AdhesionsPhase 1/2A-PARTNCT00646412
A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group
A Phase 1/2 study testing A-Part® Gel in people with Adhesions and Abdominal Cavity, run by Aesculap AG at 1 site in Germany.
Trial summary
The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesions, Abdominal Cavity
- What is being tested?
- A-Part® Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Aug 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universitaet Muenchen
Munich, Bavaria, 81377
About this study
Official title: A Prospective, Randomised, Controlled, Single-blind Phase I-II Clinical Trial on the Safety of A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group
The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.
Read the detailed 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
- Conditions
- Adhesions, Abdominal Cavity
- Being tested
- A-Part® Gel
- Keywords
- randomized, controlled, single-blind study, Adhesion Prophylaxis, Abdominal Surgery, Laparotomy, median
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-Part® GelDevice
10 - 20 ml of A-Part® Gel will be administered before abdominal wall closure in a standardised fashion
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | A-Part® Gel Receives: Device: A-Part® Gel |
| B | No intervention | untreated control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of wound healing impairment and/or postoperative peritonitis after surgery
Measured: 28 (+10) days
Secondary outcomes (3)
Occurrence of anastomosis leakage after surgery
Measured: within 28 (+10) days
Occurrence of adverse events (AEs) and serious adverse events (SAEs) after surgery
Measured: postoperative hospital stay and up to 3 months
Adhesion rates along the scar examined by ultrasound-assessment
Measured: 14 days (range: day 7-14), 28 days (+10 days), 3 months (± 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for AdhesionsStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl-Walter Jauch, Prof.Dr., Principal investigator, Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646412
- Sponsor's protocol ID
- AAG-G-H-0602
- Acronym
- A-PART
- Status last verified
- Sep 2015
- First submitted
- 25 Mar 2008
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ellis H. Wound repair. Reaction of the peritoneum to injury. Ann R Coll Surg Engl. 1978 May;60(3):219-21. No abstract available.
PubMed 646316Parker MC, Ellis H, Moran BJ, Thompson JN, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Briena F, Buchan S, Crowe AM. Postoperative adhesions: ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum. 2001 Jun;44(6):822-29; discussion 829-30. doi: 10.1007/BF02234701.
PubMed 11391142Ellis H. Intraabdominal and postoperative peritoneal adhesions. J Am Coll Surg. 2005 May;200(5):641-4. doi: 10.1016/j.jamcollsurg.2004.10.023. No abstract available.
PubMed 15848353Parker MC, Wilson MS, Menzies D, Sunderland G, Clark DN, Knight AD, Crowe AM; Surgical and Clinical Adhesions Research (SCAR) Group. The SCAR-3 study: 5-year adhesion-related readmission risk following lower abdominal surgical procedures. Colorectal Dis. 2005 Nov;7(6):551-8. doi: 10.1111/j.1463-1318.2005.00857.x.
PubMed 16232234Gomel V. Reproductive surgery. Minerva Ginecol. 2005 Feb;57(1):21-8.
PubMed 15758863Fazio VW, Cohen Z, Fleshman JW, van Goor H, Bauer JJ, Wolff BG, Corman M, Beart RW Jr, Wexner SD, Becker JM, Monson JR, Kaufman HS, Beck DE, Bailey HR, Ludwig KA, Stamos MJ, Darzi A, Bleday R, Dorazio R, Madoff RD, Smith LE, Gearhart S, Lillemoe K, Gohl J. Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection. Dis Colon Rectum. 2006 Jan;49(1):1-11. doi: 10.1007/s10350-005-0268-5.
PubMed 16320005Yamaoka T, Takahashi Y, Fujisato T, Lee CW, Tsuji T, Ohta T, Murakami A, Kimura Y. Novel adhesion prevention membrane based on a bioresorbable copoly(ester-ether) comprised of poly-L-lactide and Pluronic: in vitro and in vivo evaluations. J Biomed Mater Res. 2001 Mar 15;54(4):470-9. doi: 10.1002/1097-4636(20010315)54:43.0.co;2-x.
PubMed 11426591Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update. 2001 Nov-Dec;7(6):567-76. doi: 10.1093/humupd/7.6.567.
PubMed 11727865Becker JM, Stucchi AF. Intra-abdominal adhesion prevention: are we getting any closer? Ann Surg. 2004 Aug;240(2):202-4. doi: 10.1097/01.sla.0000133118.38686.d0. No abstract available.
PubMed 15273541Treutner KH, Bertram P, Loser S, Winkeltau G, Schumpelick V. [Prevention and therapy of intra-abdominal adhesions. A survey of 1,200 clinics in Germany]. Chirurg. 1995 Apr;66(4):398-403. German.
PubMed 7634953Holmdahl L, Risberg B, Beck DE, Burns JW, Chegini N, diZerega GS, Ellis H. Adhesions: pathogenesis and prevention-panel discussion and summary. Eur J Surg Suppl. 1997;(577):56-62.
PubMed 9076453Sjosten AC, Blomgren H, Larsson B, Edelstam GA. Precautions taken to prevent adhesions--a questionnaire study among Swedish obstetricians and gynaecologists. Eur J Surg. 1999 Aug;165(8):736-41. doi: 10.1080/11024159950189492.
PubMed 10494637Trickett JP, Rainsbury RM, Green R. Paradoxical outcome after use of hyaluronate barrier to prevent intra-abdominal adhesions. J R Soc Med. 2001 Apr;94(4):183-4. doi: 10.1177/014107680109400408. No abstract available.
PubMed 11317621Besheer A, Mader K, Kaiser S, Kressler J, Weis C, Odermatt EK. Tracking the urinary excretion of high molar mass poly(vinyl alcohol). J Biomed Mater Res B Appl Biomater. 2007 Aug;82(2):383-9. doi: 10.1002/jbm.b.30743.
PubMed 17238166Kaneo Y, Hashihama S, Kakinoki A, Tanaka T, Nakano T, Ikeda Y. Pharmacokinetics and biodisposition of poly(vinyl alcohol) in rats and mice. Drug Metab Pharmacokinet. 2005 Dec;20(6):435-42. doi: 10.2133/dmpk.20.435.
PubMed 16415529
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Controlled, Single-blind Phase I-II Clinical Trial on the Safety of A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group
- ClinicalTrials.gov ID
- NCT00646412
- Acronym / sponsor ID
- A-PART / AAG-G-H-0602
- Conditions
- Adhesions, Abdominal Cavity
- Keywords
- randomized, controlled, single-blind study, Adhesion Prophylaxis, Abdominal Surgery, Laparotomy, median
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: A-Part® GelA-Part® Gel |
| B | No intervention | –untreated control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-Part® Gel10 - 20 ml of A-Part® Gel will be administered before abdominal wall closure in a standardised fashion | Device | A |
Primary outcome
Occurrence of wound healing impairment and/or postoperative peritonitis after surgery
Time frame: 28 (+10) days
3 secondary outcomes
Occurrence of anastomosis leakage after surgery
Time frame: within 28 (+10) days
Occurrence of adverse events (AEs) and serious adverse events (SAEs) after surgery
Time frame: postoperative hospital stay and up to 3 months
Adhesion rates along the scar examined by ultrasound-assessment
Time frame: 14 days (range: day 7-14), 28 days (+10 days), 3 months (± 14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Background: PubMed 646316Ellis H. Wound repair. Reaction of the peritoneum to injury. Ann R Coll Surg Engl. 1978 May;60(3):219-21. No abstract available.
- Background: PubMed 11391142Parker MC, Ellis H, Moran BJ, Thompson JN, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Briena F, Buchan S, Crowe AM. Postoperative adhesions: ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum. 2001 Jun;44(6):822-29; discussion 829-30. doi: 10.1007/BF02234701.
- Background: PubMed 15848353Ellis H. Intraabdominal and postoperative peritoneal adhesions. J Am Coll Surg. 2005 May;200(5):641-4. doi: 10.1016/j.jamcollsurg.2004.10.023. No abstract available.
- Background: PubMed 16232234Parker MC, Wilson MS, Menzies D, Sunderland G, Clark DN, Knight AD, Crowe AM; Surgical and Clinical Adhesions Research (SCAR) Group. The SCAR-3 study: 5-year adhesion-related readmission risk following lower abdominal surgical procedures. Colorectal Dis. 2005 Nov;7(6):551-8. doi: 10.1111/j.1463-1318.2005.00857.x.
- Background: PubMed 15758863Gomel V. Reproductive surgery. Minerva Ginecol. 2005 Feb;57(1):21-8.
- Background: PubMed 16320005Fazio VW, Cohen Z, Fleshman JW, van Goor H, Bauer JJ, Wolff BG, Corman M, Beart RW Jr, Wexner SD, Becker JM, Monson JR, Kaufman HS, Beck DE, Bailey HR, Ludwig KA, Stamos MJ, Darzi A, Bleday R, Dorazio R, Madoff RD, Smith LE, Gearhart S, Lillemoe K, Gohl J. Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection. Dis Colon Rectum. 2006 Jan;49(1):1-11. doi: 10.1007/s10350-005-0268-5.
- Background: PubMed 11426591Yamaoka T, Takahashi Y, Fujisato T, Lee CW, Tsuji T, Ohta T, Murakami A, Kimura Y. Novel adhesion prevention membrane based on a bioresorbable copoly(ester-ether) comprised of poly-L-lactide and Pluronic: in vitro and in vivo evaluations. J Biomed Mater Res. 2001 Mar 15;54(4):470-9. doi: 10.1002/1097-4636(20010315)54:43.0.co;2-x.
- Background: PubMed 11727865Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update. 2001 Nov-Dec;7(6):567-76. doi: 10.1093/humupd/7.6.567.
- Background: PubMed 15273541Becker JM, Stucchi AF. Intra-abdominal adhesion prevention: are we getting any closer? Ann Surg. 2004 Aug;240(2):202-4. doi: 10.1097/01.sla.0000133118.38686.d0. No abstract available.
- Background: PubMed 7634953Treutner KH, Bertram P, Loser S, Winkeltau G, Schumpelick V. [Prevention and therapy of intra-abdominal adhesions. A survey of 1,200 clinics in Germany]. Chirurg. 1995 Apr;66(4):398-403. German.
- Background: PubMed 9076453Holmdahl L, Risberg B, Beck DE, Burns JW, Chegini N, diZerega GS, Ellis H. Adhesions: pathogenesis and prevention-panel discussion and summary. Eur J Surg Suppl. 1997;(577):56-62.
- Background: PubMed 10494637Sjosten AC, Blomgren H, Larsson B, Edelstam GA. Precautions taken to prevent adhesions--a questionnaire study among Swedish obstetricians and gynaecologists. Eur J Surg. 1999 Aug;165(8):736-41. doi: 10.1080/11024159950189492.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Walter Jauch, Prof.Dr. principal investigator
Chirurgische Klinik und Poliklinik - Großhadern, Klinikum der Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A-Part® Gel in people with Adhesions and Abdominal Cavity, run by Aesculap AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of wound healing impairment and/or postoperative peritonitis after surgery (time frame: 28 (+10) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00646412, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.