Evaluation of the usage of a human acellular dermis instead of applying the surgical standard procedure for closing an open abdomen.

Phase 1

• Conditions: 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 Classification code 10000092 Term: Abdominal scan NOS abnormal System Organ Class: 100000004848; MedDRA version: 20.0 Level: LLT Classification code 10000095 Term: Abdominal symptom NOS System Organ Class: 100000004856; MedDRA version: 20.1 Level: LLT Classification code 10000096 Term: Abdominal syndrome acute System Organ Class: 100000004856; MedDRA version: 20.0 Level: LLT Classification code 10000039 Term: Abd. pain System Organ Class: 100000004856; MedDRA version: 20.0 Level: LLT Classification code 10000040 Term: Abdo pain System Organ Class: 100000004856; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2015-001309-14-DE
• Lead Sponsor: niversity of Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified