Therapeutic Profile of Human Umbilical Cord Blood Serum and Autologous Serum Therapies in Treatment of Ocular Surface Disorders: A Pilot Study
Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics. 2023
Purpose: Umbilical cord blood serum (UCBS) is an effective adjunctive treatment along with conventional therapy in ocular surface disorders (OSDs). It aids in rapid ocular surface restoration thereby achieving epithelial integrity, in addition to improvement in subjective and objective parameters. The study aims to compare the efficacy of human umbilical cord blood serum and autologous serum (AS) in treatment of OSD. Methods: A prospective randomized study was conducted on 101 eyes diagnosed with OSD resulting from dry eye disease (DED; n = 40), acute chemical burn (ACB; n = 21), and ocular allergy (OA; n = 40). Randomization was done in Group I, administered with AS, and Group II with UCBS. Outcomes evaluated were visual acuity (VA), eye sensation score (ESS), ocular surface disease index (OSDI), tear break-up time (TBUT), Schirmer's value, Corneal Fluorescein Score, epithelial defect, limbal ischemia, corneal clarity (CC), and improvement in grade of severity. Statistical analysis was done using Wilcoxon signed-rank, Wilcoxon rank sum, Chi-square, and Z-test with a significance level (P ≤ 0.05). Results: In DED, Group II showed significant improvement in VA, ESS, and OSDI by the 7th day, whereas the mean Schirmer, TBUT, and corneal fluorescein staining score improved by 3 months. In ACB, Group II showed improvement in VA, reepithelialization, reduction in limbal ischemia, and CC by 3 months. In OA, Group II showed improvement in ESS by day 7. Conclusion: Human umbilical cord blood serum is more effective than AS in restoring ocular surface.
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.
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.
The impact of tissue glue in wound healing of head and neck patients undergoing neck dissection
European Archives of Oto-Rhino-Laryngology : Official Journal of the European Federation of Oto-Rhino-Laryngological Societies (Eufos) : Affiliated With the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2016;273((1)):245-50.
We investigated the impact of fibrin glue on postoperative drainage amount and duration in head and neck cancer patients who underwent neck dissection. This study was a prospective randomized controlled trial. Patients who were scheduled to undergo neck dissection due to head and neck cancer were eligible for this study. After receiving a detailed explanation, all patients signed an informed consent form before enrollment. Patients were then randomly assigned to the study group (fibrin glue) or control group. In the study group, 2 ml of fibrin glue (Tissucol((R)); Duploject, Baxter AG) was applied on the surface of the surgical wound before closure. Basic demographic data along with tumor-related features, operation-related variables, postoperative drainage amount/duration, postoperative pain, and analgesic usage were collected and analyzed. A total of 15 patients were included in the final analyses, with eight patients in the study group and seven patients in the control group. No significant differences were found between the two groups in age, gender, primary site, clinical N stage, neck dissection levels, perioperative bleeding, postoperative drainage amount/duration, hospitalization duration, and postoperative pain status. The application of 2 ml fibrin glue by the method described herein did not reduce the postoperative drainage amount/duration nor the postoperative pain status in patients who underwent neck dissection.
Evicel versus Tisseel versus sutures for attaching conjunctival autograft in pterygium surgery: a prospective comparative clinical study
PURPOSE To evaluate the outcome of pterygium surgery with conjunctival autograft using Vicryl sutures (Ethicon, NJ), Evicel fibrin glue (Omrix Biopharmaceuticals Ltd, Ramar-Gan, Israel), or Tisseel fibrin glue (Baxter Corp., Mississauga, Canada). DESIGN Prospective, randomized study. PARTICIPANTS Eighty-nine adult patients with primary pterygium. METHODS Patients undergoing pterygium surgery with conjunctival autografting were randomized into groups receiving 10-0 Vicryl sutures, Evicel fibrin glue, or Tisseel fibrin glue. MAIN OUTCOME MEASURES Duration of surgery, level of patient discomfort, visual acuity (VA), surgically induced refractive change (SIRC), complications, and pterygium recurrence. RESULTS Eighty-nine patients participated: 25 in the Vicryl group, 29 in the Evicel group, and 35 in the Tisseel group. The patients' preoperative characteristics were similar in all groups. Fashioning and repositioning of the conjunctival autograft (flap time) was significantly shorter in the fibrin glue groups compared with the Vicryl group: 5.46 minutes for Evicel, 3.6 minutes for Tisseel, and 16.72 minutes for sutures (P < 0.0001). The patient discomfort level during the first postoperative day was significantly lower in the fibrin glue groups compared with the suture group (P = 0.047). There were no significant group differences in the change in logarithm of the minimum angle of resolution VA before surgery and 3 months after surgery (P = 0.7). There were also no significant group differences in the SIRC (P = 0.108). The recurrence rate was 17.24% in the sutures group, 4.17% in the Evicel group, and 0% in the Tisseel group (P = 0.027 sutures vs. fibrin glue groups). Complications included 5 cases of conjunctival graft dislocation in the Evicel group, 1 case of pyogenic granuloma in the Tisseel group, and no complications in the sutures group (P = 0.019 sutures vs. fibrin glue groups). CONCLUSIONS Tisseel fibrin glue for the repositioning of conjunctival autografts in pterygium surgery was associated with a similar functional outcome as that of Vicryl sutures in terms of VA and SIRC. Pterygium recurrence, patient discomfort level, and surgery time were reduced markedly, as were flap dislocation and pterygium recurrence with Tisseel fibrin glue compared with Evicel fibrin glue.
Hemostatic glues in tonsillectomy: a systematic review
OBJECTIVES/HYPOTHESIS The aim of this study was to compare use of hemostatic glues to conventional techniques of intraoperative hemostasis for tonsillectomy. STUDY DESIGN A systematic review of the literature and meta-analysis. METHODS All published prospective controlled trials that compared hemostatic glues to conventional techniques of hemostasis were identified. We performed a meta-analysis of articles comparing fibrin sealant to electrocautery, and of those comparing electrocautery to electrocautery plus fibrin hemostasis. RESULTS Seven studies were identified that made qualifications for review, with a total of 748 patients. Outcome measures were postoperative hemorrhage recorded by investigators, and visual analogue scores of pain for day 1, day 3, and day 10 postoperatively. Use of fibrin sealant was not associated with a reduction in hemorrhage rates following tonsillectomy when compared to electrocautery (pooled relative risk [RR] 0.315; 95% confidence intervals [CI]: 0.047-2.093, 224 patients). No statistical difference in bleeding rate was seen between electrocautery hemostasis alone, compared to electrocautery with fibrin sealant (pooled RR 1.742; 95% CI: 0.433-7.005, 108 patients). No statistically significant difference in pain was identified. CONCLUSIONS Pain and bleeding are significant causes of morbidity post-tonsillectomy. We conclude that there is no significant evidence to support hemostatic glues over current techniques for reducing severity of these outcomes. Consequently, we do not recommended hemostatic glues for routine use in current clinical practice. Studies were generally of low quality and inadequately powered to detect a statistical difference, even when pooled. We advocate further research to facilitate future meta-analysis. LEVEL OF EVIDENCE NA Laryngoscope, 126:236-242, 2016.Copyright © 2015 The American Laryngological, Rhinological and Otological Society, Inc.
The use of a biologic topical haemostatic agent (TachoSil()) for the prevention of postoperative bleeding in patients on antithrombotic therapy undergoing thyroid surgery: a randomised controlled pilot trial
International Journal Of Surgery. 2015;20((Aug)):95-100.
INTRODUCTION Anticoagulants and antiplatelet agents are well-known risk factors for post-operative bleeding. The aim of this prospective, randomized pilot study was to evaluate the effectiveness of a topical haemostatic agent, namely TachoSil, for the prevention of postoperative bleeding in patients on antithrombotic therapy undergoing thyroidectomy. Perioperative management and some distinctive aspects of cervical haematomas were also discussed. METHODS Between January 2012 and May 2014, all patients taking vitamin K antagonists (VKAs) or acetyl salicylic acid (ASA) scheduled for total thyroidectomy were enrolled and randomly allocated to group 1 (standard haemostasis) and group 2 (standard haemostasis + TachoSil). Antithrombotic drugs were always suspended prior to surgery and, when indicated, replaced by bridging anticoagulation with low-molecular-weight heparin. The primary endpoint was the incidence of postoperative cervical haematomas. RESULTS A total of 70 patients were included in the study, representing 8.5% (70/820) of all patients who underwent thyroidectomies in the same period. The overall rate of post-operative cervical haematoma was 7.1% (5/70) and reached 14.8% (4/27) in patients on VKA therapy. All but one occurred more than 24 h after surgery (32nd hour, 8th, 10th, and 13th days). Group 1 (37 patients) and group 2 (33 patients) were well-matched according to clinical and demographic features. Postoperative haematoma was observed in 2/37 patients (5.4%) recruited in the Group 1 and 3/33 patients (9.1%) recruited in the Group 2 (P = 0.661). CONCLUSIONS Patients taking antithrombotic drugs represent a major problem in thyroid surgery. The incidence of bleeding after thyroidectomy is significantly high and the use of TachoSil do not seem effective in preventing its occurrence. However, larger multicenter study is needed to confirm these results.Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
Use of Floseal and effects on wound healing and pain in adults undergoing tonsillectomy: randomised comparison versus electrocautery
European Archives of Oto-Rhino-Laryngology. 2012;269((10):):2247-54.
The objective of this study was to evaluate the effect of FloSeal(®) (FS, Baxter Healthcare, Deerfield, IL, USA) as a haemostatic matrix in comparison to bipolar electrocautery (EC) after tonsillectomy. Eligible patients were adults undergoing cold-knife tonsillectomy because of recurrent tonsillitis, tonsillar hypertrophy, or peritonsillar abscess (more than 3 months previously). Patients were randomly allocated, on a single-blind basis, to either FS or EC for haemostasis during tonsillectomy. Five experienced surgeons judged the handling of FS application using a five-point scale (very good, good, fair, poor, very poor). Postoperative pain scores were evaluated with a visual analogue scale for 20 days, and the duration under pain medication together with the consumption of pain medication was compared. Wound healing was documented on Days 1-5, 10, and 20. A total of 176 patients were enrolled. Overall, 76/77 (98.7%) of surgeon evaluations of FS handling were judged at least good. FS-treated patients showed significantly improved wound healing (less thickness of wound plaques) throughout the postoperative observation period, a trend for less postoperative pain (cumulative pain intensity score; P = 0.074), and a significantly shorter duration of pain-medication use (9.5 vs. 11.6 days; P = 0.014) as well as reduced pain-medication consumption/demand (P = 0.032). No difference in the rate of postoperative haemorrhage was observed between the two treatment groups (4.9% for FS patients, 6.0% for EC patients, P = 0.76). In conclusion, this study demonstrates the easy handling of FS application in tonsillectomy. Its use instead of EC after cold-steel tonsillectomy shows beneficial effects on mucosal recovery, as assessed by a decrease in the thickness of wound coating. Furthermore, FS is associated with a significantly shortened duration of pain-medication use and overall reduction in consumption/demand.
Comparison of purified plant polysaccharide (HemoStase) versus gelatin-thrombin matrix (FloSeal) in controlling bleeding during sinus surgery: a randomized controlled trial
Annals of Otology, Rhinology, and Laryngology. 2011;120((8):):495-8.
OBJECTIVES Purified plant polysaccharide (HemoStase) is a plant-derived hemostatic agent that has not previously been used in sinus surgery. This study was conducted to evaluate the effectiveness of this novel agent in the control of nasal bleeding during endoscopic sinus surgery. The volume of bleeding during endoscopic sinus surgery was hypothesized to not be statistically significantly different between a control group (gelatin-thrombin matrix; FloSeal) and an experimental group (purified plant polysaccharide; HemoStase). METHODS Eighteen patients with a history of chronic rhinosinusitis in whom maximal medical therapy failed who underwent endoscopic sinus surgery were randomized into one of two groups (control FloSeal group or experimental HemoStase group). In the control group, sites in the nose that were actively bleeding during the operation were controlled with FloSeal. In the experimental group, sites in the nose that were actively bleeding during the operation were controlled with HemoStase. The main outcome measure was total operative blood loss. Blood loss was the sum of blood removed by suction during the surgery (recorded in milliliters) and blood on surgical sponges (weighed and converted to milliliters). Statistical analysis was performed with the t-test and the Mann-Whitney U test. RESULTS The amounts of blood loss (mean +/- SEM) were not significantly different between the FloSeal (262 +/- 15 mL) and HemoStase (265 +/- 33 mL) groups (p = 0.93). CONCLUSIONS The results of this study demonstrate the use of a novel product for the control of intraoperative bleeding during endoscopic sinus surgery.
Efficacy of fibrin tissue adhesive in the attachment of autogenous conjuntival graft on primary pterygium surgery Portuguese
Arquivos Brasileiros De Oftalmologia. 2011;74((2):):123-6.
PURPOSE To compare the efficacy of conjunctival autograft surgery with the attachment to the scleral bed using fibrin tissue adhesive or mononylon 10-0 suture after resection of primary pterygium. METHODS A comparative, prospective and randomized clinical trial was performed in 47 eyes of 47 patients with primary medial located pterygium. Group 1 (adhesive) was composed by 21 patients that underwent conjunctival autograft closure with fibrin tissue adhesive (Quixil„¢) and Group 2 (suture) was composed by 26 patients that underwent pterygium surgery with mononylon 10-0 (Ethicon(®)) suture (suture group) after pterygium excision. All surgeries were performed by the same surgeon. Patients were assessed on the preoperative period and on the 1(st), 14(th) and 21(st) postoperative days. They were followed-up with a questionnaire of ocular discomfort and by the surgical time spent, ocular hyperemia, complications and recurrence signals, being the recurrence also evaluated at the 6th postoperative month. Data were submitted to statistical analysis. A value of p<0.005 was considered statistically significant. RESULTS The average surgical time was 19.05 ± 6.12 minutes in group 1 (glue) and 48.15 ± 7.13 minutes in the group 2 (suture) (p<0.001). The ocular discomfort scale analysis showed a lower score in the 1(st) (p<0.005), 7(th) (p<0.001) and 21(th) (p<0.001) postoperative days in group 1. Ocular hyperemia was less intense in all periods of this study in group 1 (p<0.001). Complications were one in each group and both were managed with clinical treatment until the 21(th) postoperative day. There was one recurrence in group 1 and two in group 2 until the 6(th) postoperative month. CONCLUSION In the surgical management of primary pterygium, fibrin tissue adhesive attached the conjunctival autograft, decreased the surgical time and diminished the conjunctival hyperemia and ocular discomfort with similar recurrences on the postoperative period, compared to fixation with mononylon 10.0 suture, proving to be an excellent option for conjunctival autograft attachment in primary pterygium surgery.