Completed

NCT Number: NCT00572507

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

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]

Completed

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Key information

Conditions

Primary Median Laparotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitaetsklinikum Heidelberg, Heidelberg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MonoMax®

Device

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

Other names: ultra-longterm-absorbable monofilament suture Aesculap MonoMax®

Primary outcomes

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

Time frame: till day of discharge

Secondary outcomes

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

Time frame: different

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study 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

Acronym: ISSAAC

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Dec 13, 2007
Registry last updated: May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.