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

NCT00646412 | Completed Phase 1

• 1 other identifier: AAG-G-H-0602
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adhesions; Abdominal Cavity

Keywords

randomized, controlled, single-blind study; Adhesion Prophylaxis; Abdominal Surgery; Laparotomy, median

Outcome Measures

Primary Outcomes (1)

• Occurrence of wound healing impairment and/or postoperative peritonitis after surgery

  28 (+10) days

Secondary Outcomes (3)

• Occurrence of anastomosis leakage after surgery

  within 28 (+10) days

• Occurrence of adverse events (AEs) and serious adverse events (SAEs) after surgery

  postoperative hospital stay and up to 3 months

• Adhesion rates along the scar examined by ultrasound-assessment

  14 days (range: day 7-14), 28 days (+10 days), 3 months (± 14 days)

Study Arms (2)

A

EXPERIMENTAL

A-Part® Gel

Device: A-Part® Gel

B

NO INTERVENTION

untreated control group

Interventions

A-Part® Gel DEVICE

10 - 20 ml of A-Part® Gel will be administered before abdominal wall closure in a standardised fashion

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universitaet Muenchen

Munich, Bavaria, 81377, Germany

Location

Related Publications (36)

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• Lang R, Baumann P, Jauch KW, Schmoor C, Weis C, Odermatt E, Knaebel HP. A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part Gel as adhesion prophylaxis after major abdominal surgery versus non-treated group. BMC Surg. 2010 Jul 6;10:20. doi: 10.1186/1471-2482-10-20.

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• Lang R, Baumann P, Schmoor C, Odermatt EK, Wente MN, Jauch KW. A-Part Gel, an adhesion prophylaxis for abdominal surgery: a randomized controlled phase I-II safety study [NCT00646412]. Ann Surg Innov Res. 2015 Sep 2;9:5. doi: 10.1186/s13022-015-0014-1. eCollection 2015.

  PMID: 26336510 RESULT

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl-Walter Jauch, Prof.Dr.

  Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universität München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 28, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

DE (1)