A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group (A-PART)

Aesculap

Status and phase

Completed

Phase 2

Phase 1

Conditions

Adhesions

Abdominal Cavity

Treatments

Device: A-Part® Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00646412

AAG-G-H-0602

Details and patient eligibility

About

The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.

Full description

Primary Objective:

• first assessment of the safety of applying A-Part® Gel as adhesion prophylaxis after major abdominal surgery by specific observation of two major complications of abdominal surgery (wound healing impairment, and/or postoperative peritonitis) in comparison to a control group.

Secondary Objectives:

To further evaluate the safety of A-Part® Gel by comparing the incidences of adverse events between the treatment groups (with special attention to anastomosis leakage)
To explore the efficacy of A-Part® Gel in reducing post-surgical adhesions after median laparotomy

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of both sexes, who are candidates for a primary and elective median abdominal incision with a length of ≥ 15 cm 2.
Age ≥ 18 years
Patients who are legally capable and able to understand the nature, significance and consequences of the study and are willing and able to comply with the study protocol and the follow up
Written informed consent obtained according to international guidelines and local law. Informed consent will be documented by the volunteer's dated signature, which will be also signed and dated by the investigator
Patients with an expected survival time >12 months
For female adults of reproductive potential: Negative pregnancy test at visit 1 and sufficient contraception from time of written consent up to at least 4 months

Exclusion criteria

Patients with a previous median laparotomy and any other abdominal surgery (exceptions: previous laparoscopic appendectomy, cholecystectomy, inguinal hernia repair, gynecological tube sterilisation)
Patients with a known history of adhesions or a known history of peritonitis
Patients with a known sensitivity to polyvinylalcohol and/or carboxymethylcellulose
Simultaneous participation of the patient in another clinical trial or participation in a clinical trial within the last 30 days prior to signing the Informed consent form
Patients with ASA > 3 or emergency patients (including severe psychic diesease)
Patients with ascites > 200 ml
Patients with peritoneal carcinosis or peritoneal dialysis
Patients with a diagnosed peritonitis, intra-abdominal abscess or other intra-abdominal infection
Patient with renal impairment (Creatinine > 1.3 mg/dl)
Patients with systemic immunosuppression (e.g. hydrocortisone > 50mg daily [oral/i.v.] at any day or any equivalent dosage; other immunosuppressants like Azathioprin, Mycophenolatmofetil, Ciclosporin, Everolimus, Methotrexat, ect.), chemotherapy or radiotherapy within the last 2 weeks prior to surgery
Surgical procedures or patient characteristics which require insertion of more than 2 intra-abdominal drainages
Women within a pregnancy or breast-feeding mothers or women who wish to get pregnant within the next 4 months after surgery or women without sufficient contraceptive care