NCT01901068

Brief Summary

A great number of different suture techniques and suture materials are in use in order to reconstitute the abdominal wall integrity, but there is no surgical gold standard for abdominal wall closure until today. Various Meta-Analyses and randomized controlled trials have been performed, which compared non-absorbable or long-term absorbable versus rapid absorbable suture materials or monofilament versus multifilament suture materials, or continuous versus interrupted suture techniques respectively. This lack of evidence has the following outcome: burst abdomen is observed in 1-3% of patients within the first days after a laparotomy. The incidence of abdominal wall hernias 12 months postoperatively is estimated to be up to 20% (range 9 to 20%) . Wound infections develop in 3 to 21% of patients undergoing a median laparotomy within the first 30 days. At present most surgeons favour monofilament long-absorbable continuous sutures as the most suitable material for closing abdominal wounds after midline laparotomy.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

2.6 years

First QC Date

July 5, 2013

Last Update Submit

December 12, 2024

Conditions

Abdominal Wall Wound

Keywords

LaparotomySurgical Procedures, ElectiveSuturesAbdominal Wound Closure Techniques

Outcome Measures

Primary Outcomes (2)

  • Frequency of reoperation due to burst abdomen

    participants will be followed for the duration of hospital stay, an expected average of 10 days

  • Frequency of wound infections

    participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcomes (2)

  • Incidence of wound healing until day of discharge

    participants will be followed for the duration of hospital stay, an expected average of 10 days

  • Length of hospital stay

    participants will be followed for the duration of hospital stay, an expected average of 10 days

Study Arms (1)

MonoMax

Elective primary laparotomy

Device: MonoMax

Interventions

MonoMaxDEVICE

Abdominal wall will be closed with MonoMax after an elective primary laparotomy.

MonoMax

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

  • Age 18 years and older
  • Elective primary laparotomy
  • Written informed consent

You may not qualify if:

  • Peritonitis
  • Emergency surgery
  • Severe psychiatric and neurologic disease
  • Drug- and / or alcohol abuse according to local standard
  • Lack of informed consent
  • Current immunosuppressive therapy
  • Chemotherapy within the 2 weeks before operation
  • Radiotherapy of the abdomen completed less than 8 before surgery
  • Pregnant or breast-feeding women
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chirurgicka klinika, Fakultni nemocnine

Hradec Králové, 500 05, Czechia

Location

Chirurgicka klinika, Fakultni nemocnine

Olomouc, 77520, Czechia

Location

Central Emergency Military Hospital

Bucharest, Romania

Location

Related Publications (3)

  • Fink C, Baumann P, Wente MN, Knebel P, Bruckner T, Ulrich A, Werner J, Buchler MW, Diener MK. Incisional hernia rate 3 years after midline laparotomy. Br J Surg. 2014 Jan;101(2):51-4. doi: 10.1002/bjs.9364. Epub 2013 Nov 26.

    PMID: 24281948BACKGROUND

  • Fischer L, Baumann P, Husing J, Seidlmayer C, Albertsmeier M, Franck A, Luntz S, Seiler CM, Knaebel HP. A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]. BMC Surg. 2008 Jul 21;8:12. doi: 10.1186/1471-2482-8-12.

    PMID: 18644124BACKGROUND

  • Albertsmeier M, Seiler CM, Fischer L, Baumann P, Husing J, Seidlmayer C, Franck A, Jauch KW, Knaebel HP, Buchler MW. Evaluation of the safety and efficacy of MonoMax(R) suture material for abdominal wall closure after primary midline laparotomy-a controlled prospective multicentre trial: ISSAAC [NCT005725079]. Langenbecks Arch Surg. 2012 Mar;397(3):363-71. doi: 10.1007/s00423-011-0884-6. Epub 2011 Dec 20.

    PMID: 22183105BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2013

First Posted

July 17, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CZ(2)RO(1)