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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will generate further clinical evidence for the use and the benefit of a Chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. The benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novosyn® | Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine |
| |
| Polyglactin 910 | Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novosyn® in emergency or elective laparotomy or laparoscopic surgery | Device | Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of surgical site infection (superficial (A1) and deep (A2) | The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). | until 30 days + 5 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Handling of the suture material | Assessment of the handling of the suture material intraoperatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor). | intraoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing wound closure after emergency or elective laparoscopic or laparotomy surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaume Garcia Lopez | Contact | +34935866200 | info@bbraun.com | |
| Ricard Rosique | Contact | info@bbraun.com |
| Name | Affiliation | Role |
|---|---|---|
| Antonio José Torres Garcia, Prof. Dr. | Hospital San Carlos, Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pineta Grande Hospital | Recruiting | Naples | Italy |
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| Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery | Device | Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery. |
|
| Length of hospital stay |
Number of days the patient has to stay in hospital after emergency or elective laparotomy or laparoscopic surgery |
| until discharge (approximately 10 days after surgery) |
| Time to return to work | Number of days the patient needed to return to work after emergency or elective laparotomy or laparoscopic surgery | until 30 days + 5 days after surgery. |
| Incidence of Surgical Site Infection (SSI) | Incidence of Surgical Site Infection (SSI) (superficial (A1), deep (A2) and organ space (A3)) at the time of discharge | at discharge (approximately 10 days after surgery) |
| Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class | Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class (Class I clean, Class II clean/contaminated, Class III contaminated, Class IV dirty/infected) | until 30 days + 5 days after surgery |
| Cumulative Rate of postoperative complications | Number of postoperative complications of any kind for descriptive analysis | discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery. |
| Cumulative Rate of reoperation | Number of reoperation of any kind for descriptive analysis | at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery. |
| Cumulative Rate of suture removal due to wound problems | Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) for descriptive analysis | at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery. |
| Cumulative Rate of Re-suturing | Rate of Re-suturing of any kind for descriptive analysis | at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery. |
| Hernia rate | Number of Wound Hernia including umbilical hernia verified by ultra-sound examination | 30 days + 5 days postoperatively |
| Hospital Clínico San Carlos | Recruiting | Madrid | Spain |
|
| Hospital Universitario de Canarias | Recruiting | Santa Cruz de Tenerife | Spain |
|
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | Spain |
|
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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