LaparotomyREBUILDNCT05041530
Abdominal Wall Closure After Laparotomy in Oncologic Surgery
A study testing REBUILD Bioabsorbable in people with Laparotomy, run by AbSolutions Med Inc. at 2 sites in Colombia.
Trial summary
The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laparotomy
- What is being tested?
- REBUILD Bioabsorbable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesColombia
- Study dates
- 17 Jun 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18-75 years of age
- Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy
- Patient is able to provide written informed consent
- Patient is able and willing to comply with all study requirements
Who cannot join
- Patient is scheduled for a palliative procedure
- Patient has had previous failed surgical repair of a ventral or incisional hernia
- Patient has a current infection at the intended surgical site
- Patient is participating in a concurrent investigational medical device study
- Patient is pregnant or planning on becoming pregnant during the study period
- Patient has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to be compliant with post-operative visits.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia2 sites, 2 recruiting
- Recruiting
Clinica Medellin
Medellín, Antioquia, 050025
Gloria Salazar, 574 444 61 52 ext. 256, gloria.salazar@clinicamedellin.com
Claudia Asela, 3166224596, danacaya51@gmail.com
- Recruiting
Clinica Las Americas
Medellín
Luis J Palacios Fuenmayor, MD, 57-310-737-9611, luis.palacios@lasamericas.com.co
Laura Lobo, 57-314-641-2839, laura.lobo@lasamericas.com.co
About this study
Official title: A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbable™ for Closure of the Abdominal Wall After Oncologic Laparotomy
The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.
Read the detailed 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.
- Conditions
- Laparotomy
- Being tested
- REBUILD Bioabsorbable
- Keywords
- Laparotomy, Abdominal Wall Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REBUILD BioabsorbableDevice
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures.
| Study group | Role | What they receive |
|---|---|---|
| REBUILD | Experimental | Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo oncologic laparotomy per the standard of care. The abdominal wall will be closed with REBUILD Bioabsorbable and suture of the surgeon's choice. Receives: Device: REBUILD Bioabsorbable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The number of device-related adverse events
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start17 Jun 2022
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, single-arm, feasibility study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbSolutions Med Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cogent Technologies Corporation
- Responsible party
- Sponsor
- Investigators
- Luis J Palacios Fuenmayor, MD, Principal investigator, Clinica Las Americas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041530
- Sponsor's protocol ID
- CTP-0001
- Acronym
- REBUILD
- Status last verified
- Dec 2022
- First submitted
- 3 Sep 2021
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27750295Flum 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.
PubMed 12496540Hawn 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.
PubMed 20421023Deeken 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.
PubMed 23781348Glauser 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.
PubMed 30824961Kohler 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.
PubMed 30476940San 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.
PubMed 30288617Jairam 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.
PubMed 28641875Muysoms 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.
PubMed 26943336Bali C, Papakostas J, Georgiou G, Kouvelos G, Avgos S, Arnaoutoglou E, Papadopoulos G, Matsagkas M. A comparative study of sutured versus bovine pericardium mesh abdominal closure after open abdominal aortic aneurysm repair. Hernia. 2015 Apr;19(2):267-71. doi: 10.1007/s10029-014-1262-4. Epub 2014 May 13.
PubMed 24820007Deerenberg 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.
PubMed 26188742Garcia-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.
PubMed 25575254Sarr 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.
PubMed 25239343Khorgami 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.
PubMed 22677612Curro G, Centorrino T, Low V, Sarra G, Navarra G. Long-term outcome with the prophylactic use of polypropylene mesh in morbidly obese patients undergoing biliopancreatic diversion. Obes Surg. 2012 Feb;22(2):279-82. doi: 10.1007/s11695-011-0486-y.
PubMed 21809056
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbable™ for Closure of the Abdominal Wall After Oncologic Laparotomy
- ClinicalTrials.gov ID
- NCT05041530
- Acronym / sponsor ID
- REBUILD / CTP-0001
- Conditions
- Laparotomy
- Keywords
- Laparotomy, Abdominal Wall Closure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AbSolutions Med Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cogent Technologies Corporation
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, single-arm, feasibility study
| Arm | Type | Receives |
|---|---|---|
| REBUILD | Experimental | Device: REBUILD BioabsorbableSubjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo oncologic laparotomy per the standard of care. The abdominal wall will be closed with REBUILD Bioabsorbable and suture of the surgeon's choice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is 18-75 years of age
- Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy
- Patient is able to provide written informed consent
- Patient is able and willing to comply with all study requirements
Key exclusion criteria (6 listed)
- Patient is scheduled for a palliative procedure
- Patient has had previous failed surgical repair of a ventral or incisional hernia
- Patient has a current infection at the intended surgical site
- Patient is participating in a concurrent investigational medical device study
- Patient is pregnant or planning on becoming pregnant during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REBUILD BioabsorbableREBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. | Device | REBUILD |
Primary outcome
Adverse Events
Time frame: 12 months
The number of device-related adverse events
Performance
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Background: PubMed 27750295Kokotovic 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.
- Background: PubMed 12496540Flum 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.
- Background: PubMed 20421023Hawn 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.
- Background: PubMed 23781348Deeken 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.
- Background: PubMed 30824961Glauser 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.
- Background: PubMed 30476940Kohler 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.
- Background: PubMed 30288617San 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.
- Background: PubMed 28641875Jairam 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.
- Background: PubMed 26943336Muysoms 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.
- Background: PubMed 24820007Bali C, Papakostas J, Georgiou G, Kouvelos G, Avgos S, Arnaoutoglou E, Papadopoulos G, Matsagkas M. A comparative study of sutured versus bovine pericardium mesh abdominal closure after open abdominal aortic aneurysm repair. Hernia. 2015 Apr;19(2):267-71. doi: 10.1007/s10029-014-1262-4. Epub 2014 May 13.
- Background: PubMed 26188742Deerenberg 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.
- Background: PubMed 25575254Garcia-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.
- American Society of Anesthesiologists Physical Status Classification SystemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis J Palacios Fuenmayor, MD principal investigator
Clinica Las Americas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REBUILD Bioabsorbable in people with Laparotomy, run by AbSolutions Med Inc. at 2 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Jacobs, MD (650-303-6140, danj@absolutionsmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05041530, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.