Short Stitch Monomax®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-12-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A number of studies identifies abdominal hernia as the most frequent postoperative complication following laparotomy with percentages of 9-20% - depending on duration of follow-up. It is based on a multifactorial basis, including factors concerning individual, patient-specific factors, factors related to the operational technique as well as particular surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate (dehiscence) \< 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being 6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication rate of up to 50 % has to be expected. According to new, first findings from recent studies the rates of wound healing complication and burst abdomen can be reduced significantly. Depending on the study, to almost 50%. The principle is based on the reduction of the stitch length and type of the inserted suture. The stitches are closer and with less distance to the edge of fascia. Due to the much thinner suture it still comes here to a quantitative reduction of the inserted suture. The data collected using the MonoMax® suture in the short stitch technique will be compared to the results of the ISSAAC trial, in which the MonoMax® suture was used in the long stitch suture technique. The generated data are thus subject of retrospective comparison with a historical control group (ISSAAC study).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00572507

Primary Median Laparotomy

COMPLETED NA

Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy

NCT04982653

Liver and Intrahepatic Bile Duct Neoplasm Metastatic Malignant Neoplasm in the Liver Primary Malignant Liver Neoplasm

RECRUITING PHASE2

When Closing Midline Incisions, do Small Stitches Reduce the Risk for Incisional Hernia, Wound Infection or Dehiscence?

NCT00508053

Wound Infection Incisional Hernia Wound Dehiscence

COMPLETED NA

MonoMax for Abdominal Wall Closure

NCT01901068

Abdominal Wall Wound

COMPLETED

PDS*Plus and Wound Infections After Laparotomy

NCT00998907

Wound Infection Incisional Hernia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dehiscence of Laparotomy Wound Surgical Wound Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Short Stitch

Short stitch suture technique (6:1) for abdominal all closure stitch interval \< 0,5 cm and lateral 0,5-0,8 cm

Short Stitch

Intervention Type PROCEDURE

MonoMax® suture material USP (United States Pharmacopeia) 2/0, 150 cm, HR (half-round) 26 mm needle, will be applied in the short stitch technique (6:1) for abdominal wall closure.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Short Stitch

MonoMax® suture material USP (United States Pharmacopeia) 2/0, 150 cm, HR (half-round) 26 mm needle, will be applied in the short stitch technique (6:1) for abdominal wall closure.

Intervention Type PROCEDURE