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Primary Median LaparotomyISSAACNCT00572507

Multi-center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax® for Abdominal Wall Closure

A study testing MonoMax® in people with Primary Median Laparotomy, run by Aesculap AG at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

MonoMax will be used for a continuous all-layer (except skin) suture to close abdominal wall after midline incision. The primary objective of this trial is to demonstrate that the frequency of wound infection and the frequency of reoperation due to burst-abdomen after primary median laparotomy for elective surgical… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Median Laparotomy
What is being tested?
MonoMax®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
4 sitesGermany
Study dates
Dec 2007to Jul 2009
Phase
Interventional
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

  • Age equal or greater than 18 years
  • Expected survival time > 12 months
  • Patient undergoing elective and primary median laparotomy
  • BMI < 35
  • Expected length of skin incision > 15 cm

Who cannot join

  • Peritonitis
  • Emergency surgery
  • Coagulopathy
  • Current immunosuppressive therapy (> 40 mg of a Corticoid per day or Azathioprin)
  • Chemotherapy within 2 weeks before operation
  • Radiotherapy of the abdomen completed less than 8 weeks before operation

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • St. Bonifatius-Hospital; Chirurgische Klinik

    Lingen, 49808

  • Universitaetsklinikum Giessen-Marburg, Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie

    Marburg, 35043

  • Universitaetsklinikum Muenchen Grosshadern

    München, 81377

Other trials in Germany

About this study

Official title: A Historically-controlled Single-arm Multi-center Prospective Trial to Evaluate the Safety and Efficacy of Aesculap MonoMax® Suture Material for Abdominal Wall Closure After Primary Median Laparotomy

MonoMax will be used for a continuous all-layer (except skin) suture to close abdominal wall after midline incision. The primary objective of this trial is to demonstrate that the frequency of wound infection and the frequency of reoperation due to burst-abdomen after primary median laparotomy for elective surgical intervention are equal or lower than in the INSECT trial. The secondary objectives are to demonstrate that the length of postoperative hospital stay and the frequency of abdominal hernias 12 months after the surgery are equal or lower than in the INSECT trial. [Knaebel HP et al., 2005]

Being tested
MonoMax®
Keywords
Absorbable Monofilament Suture Material, Safety and Efficacy, Abdominal Wall/ Fascia, Laparotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MonoMax®Device

    Also called ultra-longterm-absorbable monofilament suture Aesculap MonoMax®

    Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy

Study groups in NCT00572507
Study groupRoleWhat they receive
MonoMaxExperimentalMonoMax is used for abdominal wall closure
Receives: Device: MonoMax®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy

    Measured: till day of discharge

Secondary outcomes (1)

  1. length of postoperative hospital stay after surgery and frequency of incisional hernias 12 months after the surgery and frequency of wound infections 30 days postoperative

    Measured: different

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionAug 2008
  4. Study completionJul 2009

Resources

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00572507
Sponsor's protocol ID
AAG-G-H-0701
Acronym
ISSAAC
Status last verified
May 2015
First submitted
11 Dec 2007
Last updated
28 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Amgwerd M, Decurtins M, Largiader F. [Hernia of the surgical scar--predisposition or inadequate suture technique?]. Helv Chir Acta. 1992 Aug;59(2):345-8. No abstract available. German.

    PubMed 1428925

  • Eisner L, Harder F. [Incisional hernias]. Chirurg. 1997 Apr;68(4):304-9. doi: 10.1007/s001040050193. German.

    PubMed 9206624

  • Zimmermann G, Muller G, Haid A. [Surgical therapy of incisional hernias]. Chirurg. 1991 Sep;62(9):656-62. No abstract available. German.

    PubMed 1748022

  • Luijendijk RW, Lemmen MH, Hop WC, Wereldsma JC. Incisional hernia recurrence following "vest-over-pants" or vertical Mayo repair of primary hernias of the midline. World J Surg. 1997 Jan;21(1):62-5; discussion 66. doi: 10.1007/s002689900194.

    PubMed 8943179

  • Manninen MJ, Lavonius M, Perhoniemi VJ. Results of incisional hernia repair. A retrospective study of 172 unselected hernioplasties. Eur J Surg. 1991 Jan;157(1):29-31.

    PubMed 1675878

  • Paul A, Lefering R, Kohler L, Eypasch E. [Current practice of incisional hernia reconstruction in Germany]. Zentralbl Chir. 1997;122(10):859-61. German.

    PubMed 9446447

  • Paul A, Korenkov M, Peters S, Fischer S, Holthausen U, Kohler L, Eypasch E. [Mayo duplication in treatment of incisional hernia of the abdominal wall after conventional laparotomy. Results of a retrospective analysis and comparison with the literature]. Zentralbl Chir. 1997;122(10):862-70. German.

    PubMed 9446448

  • Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg. 2002 May;89(5):534-45. doi: 10.1046/j.1365-2168.2002.02083.x.

    PubMed 11972542

  • Klinge U, Conze J, Limberg W, Brucker C, Ottinger AP, Schumpelick V. [Pathophysiology of the abdominal wall]. Chirurg. 1996 Mar;67(3):229-33. German.

    PubMed 8681695

  • Irvin TT, Stoddard CJ, Greaney MG, Duthie HL. Abdominal wound healing: a prospective clinical study. Br Med J. 1977 Aug 6;2(6083):351-2. doi: 10.1136/bmj.2.6083.351.

    PubMed 329940

  • Osther PJ, Gjode P, Mortensen BB, Mortensen PB, Bartholin J, Gottrup F. Randomized comparison of polyglycolic acid and polyglyconate sutures for abdominal fascial closure after laparotomy in patients with suspected impaired wound healing. Br J Surg. 1995 Aug;82(8):1080-2. doi: 10.1002/bjs.1800820824.

    PubMed 7648158

  • Gys T, Hubens A. A prospective comparative clinical study between monofilament absorbable and non-absorbable sutures for abdominal wall closure. Acta Chir Belg. 1989 Sep-Oct;89(5):265-70.

    PubMed 2530745

  • Bucknall TE, Ellis H. Abdominal wound closure--a comparison of monofilament nylon and polyglycolic acid. Surgery. 1981 Jun;89(6):672-7.

    PubMed 6264641

  • Israelsson LA, Jonsson T, Knutsson A. Suture technique and wound healing in midline laparotomy incisions. Eur J Surg. 1996 Aug;162(8):605-9.

    PubMed 8891617

  • Leaper DJ, Allan A, May RE, Corfield AP, Kennedy RH. Abdominal wound closure: a controlled trial of polyamide (nylon) and polydioxanone suture (PDS). Ann R Coll Surg Engl. 1985 Sep;67(5):273-5.

    PubMed 3931536

Questions about this trial

What is this clinical trial studying?

A study testing MonoMax® in people with Primary Median Laparotomy, run by Aesculap AG at 4 sites 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 5 inclusion and 6 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

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?

frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy (time frame: till day of discharge). 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 NCT00572507, which also lists 28 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 28 May 2015.

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