ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-11-30

Brief Summary

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

The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects

Related Clinical Trials

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

A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects

NCT01214252

Abdominal Wall Defects

COMPLETED

Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

NCT00713427

Biliary Strictures Caused by Malignant Neoplasms

COMPLETED NA

Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

NCT01774019

Pancreatic Carcinoma

COMPLETED NA

Metal or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.

NCT02166840

Obstructive Jaundice Periampullary Tumour

COMPLETED PHASE2

Winged Perimeter Versus Traditional Plastic Biliary Stent for Malignant Bile Duct Obstruction

NCT01514214

Malignant Tumor of Extrahepatic Bile Duct

COMPLETED NA

Detailed Description

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

This will be a prospective, multi-centre, non-randomized study to collect post-market clinical data on Permacol™ Biological Implant following complex abdominal wall repair (including abdominal wall defects and fascial dehiscence). The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 6 months, 12 months, 24 months, and 36 months post-surgery.

The study will enroll up to 200 subjects at up to 20 sites. Enrollment is anticipated to take between 18 and 24 months.

Conditions

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

Hernia, Abdominal Abdominal Injuries

Study Design

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

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Subjects who meet all of the following criteria will be eligible for study enrollment:

1. Subjects who are 18 years of age and older
2. Subjects of either sex
3. Subjects who require complex abdominal repair using Permacol™ Biological Implant.
4. Subjects who are willing and able to adhere to protocol requirements and provide written informed consent

Exclusion Criteria

All subjects who meet any of the following criteria should not be enrolled into the study:

1. Subjects who are pregnant
2. Subjects with a medical condition that in the opinion of the investigator may preclude participation (e.g. Ehlers Danlos Syndrome) or interfere with completion of study follow-up
3. Subjects may not participate in any other clinical study that clinically interferes with this study while enrolled
4. Concomitant use of a synthetic or another biologic mesh
5. Subjects who require use of Permacol™ as only temporary closure with planned reoperation, or Permacol™ used as a temporary dressing in an open abdomen
6. Subject who has systemic sepsis at the time of Permacol™ implantation
7. Subject with ongoing necrotizing pancreatitis
8. Subject who requires use of Permacol™ in parastomal hernia repair alone, where there is no other anterior wall repair
9. Subject who requires prophylactic use of Permacol™ in the formation of stoma with anterior wall repair
10. Permacol™ used in pelvic floor reconstruction

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No