scholarly journals Performance of biological mesh materials in abdominal wall reconstruction: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024091 ◽  
Author(s):  
David A Carver ◽  
Andrew W Kirkpatrick ◽  
Tammy L Eberle ◽  
Chad G Ball
Keyword(s):  
Informed Consent ◽  
Randomised Controlled Trial ◽  
Abdominal Wall ◽  
Controlled Trial ◽  
Abdominal Wall Reconstruction ◽  
Hernia Recurrence ◽  
Biological Mesh ◽  
Common Source ◽  
Porcine Dermis ◽  
Randomised Controlled

IntroductionAbdominal wall hernias are a common source of morbidity and mortality. The use of biological mesh has become an important adjunct in successful abdominal wall reconstruction. There are a variety of biological mesh products available; however, there is limited evidence supporting the use of one type over another. This study aims to compare the performance (eg, the rate of hernia recurrence) of either a crosslinked biological mesh product or a non-crosslinked product in patients undergoing abdominal wall reconstruction.Methods and analysisThis is a single-centre, dual arm randomised controlled trial. Patients requiring abdominal wall reconstruction will be assessed for eligibility. Eligible patients will then undergo an informed consent process following by randomisation to either (1) crosslinked porcine dermis mesh (Permacol); or (2) non-crosslinked porcine dermis mesh (Strattice). These groups will be compared for the rate of hernia recurrence at 1 and 2 years as well as the rate of postoperative complications (eg, surgical site infections).Ethics and disseminationThis study has been approved by the institution’s research ethics board and registered with clinicaltrials.gov. All eligible participants will provide informed consent prior to randomization. The results of this study may help guide the choice of biologic mesh for this population. The results of this study will be published in peer-reviewed journals as well as national and international conferences.Trial registration numberNCT02703662.

scholarly journals Management of haemothoraces in blunt thoracic trauma: study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020378 ◽  
Author(s):  
David A Carver ◽  
Alexsander K Bressan ◽  
Colin Schieman ◽  
Sean C Grondin ◽  
Andrew W Kirkpatrick ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomised Controlled Trial ◽  
Thoracic Trauma ◽  
Controlled Trial ◽  
Expectant Management ◽  
Common Source ◽  
Blunt Thoracic Trauma ◽  
Chest Drainage ◽  
Link Type ◽  
Randomised Controlled

IntroductionHaemothorax following blunt thoracic trauma is a common source of morbidity and mortality. The optimal management of moderate to large haemothoraces has yet to be defined. Observational data have suggested that expectant management may be an appropriate strategy in stable patients. This study aims to compare the outcomes of patients with haemothoraces following blunt thoracic trauma treated with either chest drainage or expectant management.Methods and analysisThis is a single-centre, dual-arm randomised controlled trial. Patients presenting with a moderate to large sized haemothorax following blunt thoracic trauma will be assessed for eligibility. Eligible patients will then undergo an informed consent process followed by randomisation to either (1) chest drainage (tube thoracostomy) or (2) expectant management. These groups will be compared for the rate of additional thoracic interventions, major thoracic complications, length of stay and mortality.Ethics and disseminationThis study has been approved by the institution’s research ethics board and registered withClinicalTrials.gov.All eligible participants will provide informed consent prior to randomisation. The results of this study may provide guidance in an area where there remains significant variation between clinicians. The results of this study will be published in peer-reviewed journals and presented at national and international conferences.Trial registration numberNCT03050502.

scholarly journals Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial

The Lancet ◽  
2020 ◽  
Vol 395 (10222) ◽  
pp. 417-426 ◽  
Author(s):  
Aneel Bhangu ◽  
Dmitri Nepogodiev ◽  
Natalie Ives ◽  
Laura Magill ◽  
James Glasbey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Biological Mesh ◽  
Stoma Site ◽  
Mesh Reinforcement ◽  
Randomised Controlled

scholarly journals Multimedia in improving informed consent for caesarean section: A randomised controlled trial

2020 ◽  
Vol 60 (5) ◽  
pp. 683-689
Author(s):  
Alice Truong ◽  
Lenore Ellett ◽  
Lauren Hicks ◽  
Gabrielle Pell ◽  
Susan P. Walker
Keyword(s):  
Informed Consent ◽  
Randomised Controlled Trial ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Randomised Controlled

Randomised controlled trial of whether erotic material is required for semen collection: impact of informed consent on outcome

Andrology ◽  
2013 ◽  
Vol 1 (6) ◽  
pp. 943-947 ◽  
Author(s):  
D. J. Handelsman ◽  
T. Sivananathan ◽  
L. Andres ◽  
F. Bathur ◽  
V. Jayadev ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Semen Collection ◽  
Randomised Controlled

SP7.2.4 Evaluation of Non-crosslinked Acellular Porcine Dermal Mesh – A Single Centre Experience

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Rama Karri ◽  
Amaar Aamery ◽  
Deepak Singh-Ranger
Keyword(s):  
Chronic Pain ◽  
Incisional Hernia ◽  
Abdominal Wall ◽  
Parastomal Hernia ◽  
Abdominal Wall Reconstruction ◽  
Hernia Recurrence ◽  
Biological Mesh ◽  
Ease Of Use ◽  
Secondary Outcome ◽  
Retrospective Case

Abstract Aims We report our experience with a cellular porcine dermal non-crosslinked biological mesh (EGIS®). We conducted a review of indications and outcomes of patients requiring the mesh for incisional hernia/complex abdominal wall reconstruction with component separation, parastomal hernia repairs and ELAPE. Patients were followed for a minimum of 6 and assessed for recurrence, seroma formation and chronic pain. Secondary outcome was the assessment of ease of use by the Surgeon – suturing and pliability. Method A retrospective case notes review of patients requiring biological mesh (EGIS®) from 2016 to present. A qualitative survey about ease of use of EGIS® for operations studied was sent to all Consultant Surgeons. Results EGIS® mesh was used in 38 patients: 23 Hernia repairs – 13 Incisional, 8 Parastomal, 2 Paraumbilical; 12 Pelvic floor repairs after ELAPE; and 3 abdominal wall reconstructions. Hernia recurrence occurred in 12 (32%), seroma 7 (18%) and chronic pain 7 (18%). The highest complications occurred in the incisional and parastomal hernia groups. Incisional hernia: recurrence in 5 (38%), seroma in 5 (38%) and chronic pain in 3 (23%). Parastomal hernia: recurrence in 3 (38%), chronic pain 2 (25%), seroma 1 (13%). Consultants scored the mesh 4.3 to 4.5 out of 10 for pliability, ease of use and suturing. Conclusion Biological mesh is used to reinforce hernia repairs in contaminated or potentially contaminated fields. Non-crosslinked meshes are preferred for their greater cellular infiltration from host tissue with improved integration. Our experience with this mesh shows a high complication rate and requires re-evaluation.

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