Risk Analysis and Study of Post-marketing Adverse Events for Absorbable Sutures / 中国医疗器械杂志

Objective To investigate, analyze, and evaluate the risk data associated with the clinical use of absorbable sutures by retrieving and summarizing information from the databases of the US FDA and CNKI, as well as the adverse event reports related to absorbable sutures from January 2019 to October 2022 within Zhejiang province. The adverse event reports are obtained from both incident locations and monitoring organizations affiliated with the registrant. The aim is to identify the main risk factors associated with the clinical use of absorbable sutures. The key risk factors are potential product quality defects, product design and material selection, clinical selection and application, and postoperative recovery care including patient's self-care. Risk control strategies are further proposed to reduce or minimize the risk of adverse events caused by this product.

Absorbable versus Non-Absorbable Sutures in Paediatric Facial Trauma - A Cosmetic Assessment

Paediatric age group is most vulnerable to trauma. Children often suffer facial injuries. Though many topical skin adhesives and strips are available in the market which have given excellent cosmetic results, deeper injuries especially along the lines of high tension need suturing both with buried and skin sutures. Different variety of sutures are available in the market which are used as per the choice of the surgeon. Children are more apprehensive when it comes to suture removal. So use of absorbable sutures in place of non-absorbable sutures in skin can save the children from this fear factor. MethodsA prospective study was done in the department of plastic surgery from May 2012 to Dec. 2013 with an objective of studying the outcome of plain catgut suture as skin sutures versus non-absorbable skin suture Nylon in facial trauma in the paediatric age group. Chromic catgut was used as buried suture in both groups. All the patients presenting in emergency department with facial trauma with age 10 years or less were included in the study. Skin sutures, where needed removal, were removed on 5th post-operative day followed by follow up on 7th post-operative day, 3rd month and 8th month during which cosmetic assessment of scar was done. 25 patients who presented first in emergency and fulfilled the study criteria were sutured with 5 - 0 chromic catgut buried sutures and skin suture used was 6 - 0 Nylon and this group was labelled group A. Next 25 patients who presented in emergency for suturing were sutured with 5 - 0 chromic catgut as buried and plain catgut as skin suture. This group was labelled as Group B. Cosmetic outcome was assessed on 7th post-operative day, 3rd month and 8th month by using Beusang E cosmetic scar assessment scale based on two parameters which included colour and texture of scar.1 Statistical analysis was done with continuous variables expressed as Mean ± S.D. and categorical variables were expressed as count (percentage). Chi-square was used to compare the categorical variables between groups or Fisher exact test was used. ResultsOn 7th post-operative day follow up, out of 50 patients, 25 patients (50 %) in whom nylon was used as skin suture, 4 patients (16 %) had mismatch of colour. All scars were smooth in texture. In rest 25 patients (50 %) in whom plain catgut was used as a skin suture, 1 (4 %) patient had mismatch of the colour. None of the patients had frank pus in both groups & hypertrophic scar was seen in one patient. On 3rd month follow up, Group A patients with nylon as skin suture, 1 (4 %) patient showed hypertrophic scar whereas in Group B (8 %) patients had hypertrophic scar. On 8th month follow up, both group A & B had colour mismatch of 12% with firm texture of scar in 8% patients. ConclusionsThere is no long-term differences in cosmetic outcomes and complication rates between absorbable catgut suture and commonly used nylon sutures in the repair of facial trauma in paediatric age groups. So, absorbable sutures are acceptable alternative to non-absorbable suture especially in paediatric age group, keeping in mind their apprehensive nature and fear of suture removal.

Absorbable suture anchors for treating femoroacetabular impingement syndrome combined with acetabular labral tears / 中国组织工程研究

BACKGROUND: Metal anchors are not easily accepted by patients as permanent foreign bodies, so bioabsorbable anchors have been gradually applied in orthopedics in recent years. OBJECTIVE: To evaluate the effectiveness of absorbable suture anchors for repairing femoroacetabular impingement syndrome combined with acetabular labral tears. METHODS: Eighty patients with femoroacetabular impingement syndrome combined with acetabular labral tears admitted in Beijing Shijitan Hospital Affiliated to Capital Medical University from February 2014 to February 2016 were selected, and all were treated by absorbable suture anchors under arthroscopy. The Harris hip score, and the Visual Analogue Scale score at baseline, postoperative 1 and 3 months were recorded and compared to assess the effectiveness. The complications and material-host reaction were recorded. The treatment satisfaction was evaluated. The study was approved by the Ethical Committee of Beijing Shijitan Hospital and all patients and their families signed the informed consents. RESULTS AND CONCLUSION: (1) The Harris hip scores at 1 and 3 years postoperatively in 80 patients with femoroacetabular impingement syndrome combined with acetabular labral tears were significantly higher than those at baseline, and the Visual Analogue Scale scores were significantly lower than those at baseline (P 0. 05). (3) None appeared with anchor drop off, cartilage injury or material-host reaction. In summary, the method of absorbable suture anchors under arthroscopy has the advantages of minimal invasion, reliable fixation, simple operation, no metal implants, and significant clinical effect to treat femoroacetabular impingement syndrome combined with acetabular labral tears.

Intraoperative Ultrasound-Guided Percutaneous Repair of a Ruptured Achilles Tendon: A Comparative Study with Open Repair / 대한정형외과학회잡지

PURPOSE: To compare the clinical outcomes of ultrasound-guided percutaneous repair (USPR) and open repair in a ruptured Achilles tendon. MATERIALS AND METHODS: The outcomes of 12 patients with USPR (group A) and 18 patients with open repair (group B) from January 2015 to February 2017 were analyzed retrospectively. The postoperative clinical evaluations were performed using the Arner-Lindholm scale, American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, Achilles tendon total rupture score (ATRS), and visual analogue scale for the overall satisfaction and cosmetic satisfaction with the scar, and the starting time of single heel raises. The complications were also evaluated. RESULTS: The Arner-Lindholm scale, AOFAS ankle-hindfoot score, ATRS, starting time of single heel raises were similar in both groups (all p>0.05). Group A showed a significantly higher overall patient's satisfaction and cosmetic satisfaction in than group B (all p < 0.05). Two cases of Achilles tendon elongation were encountered in group A, and 1 case of re-rupture with deep infection and 1 case of superficial infection were experienced in group B. CONCLUSION: USPR showed good clinical outcomes and high satisfaction as well as a low rate of complications, such as sural nerve injury. Therefore, USPR can be considered as an effective surgical treatment option for Achilles tendon ruptures.

Clinical efficacy of internal fixation with absorbable suture anchors for Sever's disease / 解放军医学杂志

Objective To observe the treatment effect of internal fixation with absorbable suture anchors for calcaneal apophysitis (Sever's disease). Methods The clinical data of 34 Sever's disease patients having received internal fixation with absorbable suture anchors from January 2010 to August 2012 were analyzed retrospectively. Of the 34 patients, 28 were male and 6 were female, aged from 11 to 30 years old (mean 19 years old); 20 with unilateral lesions, 14 with bilateral lesions; 32 suffered inflammatory edema, and 2 with epiphyseal avulsion. All of the patients were diagnosed as suffering from Sever's disease by X-ray combined with clinical symptoms. The sclerotic bone was chiseled off, the attachment site of Achilles tendon was fixed with auxiliary sutures of anchors and then fixed to the bone surface. Different rehabilitation programs were adapted in different periods after operation. The operation time, the site of anchorage and perioperative complications were analyzed, and the therapeutic effects were evaluated by Arner-Lindholm standard. Results All patients were followed up for 2-24 months (mean 9 months). The average operation time for one side was 40.5 minutes. No iatrogenic injury to nerve, vascular or tendon occurred during surgical procedure. No wound infection or foreign-body reaction was found after operation. The therapeutic effects evaluated by Arner-Lindholm standard were excellent in 29 cases, good in 4 and bad in 1 case. Conclusion Absorbable suture anchoring fixation is a reasonable and effective method for the treatment of Sever's disease, and it allows early exercise training for recovery of ankle function. The postoperative functional recovery is found to be satisfactory.

A Case of Anastomotic Stenosis after Arterial Switch Operation / 日本心臓血管外科学会雑誌

Coronary artery obstruction, pulmonary stenosis, aortic valve regurgitation, and enlargement of the neo-aortic root are major complications of arterial switch operation (ASO) for transposition of the great arteries (TGA). Supravalvular aortic stenosis following ASO is rarely reported, and technical factors should be considered as causes in such cases. We report a case of supravalvular aortic stenosis following ASO, in which we speculated that the cause of the stenosis was tissue overgrowth caused by the surgical suture. The patient was a 4-month-old girl with TGA (II) who had undergone ASO on the 12th day after birth. Neo-aortic anastomosis was performed with 7-0 polydioxanone absorbable suture (PDS^®, Ethicon, Somerville, NJ, USA). Transthoracic echocardiography performed 1 month after the surgery showed severe stenosis at the aortic anastomosis which worsened progressively. Therefore, the patient was reoperated 4 months after the previous surgery. The concentrically stenosed aortic wall at the anastomotic site was resected and aortic reanastomosis was performed using an interrupted suture pattern with 7-0 polypropylene (Prolene^®, Ethicon). The histological findings showed proliferation of collagenous fibers around the PDS^® suture. Because of the worsening stenosis over time and the histological findings, we speculated that the tissue overgrowth in reaction to the PDS^® suture was the main cause of the stenosis. Absorbable sutures are useful because they do not leave a foreign substance in the body ; however, the possibility of tissue overgrowth leading to anastomotic stenosis cannot be denied. When using absorbable suture, careful observation is mandatory until the material is completely absorbed.

Treatment of Achilles Tendon Rupture with Absorbable Suture / 대한족부족관절학회지

PURPOSE: The purpose of this study is to report on the result of repairing Achilles tendon using absorbable suture under nerve block. MATERIALS AND METHODS: We retrospectively reviewed 20 patients with acute Achilles tendon rupture who were followed up for at least six months after the operation. We repaired Achilles tendon using two absorbable sutures using the Krackow technique for the proximal stump and the Kessler technique for the distal stump. A programmed postoperative management including non-weight bearing with a short leg cast for four weeks after the operation was applied for all patients. We evaluated clinical results using American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, visual analogue scale (VAS) for satisfaction, range of motion of ankle, functional recovery rate, and the starting time of single heel raise. RESULTS: The mean VAS score for satisfaction and AOFAS score was 9.2 and 93.0, respectively. The affected ankle showed a mean dorsiflexion rate of 90% and plantar-flexion rate of 94% compared to the uninjured side. The single heel raise could start at a mean of 3.5 months after the operation. CONCLUSION: Treatment of Achilles tendon rupture with absorbable suture material using the hybrid suture technique of proximal Krackow and distal Kessler showed sufficient stability and minimal chronic inflammatory reaction.

Surgical Treatment of Achilles Tendon Rupture with Absorbable Suture Materials Only / 대한족부족관절학회지

PURPOSE: To report the clinical results from using absorbable suture materials instead of nonabsorbable materials which have been used more commonly to repair Achilles tendon. MATERIALS AND METHODS: We retrospectively reviewed 21 cases of acute Achilles tendon rupture, treated surgically from 2004 to 2011. Mean follow-up period is 6 months. We repaired Achilles tendon using size 1 Vicryl (Polyglactin 910, Ethicon) for core suture and size 3-0 Vicryl for epitendinous suture. At three months after surgery, we evaluated clinical results with single heel raise height by centimeters, differences of calf circumference and passive range of motion of ankle joint, compared to contralateral side. Also we recorded clinical results with subjective satisfaction grades. RESULTS: At three months after surgery, 20 of 21 patients were able to perform single heel raise over 5 cm in height. Calf circumference differences were less than 1 cm in 12 cases, between 1 cm to 3 cm in 5 cases, more than 3 cm in 4 cases. There was no difference in range of passive motion in 19 cases. All patients satisfied with daily activity except 2 cases with mild discomfort. There was no complication such as rerupture, elongation or infection. CONCLUSION: We experienced excellent clinical results from repairing Achilles tendon with using absorbable suture materials in terms of functional outcomes and patient's satisfaction without any complication. So we may consider using absorbable suture materials instead of nonabsorbable materials to repair Achilles tendon.

Comparison of E. coli Infiltration between New Synthetic Absorbable Sutures

PURPOSE: The proper selection of suture is very important to minimize infection after gastrointestinal anastomosis and closure, which is one of the causes of postoperative complications such as leakage and stricture, etc, in the surgical field. Thus this study focuses on which suture can reduce bacterial infection after surgical operation by comparing in vitro microbial infiltration rates of three synthetic absorbable sutures and that of silk - a relatively absorbable material, using E. coli. METHODS: Four different, sterilized kinds of absorbable sutures were used for two experiments. In experiment 1, the cut-off suture was directly applied to the standard method agar plate and cultured for observation. In experiment 2, the cut-off suture was diluted with 1 ml of tryptic soy broth to be smeared and cultured in the standard method agar plate and counted using a spectrophotometer. RESULTS: The first experiment revealed that bacterial growth was not observed in the monofilament and antibiotic-coated multifilament sutures, while the other sutures of multifilament structure were invaded by bacteria. In the second experiment, counting and averaging the colony from five plates of each test showed that the number of E. coli of monofilament suture, antibiotics-coated polyglactin, polyglactin and silk were 0+/-0, 39.3+/-14.4, 208.6+/-76.6, 59.4+/-26.7, respectively. CONCLUSION: Sutures of monofilament structure are believed to be a relatively safe material that can be used for gastrointestinal anastomosis and closure since it has lower bacterial infiltration rates than sutures of multifilament structure.

Small incision and Absorbable suture for closed Achilles tendon rupture / 中国矫形外科杂志

[Objective]To investigate new methods of the management of closed rupture of Achilles tendon surgery to reduce postoperative skin necrosis.[Method]Small incisions and Absorbable sutures were used to manage 39 cases of closed Achilles tendon rupture,with proximal stump a Bunnell-type suture and remote stump percutaneous repair.[Result]In the 39 cases,three developed slight skin necrosis,of which two healed by changing dressings,the other one healed by debriding and sutureing.Follow-up of 10 months to 36 months was available for 35 cases.According to Arner-Lindholm efficacy evaluation standard,29 cases (82.9%) had excellent result,4(11.4%) had good result,with the good to excellent result of 94.3%.[Conclusion]Small incisions and Absorbable sutures used to manage the closed Achilles tendon rupture,with proximal stump a Bunnell-type suture and remote stump percutaneous repair is an effective and reliable methord for closed Achilles tendon repture,with small invasion,less impact on the skin blood supply,less skin necrosis,less re-rupture reinfection,and faster recovery.

Eyebrow Lift and Malar Fat Lift by Absorbable Suture Fixation with Subperiosteal Dissection

In some blepharochalasis patients, upper blepharoplasty alone is not satisfactory because of narrow distance between eyebrow and eyelash. On that occasion, eyebrow lift is advisable. There are many methods of classical eyebrow lift, such as direct excision, transblepharoplasty approach, anterior hairline technique, and so on. But they are not so effective, have a tendency to recur and also give rise to side effects; unacceptable scar, facial nerve palsy, sensory loss and hematoma, etc. Some patients who have prominent nasolabial folds, are reluctant to perform face lift procedure due to psychologic or economic burden. The authors performed the eyebrow lift procedure separately or simultaneously with face lift or forehead lift. After making 2 or 3 slit incisions, we passed absorbable suture material, 3-0 vicryl, through suborbicularis oculi fat layer. Then it was passed through subperiosteal plane and fixated to the temporalis fascia. When patients complain prominent nasolabial folds, malar fat pad was elevated also in the same manner. This methods is effective and has minimal complication such as facial nerve palsy, scar, sensory loss. Recurrent tendency was rarely observed during follow- up. Dimples were observed at slit incision sites but they disappeared within 2 or 3 weeks. Eyebrow lift and malar fat lift by absorbable suture elevation with subperiosteal dissection is a simple and less morbid. Because of its effectiveness and little side effect or complication, this procedure can be a useful method.

Comparative Study of Tissue Response of Various Suture Materials in Rats / 대한치주과학회지

The purpose of this study is to evaluate histologically the tissue response and resorption of various nonresorbable and resorbable suture materials used for periodontal surgery, using a subcutaneous model on the dorsal surface of the rat. In this study, 10 Sprague-Dawley male rats (mean BW 150gm) were used and the commercially available materials included polyglactin 910, pain gut, nylon, e-PTFE. Animals were sacrificed at 3 days, 1, 2 and 4 weeks after implantation of various nonresorbable and resorbable suture materials. Specimens were prepared with Hematoxylin-Eosin stain for light microscopic evaluation. The results of this study were as follows: 1. Resorption : The resorption of plain gut was showed at 1 week after implantation, was lost their structure and almost resorbed at 4 weeks. The resorption of polyglactin 910 was started at 2 weeks and slowly absorbed untill 4 weeks. 2. Tissue response : Plain gut showed persistent and severe inflammatory reactions from 3 days to 4 weeks. Polyglactin 910, e-PTFE and nylon showed mild inflammatory reactions. Suture material should be biocompatible and be able to be functioned until tissue tensile strength reaches maximum level. In this study, polyglactin 910, nylon and e-PTFE are considered to be proper suture materials for periodontal surgery.

A Comparative Study of Tensile Strength in Vitro and Histologic Reaction on Rabbits between TRISORB Suture Materials and Traditional Suture Materials ( Dexon , Vicryl , Medifit ) / 대한산부인과학회잡지

Objective: Our purpost was to study effectiveness and clinical application of TRISO-RB suture materials and the find the most appropriate coating ingredient. The tensile str-ength and histologic reaction of the TRISORB are compared with those of traditional ma-terials such as Dexon , Vicryl , and Medifit . Study design:In vivo, 20 female rabbits were observed for histologic reaction at di- fferent time intervals after they were implanted with suture material. In vitro, Tensile str- ength was compared among the four suture materials after boiling in distilled water at 80degrees C. It was also compared with the tensile strength in phosphate buffer solution of pH 7.4 at 37degrees C. Results: Histologic reaction was remarkable with Medifit suture material. There was no significant differences among the other suture materials. TRISORB with A coating ingredient showed the least histologic reaction. TRISORB suture materials showed simi- lar tensile strength as those of traditional suture materials in vitro. Conclusion: TRISORB suture material is consists of same polyglycolic acid as trad- itional synthetic absorbable suture materials. It shows no significant differences in vivo and in vitro when compared with other traditional materials. It is considered to be applic- able with humans.