healed skin tissues observed the formation of microscopic skin structures compared to the Kelo-cote scar gel. CONCLUSIONS: It indicates that the combination of polysiloxanes and sodium hyaluronate resulting an improvement in anti-scar activity compared to the marketed product containing polysiloxanes alone.

Safety assessment of the prophylactic use of silicone gel sheets (Lady Care®) for the prevention of hypertrophic scars following caesarean section.

This study aimed to investigate the side effects of silicone gel sheet (Lady Care®) and evaluate its prophylactic efficacy in preventing abnormal scarring. Sixty women who underwent caesarean section were recruited from September 2016 to September 2017 in this prospective study. Lady Care® was applied from the 2nd to the 6th postoperative months. Side effects of Lady Care® were evaluated through medical examinations and questionnaires. A plastic surgeon diagnosed abnormal scarring. Pruritus was diagnosed in 25 (47.2%) patients; folliculitis, four (7.5%); dry skin, four (7.5%); contact dermatitis, three (5.7%); wound infection, two (3.8%); and epidermolysis, one (1.9%), albeit with mild severity. Following Lady Care® application, no abnormal scarring and mild hypertrophic scarring was observed in 32 (64.0%) and 18 (36.0%) patients respectively. Of seven patients with pre-existing hypertrophic scars, only two showed hypertrophic scarring after Lady Care® application. Our findings support the safety and prophylactic efficacy of Lady Care®.Impact StatementWhat is already known on this subject? The incidence of abnormal scarring, i.e. keloid or hypertrophic scar formation after caesarean section (CS) is reported to be ∼41%. Abnormal or excessive scar formation can lead to functional limitations, pruritus, pain and cosmetic issues. Studies have also shown a prophylactic effect of the application of silicone materials against the development of hypertrophic and keloid scars, though prohibitive cost and lack of adhesiveness of such gel sheets are known factors limiting their usage.What the results of this study add? The new silicone gel sheet 'Lady Care®' has strong adhesive properties and is consequently not easily peeled off. Furthermore, it is easy to use and economically efficient.What the implications are of these findings for clinical practice and/or further research? This is the first clinical trial on the application of Lady Care® silicone gel sheet for the prevention of CS scarring. Our findings support the safety and prophylactic efficacy of Lady Care®.

Nonsurgical Methods for Penile Augmentation: A Systematic Review.

BACKGROUND: There is no standardized approach for nonsurgical techniques for penile augmentation despite the increase of demand for this intervention. OBJECTIVE: To compare the efficacy and safety between different injection techniques. MATERIALS AND METHODS: On October 8, 2019, a literature search was performed on PubMed, Embase, Ovid, and Cochrane database. All articles describing penile augmentation were included. RESULTS: Thirteen studies were included in this article with a total of 1,311 patients. Five studies were prospective cohort. The most commonly described technique was hyaluronic acid fillers with a total of 4 articles and 205 patients. The mean injected volume ranged from 20 to 40 mL. In all included studies, a minority of patients had side effects, but some had disabling complications. CONCLUSION: There are no defined clinical guidelines for penile augmentation techniques implemented yet. Hyaluronic acid seems to be safe, efficient, and with a high satisfaction score. Further randomized control trials are warranted. EBM LEVEL OF EVIDENCEBASED MEDICINE: 2a.

Topical Scar Treatment Products for Wounds: A Systematic Review.

BACKGROUND: There is an increasing number of over-the-counter topical products that are said to prevent pathologic scar formation and improve scar cosmesis. However, robust clinical data are lacking to substantiate these claims and to guide selection of topical products. OBJECTIVE: To determine the effectiveness of topical scar management products, including silicone gel, Allium cepa onion extract, vitamin E, trolamine, and microporous tape. METHODS AND MATERIALS: A PubMed search (2005-2019) was performed to identify studies of topical scar management products. Randomized controlled trials (RCTs), quasi-RCTs, meta-analyses, and controlled clinical trials were included for analysis. RESULTS: A total of 34 trials were included in this study. Of the 16 trials investigating silicone gel sheets, numerous high-quality RCTs found that silicone gel sheets and silicone gels significantly improved scar outcomes. Only a limited number of studies supported the effectiveness of onion extract, vitamin E, trolamine, and microporous tape products. CONCLUSION: Silicone gel products are an effective noninvasive treatment to prevent formation of pathologic scars and improve mature scars. Further high-quality studies are needed to elucidate the long-term effectiveness of these therapies.

An unusual presentation of localized bullous morphea.

Bullous morphea is a rare variant of localized scleroderma characterized by occasional intermittent blisters. Lichen sclerosus is a chronic inflammatory disease. The coexistence of morphea and lichen sclerosus has been reported in different sites in the same patient and more rarely in the same lesion. We report the case of a 54-year-old woman with an atypical presentation of bullous morphea and some histological features of lichen sclerosus. She presented with a 5-year history of an ulcerated plaque, with a sclerotic and atrophic center and indurated budding margins, localized on the lumbar back. Initially the diagnosis of a squamous cell carcinoma was suggested. A skin biopsy confirmed the diagnosis of bullous morphea and showed some histological features of lichen sclerosus. Topical betamethasone and silicone gel ointment were prescribed leading to complete healing of the ulceration within five months. Our case is unusual because of the atypical clinical presentation, the histological aspect combining signs of bullous morphea and lichen sclerosus, and the favorable results with the use of local corticotherapy and silicone gel.

Adding herbal extracts to silicone gel on post-sternotomy scar: a prospective randomised double-blind study.

OBJECTIVE: Silicone gel has been shown effective in improving healing post-sternotomy scars. It remains to be determined whether adding herbal extracts to the gel would augment the healing effect. METHOD: After median sternotomy, patients were randomised into two groups. Group 1: topical silicone gel plus herbal extract gel (Allium cepa, Centella Asiatica, Aloe vera and Paper Mulberry) and Group 2: silicone gel. Patients were treated for six months. The postoperative scars were assessed at three and six months by plastic surgeons using the Vancouver Scar Scale (VSS) and the patient assessment scar scale. RESULTS: Each group comprised 23 patients (n=46 in total). The VSS was significantly lower in Group 1 than in Group 2 (p=0.018 and p=0.051, respectively). In Group 1, the four differences from baseline were vascularity scores at three and six months (-0.391, p=0.025; -0.435, p=0.013, respectively), and pigmentation scores at three and six months (-0.391, p=0.019; -0.609, p=0.000, respectively). In Group 2, differences from baseline were the pigmentation and vascularity score at six months (-0.6609, p=0.000; -0.348, p=0.046, respectively). CONCLUSION: Our results suggest, post-sternotomy scars trend to have better vascularity and pigmentation when treated with silicone gel plus herbal extracts.

Use of self-adherent silicone sheets in a pediatric burn patient: A case report and instructions for use.

Burns and scalds are relatively common injuries in children. Formation of hypertrophic scars or keloids is feared complications. A 2-year-old girl who spilled a cup of hot coffee onto herself developed widespread hypertrophic scars and beginning keloids on her upper chest, despite application of pressure garments and daily massage with silicone gel. Herein, we describe instructions for use of prolonged continuous 24-hour occlusive application of self-adherent silicone sheets to help mitigate the formation of scar tissue.

Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: a randomized controlled trial.

OBJECTIVE: To determine the effectiveness of silicone and pressure garments (alone and in combination) in children receiving scar management post-burn. DESIGN: Multicentre, parallel-group, randomized controlled trial. SETTING: Hospital outpatient clinics, colocated research centre, or the participant's home. PARTICIPANTS: Children (0-18 years) referred for burn scar management. INTERVENTIONS: Participants were randomized to (1) topical silicone gel only, (2) pressure garment therapy only, or (3) combined topical silicone gel and pressure garment therapy. MAIN MEASURES: Primary outcomes included scar thickness and itch intensity at the primary end-point of six months post-burn injury. The outcome assessor and data analyst were blinded for scar thickness. RESULTS: Participants (N = 153; silicone n = 51, pressure n = 49, combined n = 53) had a median (inter-quartile range) age of 4.9 (1.6, 10.2) years and percent total body surface area burn of 1% (0.5%, 3%) and were 65% male. At six months post-burn injury, intention-to-treat analysis identified thinner scars in the silicone (n = 51 scar sites) compared to the combined group (n = 48 scar sites; mean difference (95% confidence interval) = -0.04 cm (-0.07, -0.00), P = 0.05). No other between-group differences were identified for scar thickness or itch intensity at six months post-burn. CONCLUSION: No difference was identified in the effectiveness of silicone and pressure interventions alone. No benefit to a combined silicone and pressure intervention was identified for the prevention and management of abnormal scarring in children at six months post-burn injury, compared to the silicone or pressure interventions alone.

Comparison of a novel wound dressing vs current clinical practice after laser resurfacing.

BACKGROUND: There are many postprocedure skin care options, but no consensus on the best formulation to optimize healing. Silicone gels have only been used to treat keloids and hypertrophic scars and typically applied after the wound has healed. This study compared the healing response after fractional ablative erbium laser resurfacing with a petrolatum-based ointment and a silicone gel. METHODS: A randomized, open-label, split-face study was performed. Ten subjects underwent Erbium:YAG (Sciton) fractional laser resurfacing. Patients were randomized to apply a petrolatum-based gel or a silicone gel (Stratacel® ; Stratpharma) on either the right or left side of the face. Subjects applied the products twice a day for 7 days and were evaluated in person 7, 30, and 60 days postprocedure. Subjects reported on the overall general aesthetic outcome, perceived pain, itch, and tightness via questionnaires using the Global Aesthetic Improvement Scale and the Wrinkle Severity Rating Scale (WSRS). RESULTS: All subjects healed without complications. By day 60, there was no difference in signs and symptoms of healing between the two different dressing approaches. However, patients treated with the silicone gel had less post-treatment erythema and hyperpigmentation. CONCLUSIONS: A novel silicone gel resulted in reduced signs of erythema and hyperpigmentation postprocedure, without an increase in adverse events. Additionally, the silicone gel dries to form a thin, full contact film and can be covered with sunscreen or cosmetics once dry. This new silicone gel presents a good option for postprocedure care after ablative fractional laser resurfacing.

Role of mechanical and thermal damage in pericapsular inflammatory response to injectable silicone in a rabbit model.

Silicone is used widely for tissue augmentation in humans. However, late complications, such as delayed inflammation and capsular contracture, remain uncharacterized, despite their importance. In the present study, we aimed to determine whether mechanical and thermal damage induce capsular inflammation around a foreign body, and elucidate the biological mechanism underlying this phenomenon. We injected silicone into the subcutaneous layer of the skin of New Zealand white rabbits. The rabbits were divided into two groups: the control group received no treatment; in the experimental group, external force was applied near the injection silicone using high-intensity focused ultrasound (HIFU). Tissues near the injected silicone were harvested from both groups on Days 4, 7, and 30 after HIFU treatment for comparative analysis. Visual and histological examinations showed clearly increased inflammation in the experimental group compared with that in the control group. Furthermore, capsular tissue from the experimental group displayed markedly increased collagen production. Immunofluorescence revealed marked activation of macrophages in the early stages of inflammation (Days 4 and 7 after HIFU treatment), which decreased on Day 30. Assessment of cytokine activation showed significantly increased expression of heat shock protein (HSP)27, HSP60, HSP70, toll-like receptor (TLR)2, TLR4, and interleukin-8 in the experimental group. The expression of transforming growth factor-ß1 did not increase significantly in the experimental group. In conclusion, damage to tissues around the injected silicone induced capsular inflammation. Macrophages and damage-associated molecular pattern molecules were involved in the early stages of inflammation. HSP release activated TLRs, which subsequently activated innate immunity and induced the inflammatory response.

Implant Insertion Time and Incision Length in Breast Augmentation Surgery with the Keller Funnel: Results from a Comparative Study.

BACKGROUND: The Keller funnel is an easy-to-use mechanical device that aids breast implant insertion. This study analyzed implant insertion time and incision length using the Keller funnel versus conventional manual insertion. METHODS: This was an analysis of two cohorts of adult patients undergoing primary breast augmentation with anatomical implants at a single center. In the 'insertion time cohort' (N = 20), implants were inserted with a Keller funnel on one side and manually on the other; follow-up lasted 4 years. In the 'incision length cohort,' both implants were inserted with a Keller funnel (N = 50) or manually (N = 50), with follow-up lasting 12 months. RESULTS: In the insertion time cohort, mean total insertion time (from implant sterile-package opening to final positioning in the pocket) was 35 s (range 13-76 s) with the Keller funnel and 25 s (range 13-43 s) using manual insertion (p = 0.07); the mean time needed to push the implant through the incision was 6 s (range 3-10 s) with the Keller funnel and 16 s (range 13-40 s) with manual insertion (p = 0.04). In the incision length cohort, mean incision length was shorter with the Keller funnel versus manual insertion (35.5 ± 2.1 mm vs. 46.2 ± 3.2 mm; p < 0.001). There were no differences in complications based on insertion method. CONCLUSION: The Keller funnel was associated with decreased incision length and reduced time to push the implant through the incision. This brings potential clinical advantages in minimizing scarring and reducing contamination of the device. LEVEL OF EVIDENCE III: 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 .

[ASSESSMENT OF COMBINED PROPHYLAXIS OF PATHOLOGICAL POSTOPERATIVE FACE SKIN SCARS ACCORDING TO THE VANCOUVER SCALE].

The aim of the research was to study the effectiveness of combined prophylaxis of pathological postoperative face skin scars according to the Vancouver scale. The research involved 29 patients, aging 16-48 years old, who underwent maxillofacial surgery by extraoral accesses with wound primary intention healing. The patients were divided into three groups: the control group, which involved the patients, who after the surgery did not undergo any preventive measures to avoid pathological skin scars development, and two study groups. The patients of the first study group underwent the monotherapy comprising three sessions of extracorporeal shock wave therapy once every 4-5 days. The patients of the second study group underwent three sessions of extracorporeal shock wave therapy once every 4-5 days and local use of silicone gel Strataderm. The Vancouver scale was used to evaluate clinically the effectiveness of the suggested methods of pathological scars development prevention. It involved evaluation (in points) of their consistency, pigmentation, and vascularization. The scars were assessed on the 7th, 30th day after the surgery and in 6 months. Positive results were attained in the patients of both study groups; they were manifested by increased elasticity and compliance of scars, pigmentation becoming of just about surrounding skin natural color, normalization of blood supply to scars, and more rapid disappearance of suture marks. However, these positive signs were more significant in the patients of the second study group that allowed us concluding that combined use of extracorporeal shock wave therapy and local applying of silicone gel Strataderm was advisable.

Can a Cohesive Silicone Bandage Outperform an Adhesive Silicone Gel Sheet in the Treatment of Scars? A Randomized Comparative Trial.

BACKGROUND: The use of topical silicone to treat scars is widespread, and various studies have demonstrated its efficacy to treat scars. A new form of silicone application is a cohesive elastic bandage. The aim of this study was to compare the effects of this bandage versus an adhesive silicone gel sheet on scar elasticity after burn injury. METHODS: A total of 60 patients were enrolled in a randomized, prospective, single-blind, single-center, comparative, parallel-group study. The participants were assigned randomly to one of two treatment arms: one for treatment with a cohesive silicone bandage, and the other with a silicone gel sheet. The color was measured objectively using a Chromameter, and the Cutometer was used to assess vertical elasticity. For subjective assessment of the scars, the authors used the Patient and Observer Scar Assessment Scale. RESULTS: The results reveal that there were no significant differences between the two interventions for most subjective assessments and color measurements. However, the group that received treatment with the cohesive silicone bandage did seem to perform statistically significantly better than the silicone gel sheet group for vertical elasticity and the global score of the Patient and Observer Scar Assessment Scale (observer scale). This was probably because of the unique microstructure of the bandage that ensured a standardized pressure together with uninterrupted contact with the skin. CONCLUSIONS: An elastic cohesive silicone bandage seems to outperform silicone gel sheets for vertical elasticity when treating hypertrophic burn scars. The authors recommend including timing of application and duration of application in future studies. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Acquired Localized Hypertrichosis Following Pressure Garment and/or Silicone Therapy in Burn Patients.

Hypertrichosis is characterized by excessive and abnormal hair growth anywhere on the skin and may develop after prolonged local irritation, such as application of a cast, injury, or a bite. Pressure garment/silicone therapy is often used to prevent hypertrophic scar formation. The adverse effects of gel sheet application include rash, skin breakdown, cessation of scar responsiveness, pruritus, contact dermatitis, and dry skin. We report on 7 burn patients who developed hypertrichosis following application of pressure garment/silicone therapy to prevent hypertrophic scarring.

Does the form of dressings matter?: A comparison of the efficacy in the management of postoperative scars between silicone sheets and silicone gel: a randomized controlled trial.

BACKGROUND: Silicone sheet is commonly used for scar management but hard to apply to irregular surfaces or mobile areas, and difficult to conceal. On the contrary, silicone gel is easy to apply and nearly unnoticeable. Therefore, we conducted this study to compare their effectiveness. METHODS: Patients undergoing horizontal cesarean section were included. Surgical wounds were divided into 2 halves. Patients randomly applied silicone sheets and silicone gel on either side of their wounds for 3 months. The wounds were assessed at 1, 3, 6, and 12 months after surgery. We used the Vancouver Scar Scale (VSS) for an objective evaluation and the visual analog scale (VAS) for a subjective evaluation. RESULTS: There was no statistical significance between the silicone sheet and silicone gel groups with respect to VSS score. The silicone sheet group showed a statistically significant higher VAS score for itch at 1 month follow-up (1.18 ±â€Š2.04 vs 0.35 ±â€Š0.85, P = .01). However, the difference was less than 1 on a scale of 10, so it might not be clinically meaningful. CONCLUSION: Silicone sheet group showed statistically significant worse VAS score in terms of itch. However, the difference was too small to be clinically meaningful.

Topical Agents for Scar Management: Are They Effective?

Scar formation is the body's natural healing response to reestablish dermal integrity following an injury. Excessive scarring, however, can cause significant cosmetic, functional, and psychological problems. A wide variety of topical creams, lotions, and oils are available for scar treatment or wound healing. Sieving through the options and selecting the best option for their patients can be challenging for clinicians, especially given that clinical evidence for many of the active agents in commonly used topical treatments is lacking. The goal of this review is to provide an overview of topical treatments utilized for scar management, including their mechanism of action and evidence of efficacy. As knowledge of the wound healing process is critical to understanding the effects of topical treatments, the pathophysiology of wound healing is also reviewed.

J Drugs Dermatol. 2018;17(4):421-425.

Prospective case-control trial evaluating silicone gel for the treatment of direct brow lift scars.

OBJECTIVE: To evaluate the effectiveness of a topical silicone gel on scars in patients who had undergone bilateral direct brow lift surgery. DESIGN: A randomized double-blind clinical trial with a placebo applied to one scar and topical silicone gel (Dermatix Ultra; Valeant Pharmaceuticals, Laval, Que.) used on the other scar for 2 months. PARTICIPANTS: Twelve patients (for a total of 24 surgical scars evaluated) were included in the study. METHODS: This study was performed in 2 academic hospitals of the University of Montreal in Montreal, Que. (Maisonneuve-Rosemont Hospital and Notre-Dame Hospital). Inclusion criteria were all bilateral direct brow lift surgeries performed in our hospitals. Exclusion criteria included revision surgery, silicone or latex allergy, and wound infection. Each patient received 2 tubes (1 with silicone gel and 1 with placebo) and applied 1 tube to their right brow scar and the other tube to their left brow scar, following the preassigned instructions. The patient and surgeon were blinded to the nature of the substance that was applied to each scar. At each visit, pictures of both scars were taken, and a questionnaire titled "The Patient and Observer Scar Assessment Scale" was filled out by the patient and the surgeon. A grade ranging from 0 to 10 was given on the multiple criteria in the questionnaire, and the sum of these grades was subsequently used for the data analysis. A lower sum was interpreted as improved scarring. At the end of the study, an independent evaluator graded both scars based on pictures. Follow-up visits were held on day 7, week 6, month 3, and month 6 after surgery. A comparison of the experimental and placebo group was performed with nonparametric tests of Wilcoxon signed rank. RESULTS: A total of 24 scars of 12 patients were analyzed (based on 4 follow-up visits). General improvement of scars was reported by the patient, the surgeon, and based on pictures. No statistically significant difference was found between the group treated with silicone gel and the group treated with placebo. All tests had a p value ≥0.08. CONCLUSIONS: We did not find a statistically significant difference between scars treated with silicone gel and scars treated with the placebo after direct brow lift surgery.

Aesthetic reconstruction of retroauricular keloid: Creating a keystone flap from the mastoid-helix area.

Advances in aesthetic rhinoplasty using conchal cartilage grafts have led to a high occurrence of retroauricular keloids. The purpose of this study is to introduce our surgical experiences using a keystone flap in retroauricular keloids following conchal cartilage grafts. The present study is a retrospective review of patients with pathologically confirmed retroauricular keloids following conchal cartilage grafts. These cases were surgically excised and we covered the defect with a keystone flap followed by one-time steroid injection at postoperative day 14 and silicone gel sheeting application for 3 months. Treatment outcome was recorded as recurrence or non-recurrence. In all patients, a follow-up period of minimum 12 months was required. Of these patients, 90.0% had successful treatment of their auricular keloids, whereas 10.0% had recurrences. The postoperative course was uneventful. In conclusion, our aesthetic reconstruction using a keystone flap created from the mastoid-helix area is a useful treatment strategy in terms of retroauricular keloids following conchal cartilage grafts.