Clinical trials: Suture Materials
C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract
The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis…
- Conditions
- C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract, Gastric Anastomosis (Site), Gastrointestinal Neoplasms
- Trial name
- PROMEGAT (NCT02080702)
- Testing
- Monosyn
- Where
- 5 sites in Malaysia, Philippines and 2 more
- Volunteers
- 106 people
- Sponsor
- Aesculap AG
Gingivitis, Gingival Diseases
NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery
The aim of this study is to prove that Novosyn Quick and Monosyn Quick are equivalent in early wound healing in adult patients undergoing resective periodontal surgery.
- Conditions
- Gingivitis, Gingival Diseases, Periodontal Diseases
- Trial name
- NOQMOQS (NCT05813236)
- Testing
- Novosyn® in resective periodontal surgery, Monosyn® in resective periodontal surgery
- Where
- Spain
- Volunteers
- 84 people
- Sponsor
- Aesculap AG
Skin Closure
PMCF-study Using Novosyn® Quick Suture Material for Skin Closure
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for skin closure.
- Trial name
- SKINNOQ (NCT02680886)
- Testing
- Novosyn® Quick
- Where
- 2 sites in France, Germany
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Primary Median Laparotomy
Multi-center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax® for Abdominal Wall Closure
MonoMax will be used for a continuous all-layer (except skin) suture to close abdominal wall after midline incision. The primary objective of this trial is to demonstrate that the frequency of wound infection and the frequency of…
- Trial name
- ISSAAC (NCT00572507)
- Testing
- MonoMax®
- Where
- 4 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Contusions, Incision
Dermal Wound Closure Using Silkam®
Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
- Conditions
- Contusions, Incision, Laceration
- Trial name
- DERMASILK (NCT05225714)
- Where
- Spain
- Volunteers
- 161 people
- Sponsor
- Aesculap AG
Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery, Pediatric and Adult: Skin Closure (Dermal Sutures)
Prospective, International Monosyn® Quick - Non Interventional Study
The Monosyn® Quick non-interventional study (NIS) has been designed to implement an action within the framework of a proactive post-market surveillance system.
- Conditions
- Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery, Pediatric and Adult: Skin Closure (Dermal Sutures), Women: Episiotomy, Pediatric: Urological Interventions (Circumcision, Phimosis Etc.)
- Trial name
- PRIMOQ (NCT03355001)
- Testing
- Monosyn® Quick
- Where
- 3 sites in Germany
- Volunteers
- 153 people
- Sponsor
- Aesculap AG
Oral Surgery, Tooth Extraction
Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients
- Conditions
- Oral Surgery, Tooth Extraction, Dental Implants
- Trial name
- MUCODA (NCT04390620)
- Testing
- Mucosal Closure
- Where
- 2 sites in Germany, Spain
- Volunteers
- 105 people
- Sponsor
- Aesculap AG
Coronary Heart Disease, Multi Vessel Coronary Artery Disease
Optilene® Suture for Coronary Artery Bypass Graft Surgery
The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.
- Trial name
- OPTICABG (NCT02546557)
- Testing
- Coronary Artery Bypass Graft surgery
- Where
- 4 sites in Germany, Italy and 2 more
- Volunteers
- 245 people
- Sponsor
- Aesculap AG
Gastrointestinal Diseases, Laparotomy
Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)
The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal surgery as part of a controlled randomized single blinded parallel group trial.
- Conditions
- Gastrointestinal Diseases, Laparotomy, Anastomosis, Surgical, Absorbable, Coated Sutures
- Trial name
- NCT00645684
- Testing
- Gastrointestinal Anastomosis
- Where
- 3 sites in Hungary
- Volunteers
- 210 people
- Sponsor
- Aesculap AG
Appendicitis, Cholecystitis
NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
The aim of this study is to evaluate if the application of a Chlorhexidine coated suture (Novosyn® CHD) will reduce the colonization of bacteria in comparison to an uncoated suture (Novosyn®) used for the closure of trocar wounds…
- Trial name
- NOVOTILAC (NCT04033211)
- Testing
- Novosyn® CHD for fascia and skin closure, Novosyn® for fascia and skin closure
- Where
- 4 sites in Germany, Spain
- Volunteers
- 316 people
- Sponsor
- Aesculap AG
Episiotomy
PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy.
- Trial name
- EPINOQ (NCT02762357)
- Testing
- Novosyn® Quick
- Where
- 2 sites in Spain
- Volunteers
- 46 people
- Sponsor
- Aesculap AG
Tooth, Impacted, Teeth Impact
Performance of Safety of SILKAM® Suture Material in Oral Surgery
Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.
- Conditions
- Tooth, Impacted, Teeth Impact, Tooth Impaction, Mucosal Wound
- Trial name
- SILKOS (NCT05296902)
- Testing
- Mucosal Closure
- Where
- Spain
- Volunteers
- 105 people
- Sponsor
- Aesculap AG
Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms
Gastrointestinal Anastomosis Using MonoPlus® Suture
The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice.
- Conditions
- Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms, Digestive System Neoplasm, Stomach Tumor
- Trial name
- GASTROMO (NCT04811833)
- Where
- 2 sites in Spain
- Sponsor
- Aesculap AG
Abnormal Uterine Bleeding, Endometriosis
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic…
- Conditions
- Abnormal Uterine Bleeding, Endometriosis, Uterine Prolapse, Uterine Cancer
- Trial name
- BARHYSTER (NCT06024109)
- Testing
- Closure of the Vaginal Cuff after Total Hysterectomy
- Where
- 2 sites in Germany, Spain
- Volunteers
- 132 people
- Sponsor
- Aesculap AG
Eye Diseases
Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery
This is an observational, retrospective postmarket clinical follow-up study and includes all patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres between 2018 and 2020, therefore no sample…
- Trial name
- OPHTHADA (NCT05968443)
- Testing
- ophthalmic surgery
- Where
- Malaysia
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Laceration, Incision
Optilene® Suture Material for Dermal Sutures
In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.
- Trial name
- OPTIDERMAL (NCT05240248)
- Where
- Spain
- Volunteers
- 172 people
- Sponsor
- Aesculap AG
Laceration of Skin, Injury Skin
Assessment of DAFILON® Suture Material for Skin Closure
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon®) will be evaluated for skin closure in adult and pediatric patients.
- Trial name
- SKINDA (NCT04617041)
- Where
- 2 sites in Germany, Spain
- Volunteers
- 115 people
- Sponsor
- Aesculap AG
Anastomotic Leak, Colon Cancer
Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to…
- Conditions
- Anastomotic Leak, Colon Cancer, Right Hemicolectomy
- Trial name
- LICOSARH (NCT07132970)
- Testing
- Monoplus Suture Material
- Where
- 4 sites in Germany
- Volunteers
- 249 people
- Sponsor
- Aesculap AG
Dacryocystorhinostomy, Ectropion
PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with standard suture material used in Ophthalmic surgery.
- Conditions
- Dacryocystorhinostomy, Ectropion, Entropion, Ptosis
- Trial name
- OPHTHALNOQ (NCT02761083)
- Testing
- Novosyn® Quick, Vicryl® Rapid
- Where
- Spain
- Sponsor
- Aesculap AG