TRAM STUDY
Initial experience with rectus sheath repair using TIGR® Matrix Surgical Mesh following pedicled TRAM flap for breast reconstruction.
Prospective Randomized Controlled Trial – SPSS software / Double blind – a Multi-Centre Study
National University Hospital & Tan Tock Seng Hospital Download the CAM presentation Download a TRAM case from this study Methodology Post operative inpatient care standardized following a breast reconstruction protocol. Clinical parameters: Pain score, patient questionaire Conclusion
All patients scheduled from pedicled TRAM flap from age 21-80.
Consent taken according to ethics protocol.
Randomized on day of operation into 2 groups.
Standardized data collection form:
Age
BMI
Medical history
Risk factors : previous surgical operations, previous gestation, smoking, occupation
Immediate inhospital post-operative complications.
Weekly follow up in 1st month. 3, 6, 12 months.
Wound infection
Haematoma
Seroma formation after removal of drains
Extrusion and fistula
Asymmetry, bulge or hernia of the abdominal wall
Early results show no increase in post-operative complications.
Mesh is easy to handle and use.
Being completely resorbable, it does not confer the usual complications associated with permanent implants.
Occurrence of complications like hernias will require long term surveillance.
Long term follow up is required.
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First in Man
TIGR® Matrix Surgical Mesh has undergone clinical trials in Sweden and has been favorably received by participating surgeons.
MATERIALS AND METHODS
This is a first-in-man, open, uncontrolled clinical study performed at two sites in Sweden. 40 patients with primary inguinal hernias were enrolled for Lichtenstein repair using TIGR® Matrix. Patients were followed up at 0.5, 1, 3, 6, 12 and 24 months. Longer-term monitoring along with ultrasound examination will be performed at 3 years. Pain assessment was performed using a visual analogue scale (VAS 0-100) and a questionnaire in order to follow up other factors affecting the patients’ quality of life.
RESULTS
- All patients followed a normal postoperative course. After 24 months, no serious adverse events were reported. 3 recurrences has been confirmed of which 2 has required reoperations. The recurrences were related to direct hernias.
- Only two patients experienced mild pain (VAS<10) after 2 years and only four patients could sometimes feel the presence of a mesh in their groin. These scores compare favorably with other published data.
Initial clinical results were presented at the American Hernia Society meeting in Orlando, Florida, March 17-20, 2010.
The two year results were presented at the International Hernia Congress in New York, March 28-31 2012
In December 2012, the complete 3 year results will be submitted for publication in a peer-reviewed journal.
“It is very desirable to avoid leaving permanent foreign materials in the body. This provides us with a new tool to repair abdominal wall defects in a very logical way” said A/Prof. Stellan Björck of Sahlgrenska University Hospital, Gothenburg, Sweden. A/Prof. Björck is the Principle Investigator for the first clinical study of the TIGR® Matrix Surgical Mesh.
Of the patients recruited for this study, one in particular stands out as an excellent case of an active patient suffering from an inguinal hernia.
Martin Lamm (now 44 years old) is a competitive speed surfer from western Sweden. His eagerness to recover in time to practice for the 2010 Swedish Championships meant that he was going to be putting TIGR® Matrix to the test as soon as weather permitted.
As the 2011 season draws to a close, Martin has improved his ranking over the previous year and is extremely grateful both that he received TIGR® Matrix and that it should shortly cease to exist inside his abdomen.