Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

All enrolled patients will accept bronchial sleeve resection and lymphadenectomy. If fast-frozen pathology of the resection margin of bronchus confirms negative, We will use the absorbable sutures for bronchial anastomosis.

All enrolled patients will accept bronchial sleeve resection and lymphadenectomy. If fast-frozen pathology of the resection margin of bronchus confirms negative, We will use the non-absorbable sutures for bronchial anastomosis.

Absorbable Suture

Non-absorbable Suture

Zhe Wu, PhD

Wenjie Jiao, PhD

Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. There are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem.

Lung cancer has been one of the most serious life-threatening diseases of human society. It has the highest morbidity and mortality worldwide among all the malignant tumors. Although the treatment of lung cancer is increasingly diverse, surgical resection is still the mainstay.

Pneumonectomy, as a surgical approach for central primary lung cancer, is very harmful to patients. Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. Both absorbable and non-absorbable suture are used for it. But there are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem.

The investigator sets incidence rate of anastomotic complications as the primary endpoint. According to the calculation, a total of 40 patients will be enrolled (each group has 20 patients).

Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection

Comparison of Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection

such as anastomotic stenosis, anastomotic fistula and so on

The Affiliated Hospital of Qingdao University

Professor

Wounds and Injuries

Symptoms and General Pathology

Cicatrix

wound closure using polyglactin 910 (Vicryl®, Ethicon, Johnson and Johnson Ltd., NJ, USA) and polypropylene (Prolene®, Ethicon)

wound closure using polydioxanone (StratafixTM Spiral PDS® Plus) and combination of 2-octyl cyanoacrylate and polyester mesh (Dermabond Prineo®)

We prospectively analyze clinical outcome data from 30 subjects who perform multi-layer wound closure using polyglactin 910 and polypropylene, and polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh following excision of giant benign tumors.

multi-layer wound closure

Kyung-Chul Moon, MD, PhD

Due to the rise in the incidence of giant benign tumors such as lipoma, excision of benign tumors on body have been performed by plastic surgeons. After excision of giant benign tumors, efforts should be include with a goal of achieving optimal cosmetic outcomes after subcutaneous and dermal sutures may be important to improve scar quality because suture methods might influence the final aesthetic outcome. Various absorbable suture materials have been used for tension-relieving deep sutures. Subcutaneous and dermal sutures using Polygalctin 910 (Vicryl®, Ethicon, Johnson and Johnson Ltd.), which is absorbable, synthetic, braided suture composed of a copolymer made from 90% glycolide and 10% L-lactide or polydioxanone (PDS®, Ethicon), which is composed of polyester and p-dioxanone with skin suture using polypropylene (Prolene®, Ethicon) have been commonly used after excision of tumors.

Although these sutures are particularly useful where combination of absorbable suture and extended wound support for up to six weeks is desirable, strong and secure skin sutures may be needed to improve scar quality following excision of tumors on back and abdomen due to their thick skins. However, increased wound closure times are their drawbacks. To overcome these drawbacks, a new subcutaneous suture material composed of polydioxanone, StratafixTM Spiral PDS II® and a new skin suture material using combination of 2-octyl cyanoacrylate and polyester mesh (Dermabond Prineo®, Ethicon) have been developed and skin sutures using combination of these two materials may be an alternative suture method to decrease wound closure times and improve scar quality for better wound closure with high-tension closure, favorable and encouraging results compared to traditional suture methods.

Although polyglactin 910, polydioxanone, polypropylene, and combination of 2-octyl cyanoacrylate and polyester mesh have been used in general surgery and neurosurgery, no studies on the clinical outcomes, specifically on scar quality after excision of tumors have been reported in plastic surgery. Therefore, the purpose of this study is to compare clinical outcomes associated with scar quality between the use of polyglactin 910 and polypropylene suture, and polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh for multi-layer wound closure following excision of giant benign tumors.

We prospectively analyze clinical outcome data from 30 subjects who perform multi-layer wound closure using polyglactin 910 (Vicryl®, Ethicon, Johnson and Johnson Ltd., NJ, USA) and polypropylene (Prolene®, Ethicon), and polydioxanone (StratafixTM Spiral PDS® Plus) and combination of 2-octyl cyanoacrylate and polyester mesh (Dermabond Prineo®) following excision of giant benign tumors. Patients are randomized into two groups: one sutured by polyglactin 910 and polypropylene and the other group sutured by polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh. For a group sutured by polyglactin 910 and polypropylene, deep dermal layer will be sutured by polyglactin 910 and polypropylene will be used for suture of superficial dermis and epidermis. For the other group sutured by polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh, deep dermal layer will be sutured by polydioxanone and polyester mesh will be applied for approximation of superficial dermal layer and epidermis.

A computer-generated list, created using random permuted blocks of 6, that is stratified by hospital will be used for randomization. The allocation configuration will be generated and concealed until interventions will be assigned by a secretary not involved in this trial. Patients with benign tumors greater than 20cm2 (expected scar length more than 3cm) will be included in this study. A Sonography or magnetic resonance imaging scan with millimeter slices will be performed to measure the size of the tumors.

Based on previous studies, the number of subjects was calculated in this study. The weighted scar quality was 2.85 ± 0.57 in one group and 1.96 ± 0.58 in the other group. The following values were used to calculate the number of subjects: Type I error (α) = 5%, power of test = 95%. Independent t-test was used to calculate sample size and differences between two independent means of two groups were used for calculation of sample size. Actual power was 0.954 and the calculation result of the sample size in each group was 10. Considering a drop-out rate of broadly 30%, the number of subjects in each group was 14.3 (=10/(1-0.30)) and a sample size of 30 (=15 × 2) randomly assigned subjects was required.

Differences between the randomized groups will be tested for statistical significance using the Pearson's Chi-Square test for categorical variables. For continuous variables, the independent t-test or Wilkoxon rank-sum test for independent samples will be used for not normally distributed variables. Both intention-to-test (ITT) and per-protocol (PP) analyses will be performed. The median operative time to complete wound closure was also estimated using the Kaplan-Meier method. A P-value \< 0.05 is considered statistically significant. All statistical analyses are performed using SPSS for Windows, version 12.0 (SPSS, Inc, Chicago, IL).

A Comparative Study of Scar Quality and Safety According to Suture Materials Following Excision of Benign Tumors

Clinical Outcomes Associated With the Use of Polyglactin 910 (Vicryl®) and Polypropylene (Prolene®) Suture, and Polydioxanone (StratafixTM Spiral PDS® Plus) and Combination of 2-Octyl Cyanoacrylate and Polyester Mesh (Dermabond Prineo®) for Multi-Layer Wound Closure Following Excision of Giant Benign Tumors

suture material exposure, hemorrhage, surgical site infection, wound infection, skin necrosis, wound dehiscence, seroma rates, and hyper- or hypoesthesia

aesthetic outcome as assessed by the overall impression

Johnson and Johnson Medical Korea Ltd

Korea University Guro Hospital

Clinical Assistant Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Endometriosis

Cysts

Ovarian Cysts

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Coagulants

All Drugs and Chemicals

Hemostatics

Thrombin

Fibrin Tissue Adhesive

During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL® Fibrin Sealant, Ethicon, USA), which consist of thrombin and coagulating proteins, mainly fibrinogen and fibronectin. If hemostasis is not fulfilled enough by using it, a additional intervention such as electrocoagulation with bipolar forceps and barbed suture is required to stop bleeding.

During operation, barbed suture will be applied to the inner surface of ovarian parenchyme where ovarian endometriosis was attached. In this group, if bleeding is continued after suturing, additional electrocoagulation with bipolar forceps will be conducted.

During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)

Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy

During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding

suturing with barbed sutures during laparoscopic ovarian cystectomy

Hyunji Lim, MD

Hee seung Kim, MD/PhD

Ga Won Yim, MD/PhD

Chae Hyeong Lee, MD/PhD

Hee Seung Kim, MD/PhD

This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis.

In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function.

Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.

Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function

A Multi-center, Randomized, Investigator-initiated Trial to Evaluate the Efficacy of PRreservation of ovArian Function, Hemostasis, and sAfety of a Hemostatic Agent Versus Suturing During Laparoscopic Ovarian Cystectomy for Endometrioma

Reduction rate of AMH level in serum 12 weeks after surgery

Reduction rate of AMH level in serum 48 weeks after surgery

Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control

Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes

The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle

whether patients are transfused during admission period

any adverse events during admission period

time from anesthesia start to delivery of patient to recovery room

Seoul National University Hospital

associate professor

Infections

Skin and Connective Tissue Diseases

Breast Neoplasms

Communicable Diseases

Surgical Wound Infection

Anti-Infective Agents

Lipid Regulating Agents

Anti-Infective Agents, Local

Triclosan

Vicryl plus and Monocryl plus is the active comparator arm. These are the "active" sutures, coated with triclosan antiseptic, being used in the closure of skin and subcutaneous tissues after breast cancer surgery.

"Plain" Vicryl or Monocryl suture currently the standard which are not coated with triclosan, serve as the control.

Vicryl plus and Monocryl plus

wound closure skin and subcutaneous tissues

wound closure with Vicryl and Monocryl

This is a randomised pilot study comparing conventional sutures (Vicryl and Monocryl) with antiseptic coated equivalents (Vicryl plus andf Monocryl plus) in elective breast surgery.

Vicryl Plus and Monocryl Plus in Breast Surgery

Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery

Cardiff and Vale University Health Board

Pathological Conditions, Anatomical

The hemostasis method of the experimental group is to use both the absorbable hemostat and suture.

the absorbable hemostat and suture

The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.

electrocoagulation and suture

The placebo comparator is to use suture alone for hemostasis.

suture

Yanru Long

The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts.

Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst

Antral follicle count (AFC) generally refers to the basic follicles in ovaries, which have not yet begun to develop. If the number of AFC is within the normal range (usually 5-10), it indicates that the ovarian reserve function is normal. If the number is low, it generally means that the ovarian reserve function is relatively low. If the number is high, it may be caused by polycystic ovary syndrome. Besides, AFC can be detected through ultrasound examination, and the number of AFC can directly reflect the ovarian reserve of each ovary.

Anti-Mullerian hormone (AMH), which can be detected through blood tests, is considered a reliable marker produced by ovarian granulosa cells. The level of AMH indirectly reflects the number of ovarian follicular pools and the joint reserve of both ovaries. In addition, the level of AMH fluctuates less throughout the menstrual cycle. Besides, AMH is almost unrelated to the menstrual cycle and is not affected by gonadotropin-releasing hormone (GnRH) agonists or oral contraceptives.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection	NCT06344962	Suture, Complic...	Absorbable Sutu... Non-absorbable ...	18 Years - 75 Years	The Affiliated Hospital of Qingdao University
A Comparative Study of Scar Quality and Safety According to Suture Materials Following Excision of Benign Tumors	NCT05240820	Scar Quality As...	multi-layer wou...	18 Years - 80 Years	Korea University Guro Hospital
Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function	NCT04643106	Benign Ovarian ...	Hemostatic agen... suturing with b...	19 Years - 45 Years	Seoul National University Hospital
Vicryl Plus and Monocryl Plus in Breast Surgery	NCT00830271	Breast Cancer S...	Vicryl plus and... wound closure w...	18 Years -	Cardiff and Vale University Health Board
Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst	NCT06350227	Ovarian Cyst Be...	the absorbable ... electrocoagulat... suture	18 Years - 40 Years	West China Second University Hospital

Spots Global Cancer Trial Database for suture

Every month we try and update this database with for suture cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for suture

Every month we try and update this database with for suture cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for suture cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.