open abdomen MedDRA version: 20.0 Level: LLT Classification code 10000082 Term: Abdominal pain generalised System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10000085 Term: Abdominal pain NOS System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT
Conditions
Interventions
Trade Name: Epiflex®
Product Name: Epiflex®
Pharmaceutical Form: Implant
Trade Name: Ethicon Vicryl™
Product Name: Ethicon Vicryl™
Sponsors
University of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. open abdomen patients in the context of a severe peritonitis with the underlying focus being cured 2. it should anatomically and from the surgical point of view be possible toprovid a cutaneous cover of the Epiflex®, minor rests could be treated by NPW therapy (VAC therapy) 3. patients themselves of in the case of a patient not capable of giving consent his/her legal representative must provide written informed consent prior the performance of study-specific procedures and must be willing to comply with the intervention and follow-up examinations of the study 4. patients aged = 18 years 5. treatment of peritonitis must be completed (necessity for re-laparotomy caused by the Epiflex®/Lavage should be very unlikely) 6. patients must comply to not become pregnant within the time span of 24 weeks after Implantation of the Epiflex®/Ethicon Vicryl™ 7. adequate knowledge of the german language to understand the patient Information and implement the planned study procedures according to the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. patients with gastrointestinal leakage in upper GI tract or proximal jejunum 2. patients with leakage or fistula within hepatobiliar or pancreatic system 3. patients with fluoring pancreatitis 4. patients with uncontrolled intraabdominal malignant disease 5. patients with open abdomen that have not been able to get mobilized (ECOG 4) or are expected not be able to be mobilized until 12 weeks after surgical study invention (ECOG 4) 6. patients bearing a pace maker 7. patients under dialysis treatment 8. patients whose abdominal walls hiscerence extends the largest available piece of (Epiflex®/Ethicon Vicryl™) 9. patients with a life expectancy under 12 months 10. patients under immunosuppression (for example those having underwent organ transplantation) 11. patients under treatment of angiogenic inhibitors 12. patients with existing diseases of the hematopoietic system 13. patients being pregnant and planning pregnancy within 24 weeks +/- 14 days after surgical implantation of the Epiflex®/ Ethicon Vicryl™ 14. patients not capable of giving consent and with no legal representative at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to avoid ventral hernie building by applying Epiflex® for closure of the open abdomen instead of the standard technique (Ethicon Vicryl™);Secondary Objective: to improve the patient's quality of life due to the avoidance of ventral hernia building in patients having been subjected to implantation of the Epiflex® instead of the standard technique (Ethicon Vicryl™);Primary end point(s): to avoid ventral hernie building by applying Epiflex® for the closure of an open abdomen instead of the standard technique (Ethicon Vicryl™);Timepoint(s) of evaluation of this end point: 6 months after surgical implantation of Epiflex®/Ethicon Vicryl™ | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: life quality questionaires (EuraHS- QoL und SF-36) to determine the patient's quality of life will be filled in by each patient 1-2 days prior to release fom hospital, 12 weeks +/- 7 days, 24 weeks +/- 14 days and 12 months +/- 14 days after surgical Implantation of the Epiflex®/Ethicon Vicryl™, respectively.;Secondary end point(s): to improve the patient's quality of life due to the avoidance of ventral hernia building in patients having been subjected to implantation of the Epiflex® instead of the standard technique (Ethicon Vicryl™) | — |
Countries
Germany
Contacts
Public ContactMINDED Project Management Office
University Medical Centre Mannheim
Outcome results
None listed