Abdominal Wall Closure After Laparotomy in Oncologic Surgery

Laparotomy Clinical Trial

— REBUILD  

Official title:

A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbable™ for Closure of the Abdominal Wall After Oncologic Laparotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05041530
• Other study ID #: CTP-0001
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: AbSolutions Med Inc.
• Contact: Daniel Jacobs, MD
• Phone: 650-303-6140
• Email: danj[@]absolutionsmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.

Description:

REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. In this study, REBUILD will be used in oncology patients undergoing an open, elective, intent-to-cure, laparotomy procedure. The study is a prospective, non-randomized, multi-center study designed to generate descriptive data about the use of REBUILD. The primary safety outcome is reported device-related adverse events. The primary performance outcome is the integrity of the abdominal wall over one year assessed by clinical examination of the abdomen. If available, CT studies performed within 12 months post-procedure will be used to confirm apposition of the medial border of the rectus muscles and integrity of the abdominal wall.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patient is 18-75 years of age

2. Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy

3. Patient is able to provide written informed consent

4. Patient is able and willing to comply with all study requirements

Exclusion Criteria:

1. Patient is scheduled for a palliative procedure

2. Patient has had previous failed surgical repair of a ventral or incisional hernia

3. Patient has a current infection at the intended surgical site

4. Patient is participating in a concurrent investigational medical device study

5. Patient is pregnant or planning on becoming pregnant during the study period

6. Patient has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to be compliant with post-operative visits.

Related Conditions & MeSH terms

• Laparotomy

Intervention

Device:
• REBUILD Bioabsorbable
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures.

Locations

Country	Name	City	State
Colombia	Clinica Las Americas	Medellin
Colombia	Clinica Medellin	Medellín	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
AbSolutions Med Inc.	Cogent Technologies Corporation

Country where clinical trial is conducted

Colombia, 

References & Publications (27)

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Deeken CR, Matthews BD. Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate-PHASIX Mesh) in a Porcine Model of Hernia Repair. ISRN Surg. 2013 May 28;2013:238067. doi: 10.1155/2013/238067. Print 2013. — View Citation

Deerenberg EB, Harlaar JJ, Steyerberg EW, Lont HE, van Doorn HC, Heisterkamp J, Wijnhoven BP, Schouten WR, Cense HA, Stockmann HB, Berends FJ, Dijkhuizen FPH, Dwarkasing RS, Jairam AP, van Ramshorst GH, Kleinrensink GJ, Jeekel J, Lange JF. Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1254-1260. doi: 10.1016/S0140-6736(15)60459-7. Epub 2015 Jul 15. — View Citation

El-Khadrawy OH, Moussa G, Mansour O, Hashish MS. Prophylactic prosthetic reinforcement of midline abdominal incisions in high-risk patients. Hernia. 2009 Jun;13(3):267-74. doi: 10.1007/s10029-009-0484-3. Epub 2009 Mar 5. — View Citation

Flum DR, Horvath K, Koepsell T. Have outcomes of incisional hernia repair improved with time? A population-based analysis. Ann Surg. 2003 Jan;237(1):129-35. doi: 10.1097/00000658-200301000-00018. — View Citation

Garcia-Urena MA, Lopez-Monclus J, Hernando LA, Montes DM, Valle de Lersundi AR, Pavon CC, Ceinos CJ, Quindos PL. Randomized controlled trial of the use of a large-pore polypropylene mesh to prevent incisional hernia in colorectal surgery. Ann Surg. 2015 May;261(5):876-81. doi: 10.1097/SLA.0000000000001116. — View Citation

Glauser PM, Brosi P, Speich B, Kaser SA, Heigl A, Rosenberg R, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1669-1675. doi: 10.1007/s00268-019-04964-6. Erratum In: World J Surg. 2019 Mar 29;: — View Citation

Harlaar JJ, Deerenberg EB, Dwarkasing RS, Kamperman AM, Kleinrensink GJ, Jeekel J, Lange JF. Development of incisional herniation after midline laparotomy. BJS Open. 2017 May 10;1(1):18-23. doi: 10.1002/bjs5.3. eCollection 2017 Feb. — View Citation

Hawn MT, Snyder CW, Graham LA, Gray SH, Finan KR, Vick CC. Long-term follow-up of technical outcomes for incisional hernia repair. J Am Coll Surg. 2010 May;210(5):648-55, 655-7. doi: 10.1016/j.jamcollsurg.2009.12.038. — View Citation

Henriksen NA, Deerenberg EB, Venclauskas L, Fortelny RH, Miserez M, Muysoms FE. Meta-analysis on Materials and Techniques for Laparotomy Closure: The MATCH Review. World J Surg. 2018 Jun;42(6):1666-1678. doi: 10.1007/s00268-017-4393-9. — View Citation

Jairam AP, Timmermans L, Eker HH, Pierik REGJM, van Klaveren D, Steyerberg EW, Timman R, van der Ham AC, Dawson I, Charbon JA, Schuhmacher C, Mihaljevic A, Izbicki JR, Fikatas P, Knebel P, Fortelny RH, Kleinrensink GJ, Lange JF, Jeekel HJ; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial. Lancet. 2017 Aug 5;390(10094):567-576. doi: 10.1016/S0140-6736(17)31332-6. Epub 2017 Jun 20. Erratum In: Lancet. 2017 Aug 5;390(10094):554. — View Citation

Khorgami Z, Shoar S, Laghaie B, Aminian A, Hosseini Araghi N, Soroush A. Prophylactic retention sutures in midline laparotomy in high-risk patients for wound dehiscence: a randomized controlled trial. J Surg Res. 2013 Apr;180(2):238-43. doi: 10.1016/j.jss.2012.05.012. Epub 2012 May 24. — View Citation

Kohler A, Lavanchy JL, Lenoir U, Kurmann A, Candinas D, Beldi G. Effectiveness of Prophylactic Intraperitoneal Mesh Implantation for Prevention of Incisional Hernia in Patients Undergoing Open Abdominal Surgery: A Randomized Clinical Trial. JAMA Surg. 2019 Feb 1;154(2):109-115. doi: 10.1001/jamasurg.2018.4221. — View Citation

Kokotovic D, Bisgaard T, Helgstrand F. Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair. JAMA. 2016 Oct 18;316(15):1575-1582. doi: 10.1001/jama.2016.15217. — View Citation

Muysoms FE, Detry O, Vierendeels T, Huyghe M, Miserez M, Ruppert M, Tollens T, Defraigne JO, Berrevoet F. Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: A Randomized Controlled Trial. Ann Surg. 2016 Apr;263(4):638-45. doi: 10.1097/SLA.0000000000001369. — View Citation

Nenshi R, Bensimon C, Wood T, Wright F, Smith AJ, Brenneman F. Complex abdominal wall hernias as a barrier to quality of life in cancer survivors. Can J Surg. 2019 Mar 22;62(3):1-7. doi: 10.1503/cjs.014917. Online ahead of print. — View Citation

Onyekwelu I, Yakkanti R, Protzer L, Pinkston CM, Tucker C, Seligson D. Surgical Wound Classification and Surgical Site Infections in the Orthopaedic Patient. J Am Acad Orthop Surg Glob Res Rev. 2017 Jun 13;1(3):e022. doi: 10.5435/JAAOSGlobal-D-17-00022. eCollection 2017 Jun. — View Citation

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San Miguel C, Melero D, Jimenez E, Lopez P, Robin A, Blazquez LA, Lopez-Monclus J, Gonzalez E, Jimenez C, Garcia-Urena MA. Long-term outcomes after prophylactic use of onlay mesh in midline laparotomy. Hernia. 2018 Dec;22(6):1113-1122. doi: 10.1007/s10029-018-1833-x. Epub 2018 Oct 4. — View Citation

Sarr MG, Hutcher NE, Snyder S, Hodde J, Carmody B. A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery. Surgery. 2014 Oct;156(4):902-8. doi: 10.1016/j.surg.2014.06.022. — View Citation

Taylor DA, Merten SL, Sandercoe GD, Gahankari D, Ingram SB, Moncrieff NJ, Ho K, Sellars GD, Magnusson MR. Abdominoplasty Improves Low Back Pain and Urinary Incontinence. Plast Reconstr Surg. 2018 Mar;141(3):637-645. doi: 10.1097/PRS.0000000000004100. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	The number of device-related adverse events	12 months
Primary	Performance	The number of subjects with abdominal wall integrity at 3-, 6-, and 12-months post-surgery. Abdominal wall integrity will be assessed via clinical examination of the abdomen to identify a fascial defect, bulge, reducible palpable mass, or discomfort with a cough impulse. Standard of care CT or MR imaging that is performed within 12 months of the surgery will be evaluated to confirm apposition of the medial border of the rectus abdominis muscles and integrity of the abdominal wall.	12 months

External Links

•   American Society of Anesthesiologists Physical Status Classification System