Mini-Simple Limbal Epithelial Transplantation Versus Conjunctival Autograft Fixation With Fibrin Glue After Pterygium Excision: A Randomized Controlled Trial
PURPOSE To compare the outcomes between mini-simple limbal epithelial transplantation (mini-SLET) and conjunctival autograft (CAG) fixation with fibrin glue after excision of pterygium. METHODS Ninety-two eyes with primary nasal pterygium were prospectively randomized into a CAG control arm and a mini-SLET study arm. Follow-up examinations were set at the first and third day, at weeks 1, 2, and 4, and at the third and sixth month after surgery. The primary outcome measure was the recurrence rate at 1, 3, and 6 months after surgery, whereas the secondary outcome measures were the intraoperative time, postoperative symptoms, and other complications. RESULTS Eighty-two eyes completed the 6-month follow-up interval. Of the 42 eyes that underwent CAG, 4 (9.5%) exhibited recurrences, whereas only 1 of the 40 eyes (2.5%) treated with mini-SLET had recurrence (P = 0.358). The time taken for surgery in the study group (21.4 minutes) was greater as compared to the control group (15.1 minutes) (P < 0.001). The postoperative median symptom (foreign body sensation, lacrimation, pain, and irritation) score in the CAG group was significantly more for all symptoms on day 1 and day 3; however, on day 7, it was significantly more for pain and irritation only. Except dellen formation (1 in each group), both groups exhibited different other complications, although less in the study group. CONCLUSIONS The study group exhibited a positive trend of less recurrence with reduced postoperative symptoms and other complications. More similar studies are required in future to validate the results.
Autologous blood for conjunctival autograft fixation in primary pterygium surgery: A systematic review and meta-analysis
Current Pharmaceutical Design. 2018
OBJECTIVE To perform a systematic review and meta-analysis of randomized controlled trials comparing the efficacy and complications of autologous blood versus using fibrin glue and surgical sutures for conjunctival autograft fixation in primary pterygium surgery. DESIGN Systematic review with quantitative meta-analysis. METHODS Four authentic databases have been searched using relevant keywords. Eligible studies were obtained, and their data were extracted into an online form. Analysis was done using Review Manager for windows. Dichotomous outcomes were reported as risk ratio, while continuous data were reported as mean difference. RESULTS Seven studies were included in the analysis. Most of included studies were of moderate quality according to Cochrane Risk of Bias assessment tool. There was no difference between the three techniques in recurrence rates (Risk Ratio (RR) 0.80, 95% CI [0.45 to 1.44], p= 0.46). Graft retraction and displacement were more profound in the autologous blood group vs fibrin glue and suture groups (RR 3.22, 95% CI [1.48 to7.02], p= 0.003) and (RR 5.27, 95% CI [2.24 to 12.38], p> 0.001) respectively. In terms of operative time, fibrin glue took shorter while suturing took longer time compared to blood coagulum (Mean Difference (MD) =1.57, 95% CI [0.90, 2.25], p> 0.00001) and (MD -20.47, 95% CI [-38.05 to -2.88], p =0.02). CONCLUSIONS Autologous blood for conjunctival autograft fixation in primary pterygium surgery was associated with lower graft stability than fibrin glue or sutures. However, it did not account for higher recurrence rates than the fibrin glue or sutures. Patient satisfaction and postoperative symptoms are relatively better in the blood coagulum group than the other techniques. The overall quality of evidence is low. Further well designed randomized controlled trials are still needed.
A pilot study evaluating the efficacy and safety of ARTISS human fibrin sealant in external rhinoplasty
Aesthetic Plastic Surgery. 2018;42((2):):590-597.
BACKGROUND Fibrin sealant application in rhytidectomy has previously demonstrated a reduction in adverse events and drainage volume. Fibrin sealant offers multiple potential benefits including decreasing downtime, reducing complication rates, and improving patient satisfaction. In this study, we evaluated the efficacy and safety of ARTISS [fibrin sealant (human)] in external rhinoplasty. METHODS Nine healthy participants between the ages of 18 and 50 seeking external rhinoplasty completed this study. All subjects were randomized into control and treatment groups and then underwent external rhinoplasty, with only the treatment group receiving ARTISS [fibrin sealant (Human)] during surgery. Photographs were taken before surgery and 1 day, 1 week, 1 month, 3 months and 6 months after surgery and used in a blinded assessment of recovery time and esthetic improvement with ecchymosis and satisfaction scales. Subject recovery time, downtime, and self-esteem were evaluated at 1 day, 1 week, 1 month and 6 months after surgery. Recovery time was determined by live assessment of edema and ecchymosis using categorical scales. Subject downtime was assessed through a 30-day patient diary and a downtime questionnaire. Subject self-esteem was evaluated with the Heatherton & Polivy State Self-Esteem Scale. The degree of technical ease with the product was determined by the treating investigator with a 10-cm Visual Analog Scale. RESULTS Patients treated with ARTISS intra-operatively reported significantly higher self-esteem 1 month and 6 months following external rhinoplasty. The ARTISS Easyspray Spray Set was rated as technically easy to administer. CONCLUSION The use of ARTISS fibrin sealant in external rhinoplasties is a safe and easy method and may enhance patient self-esteem. Larger studies are warranted to either verify or challenge the validity of our findings. LEVEL OF EVIDENCE IV 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 .
Aerosolized fibrin sealant is effective for postoperative edema and ecchymosis in open rhinoplasty without osteotomy
Journal of Oral and Maxillofacial Surgery : Official Journal of the American Association of Oral and Maxillofacial Surgeons. 2018;76((9):):2000 e1-2000 e8
PURPOSE Fibrin sealant (FS) was approved as a hemostatic agent, sealant, and adhesive by the Food and Drug Administration in 1998. Our study sought to determine whether FS also reduced edema and pain in rhinoplasty without osteotomy. MATERIALS AND METHODS We conducted a prospective randomized trial involving patients who underwent open rhinoplasty without osteotomy. The patients were randomly assigned to 1 of 2 groups: those treated with aerosolized FS (FS group) and those not treated (control group). The effect of FS on edema of the eyelid, edema of the dorsum and tip of the nose, and periorbital ecchymosis was separately rated postoperatively using a scale of 0 to 4 or 0 to 3. Postoperative pain was evaluated using questionnaires quantified with a visual analog scale. The Mann-Whitney U and Wilcoxon tests were used to compare parameters between the groups. RESULTS A total of 41 patients were included in this study. The FS group (n = 20) consisted of 13 male and 7 female patients with a mean age of 34.8 +/- 5.8 years. The control group (n = 21) consisted of 15 male and 6 female patients with a mean age of 32.4 +/- 4.8 years. There were no statistically significant differences between the 2 groups with respect to age, gender, or combined surgical techniques (P > .05). Aerosolized FS significantly reduced not only ecchymosis and swelling in the periorbital area but also edema of the nasal dorsum (P < .05). CONCLUSIONS Aerosolized FS can be effective for reducing eyelid edema, dorsal edema, and periorbital ecchymosis after open rhinoplasty. FS may serve as an adhesive for minimizing dead space by promoting adherence of the skin flap and as a hemostatic agent in reducing the amount of postoperative bleeding by sealing capillary vessels.
Fibrin tissue adhesive versus nasal packing in endoscopic nasal surgery: a systematic review and meta-analysis
BACKGROUND It has been proposed that fibrin tissue adhesive (FTA) can act as an effective alternative to nasal packing in managing the postoperative symptoms of endoscopic nasal surgery. METHODOLOGY MEDLINE, Embase, Cochrane Library, The Cumulative Index to Nursing and Allied Health Literature and ClinicalTrials.gov were searched for randomised controlled trials comparing FTA with nasal packing in endoscopic nasal surgery. The primary outcome of interest was bleeding; secondary outcomes included pain, nasal obstruction, infection, adhesions and the formation of granulation tissue. All trials underwent a risk of bias assessment, and a meta-analysis was performed using a random effects model. RESULTS 315 studies were found, of which four were eligible for inclusion (n = 152). Bleeding was reported in all, with the meta-analysis favouring the packing group, although this was not significant. Nasal obstruction and granulation severity were significantly lower in the FTA group, however, no difference was noted for the outcomes of pain, infection or adhesions. CONCLUSION Our results indicate minor advantages for using FTA over nasal packing. Unfortunately, the included studies show significant heterogeneity and risk of bias. Based on the available evidence, clinicians must balance the higher cost of FTA against the limited advantages for the patient.
Recurrence rate and graft stability with fibrin glue compared with suture and autologous blood coagulum for conjunctival autograft adherence in pterygium surgery: a meta-analysis
PURPOSE To minimize recurrence and improve graft stability after pterygium surgery, conjunctival autograft adherence is done using fibrin glue (FG) or autologous blood coagulum (ABC). But there are studies that have reported conflicting or inconclusive results. This meta-analysis was conducted to evaluate the postoperative recurrence rate and graft stability after using FG, sutures, and ABC. METHODS MEDLINE, Cochrane databases, and ICTRP were searched and PRISMA guidelines as well as recommended meta-analysis practices were followed. The odds ratio was calculated to estimate the effect size to assess the difference in recurrence and graft stability between the groups. Heterogeneity across the studies was explored using subgroup analyses and quality assessment using the Cochrane risk of bias tool and sensitivity analysis. RESULTS After screening, 30 studies were included for meta-analysis. The random model analysis for recurrence revealed an effect size of 0.44 [95% confidence interval (CI), 0.32-0.60], and subgroup analysis for studies comparing FG and sutures showed an effect size of 0.38 (95% CI, 0.27-0.53). In case of studies comparing FG and ABC, the random model analysis revealed an effect size of 1.01 (95% CI, 0.45-2.26). The random model analysis for graft stability revealed an effect size of 0.87 (95% CI, 0.57-1.31). In subgroup analysis, the random model revealed an effect size of 0.39 (95% CI, 0.17-0.88) indicating significant better graft stability with FG over ABC. CONCLUSIONS This meta-analysis reveals the superiority of FG over sutures as the use of FG can significantly reduce the recurrence rate, but no significant difference in graft stability was found between FG and sutures. No significant difference was found in the recurrence rate between FG and ABC, but graft stability was found to be better with FG compared with ABC.
Comparison of the effect of aerosolized fibrin sealant and biodegradable synthetic polyurethane foam on hemostasis and wound healing after endoscopic sinus surgery: a prospective randomized study
International Forum of Allergy & Rhinology. 2017;7((11):):1089-1094
BACKGROUND Use of absorbable packing materials after functional endoscopic sinus surgery (FESS) is associated with increased patient comfort and a lack of need for packing removal. Different materials may induce different patterns of mucosal healing and hemostasis. This study investigated the effect of fibrin sealant (FS; Tisseel) or biodegradable synthetic polyurethane foam (Nasopore(R) ) packing on hemostasis and wound healing after FESS. METHODS This prospective randomized controlled trial included 35 consecutive patients who underwent bilateral FESS for chronic rhinosinusitis. The patients were randomized to receive FS through aerosol spraying on 1 side and Nasopore packing on the opposite side. They were followed at 1, 2, 4, 8, and 12 weeks after surgery. Endoscopically visible packing material, crusting, adhesion, bleeding, granulation tissue formation, frontal sinus patency, and adverse effects were assessed. Subjective symptoms related to nasal packing were evaluated by using questionnaires quantified with a visual analogue scale. RESULTS No significant differences were found between the FS-treated side and the Nasopore-packed side with respect to postoperative bleeding, adhesion, or frontal sinus patency. However, crusting and granulation were significantly lower in FS-treated nostrils (p < 0.01). The patients' satisfaction and willingness to reuse the material were not significantly different between FS and Nasopore. There were no allergic reactions to either material. CONCLUSION FS and Nasopore were equally successful in achieving hemostasis and patient satisfaction after FESS. However, our results suggest that differential mucosal healing patterns may be induced by alternative absorbable hemostatic materials. FS-treated sides showed more optimal healing patterns than Nasopore-packed sides.
Fibrin sealants in soft-tissue surgery of the head and neck: a systematic review and meta-analysis of randomised controlled trials
Clinical Otolaryngology : Official Journal of Ent-Uk ; Official Journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery. 2017;42((6):):1141-1152
BACKGROUND Fibrin sealants (FS) are commercially available products used in surgical wounds as adjuncts to haemostasis and closure of dead space. The role of FS in soft-tissue head and neck surgery has not been established. OBJECTIVES To assess if FS improves wound related outcomes in patients undergoing soft-tissue surgery of the head and neck anatomical region that would commonly require a drain. TYPE OF REVIEW Systematic review and meta-analysis of randomised controlled trials (RCTs). SEARCH STRATEGY Medline (1946 - 2016), EMBASE (1974 - 2016), PubMed (2016), CENTRAL (2016), ClinicalTrials. gov (2016), WHO International Clinical Trials Registry and Platform (2016), Research Gate (2016). EVALUATION METHOD Two independent reviewers screened and selected studies. Included studies were assessed for risk of bias and data extracted using a predetermined data collection form. RESULTS Of the 421 studies that were screened 11 RCTs met the inclusion criteria. There were 2 RCTs on thyroidectomy, 3 on 'surgery involving neck dissection' (central or lateral), 5 on rhytidectomy and 1 on parotidectomy. There was a tendency for FS to reduce 'mean total drainage volume' (mean difference -26.86ml, 95%CI -43.41 to -10.31, I2 =97%, p=0.001). Sub-group analysis of thyroidectomy (mean difference -36.36ml, 95%CI -72.82 to 0.10, I2 =79%, p=0.05), 'surgery involving neck dissection' (mean difference -33.21ml, 95%CI -70.01 to 3.59, I2 =94%, p=0.08) and rhytidectomy (mean difference -13.79ml, 95%CI -17.57 to -10.01, I2 =0%, p<0.00001) concurred with the overall analysis. There was a suggestion that FS may reduce 'mean retention time of drains' by 1.24 days (95%CI -3.32 to 0.85, I2 =99%, p=0.25) and 'hospital length of stay' by 2.09 days (95% CI -5.18 to 0.99, I2 =97%, p=0.18) but this was not statistically significant. There was also a suggestion that FS may protect against adverse events (RR 0.69, 95%CI 0.35 to 1.38, I2 =0%, p=0.29) and haematoma/seroma formation (RR 0.49, 95%CI 0.22 to 1.07, I2 =0%, p=0.07). CONCLUSIONS There was considerable heterogeneity within the RCTs included in this study thus restricting definitive conclusions. FS has however shown a definite benefit in rhytidectomy and potential benefit in other soft-tissue head and neck surgical procedures. Further pragmatic trials are required particularly in the field of lateral neck dissection. This article is protected by copyright. All rights reserved.
Comparison of fibrin glue and Vicryl sutures in conjunctival autografting for pterygium surgery
Molecular Vision. 2017;23:275-285.
PURPOSE To compare clinical parameters and the tear levels of inflammatory cytokines between pterygium surgery using sutures or fibrin glue. METHODS Fifty-six patients with primary pterygium were divided into the suture group and the glue group, in which the autograft was secured with 10-0 Vicryl sutures and fibrin glue, respectively. A questionnaire, slit-lamp examination, Schirmer test, and visual acuity test were performed in all participants. Real-time quantitative PCR (q-PCR) was used to analyze the expression of genes in pterygium and healthy conjunctival tissues. Based on the qPCR results and literature reports, five inflammatory cytokines, including hepatocyte growth factor (HGF), fibroblast growth factor 2 (FGF2), transforming growth factor-beta1 (TGF-beta1), matrix metalloproteinase 2 (MMP2), and tumor necrosis factor-alpha (TNF-alpha), were selected, and their protein levels were measured with enzyme-linked immunosorbent assay (ELISA) in patient tears before surgery as well as at postoperative day 1, 7, and 30. RESULTS There are 28 patients in either the suture or the glue group. The average duration of surgery was 20.17 +/- 3.23 min for the glue group and 32.42 +/- 4.47 min for the suture group (p = 0.000). Visual acuity in both groups was improved (p = 0.002) after the surgical procedures. There were more symptoms in the suture group than in the glue group at postoperative day 7 (p = 0.002). Postoperative symptoms disappeared in both groups at 1 month after surgery. Recurrence was observed in one case in the glue group and in two cases in the suture group at the 6 month postoperative follow-up (p = 0.714). In comparison to the preoperative levels (4.33 +/- 0.43 ng/ml for the suture group; 4.20 +/- 0.26 ng/ml for the glue group), the levels of TNF-alpha in tears increased in the suture group (5.02 +/- 0.49 ng/ml, p = 0.016) and decreased in the glue group (3.84 +/- 0.35 ng/ml, p = 0.052) on postoperative day 1. The glue treatment induced higher HGF production (4.78 +/- 1.25 ng/ml) than the suture treatment (3.04 +/- 1.18 ng/ml) at postoperative day 1 (p = 0.020). Higher levels of TGF-beta1 in the glue group were detected at postoperative day 1 (3.71 +/- 0.18 ng/ml) and postoperative day 30 (4.50 +/- 0.51 ng/ml), compared to those in the suture group, respectively (2.74 +/- 0.21 ng/ml, p = 0.000 for day 1; 3.36 +/- 0.96 ng/ml, p = 0.017 for postoperative day 30). CONCLUSIONS Fibrin glue is effective and safe for attaching conjunctival autografts with an easy surgical procedure, shortened operating time, and less postoperative discomfort. In the early postoperative period, the protein expression of inflammatory cytokines implicates that fibrin glue may induce accelerated healing and subdued inflammation on the ocular surface compared to sutures.
Comparison of autologous fibrin glue versus nylon sutures for securing conjunctival autografting in pterygium surgery
International Ophthalmology. 2017;38((3):):1219-1224
PURPOSE To compare the safety, operating time, postoperative ocular signs, symptoms, overall patient satisfaction, complications rate and recurrence rate of autologous fibrin glue (AFG) and nylon suturing (NS) for attaching conjunctival autografts in pterygium surgery. METHODS A prospective, randomized, interventional study was performed among 120 patients (120 eyes) with primary pterygium. Superior conjunctival autograft was harvested and transferred on to bare sclera after pterygium excision. For attaching the autograft, AFG (n = 60 eyes) and NS (n = 60 eyes) were used. The patients were followed up for 12 months. The groups were compared for the safety, operative time, postoperative ocular signs, symptoms, overall patient satisfaction, recurrence and complications rate. RESULTS All conjunctival autografts in both groups were successfully attached. The average operating time for the AFG group was significantly shorter (P < 0.001). Postoperative symptoms were fewer for the AFG group than the suture group. After 12 months of follow-up, no recurrence was reported for the AFG group, but 8.3% of patients experienced recurrence in the NS group. CONCLUSIONS Our study demonstrated the superiority of AFG to NS in saving operating time and elimination of recurrence without any complications in pterygium surgery. AFG can obviate the need for suturing and increases the viability of tissue flaps. Additional studies are necessary to determine the long-term effects considering factors such as primary or recurrent status of pterygium, age and sex of patient, dose and duration of treatment for mitomycin C.