Tissue Reinforcement of Incisional Closure Among High Risk Patients
NCT ID: NCT03148496
Last Updated: 2022-07-22
Study Results
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View full resultsBasic Information
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TERMINATED
NA
163 participants
INTERVENTIONAL
2017-09-13
2021-06-19
Brief Summary
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However, the lack of widespread adoption of these practices may be due to issues of generalizability including strict inclusion criteria, careful patient selection, and small study size. For example, the generalizability of small bites to an overweight population (mean BMI in the United States is 28 kg/m2) as opposed to a normal-weight population are unclear. The use of synthetic materials in comorbid patients or complex settings may risk major wound complications such as prosthetic infection. Biologic materials have been shown to be effective in decreasing major wound complications but in different settings. This study is being done to assess the effectiveness of different efficacious strategies to decrease the rate of major wound complications following abdominal surgery among high-risk individuals The researchers hypothesize:
1. Among high-risk patients undergoing abdominal surgery, the use of "small-bites" closure as opposed to "large-bites" closure will increase the proportion of patients who are free of major, chronic wound complications at 1-year post-operative.
2. Among high-risk patients undergoing abdominal surgery, the biologic tissue reinforcement of the suture line as opposed to no reinforcement will increase the proportion of patients who are free of major, chronic wound complications at 1-year post-operative.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Biologic Mesh and Small Bites
Biologic mesh placement and small bites used for suturing.
Biologic Mesh
Biologic mesh placed during surgery
Small Bites
0.5 cm x 0.5 cm sutures used
Small Bites and No Biologic Mesh
Small bites used for suturing with no placement of biologic mesh
Small Bites
0.5 cm x 0.5 cm sutures used
Biologic mesh and Large Bites
Biologic mesh placement and large bites used for suturing
Biologic Mesh
Biologic mesh placed during surgery
Large Bites
1.0 x 1.0 sutures used
Large Bites and no biologic mesh
Large bites used for suturing and no placement of biologic mesh.
Large Bites
1.0 x 1.0 sutures used
Interventions
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Biologic Mesh
Biologic mesh placed during surgery
Small Bites
0.5 cm x 0.5 cm sutures used
Large Bites
1.0 x 1.0 sutures used
Eligibility Criteria
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Inclusion Criteria
1. all overweight patients (BMI\>=25 kg/m2),
2. current smokers,
3. those who are immunosuppressed,
4. those who are malnourished, or
5. those who are undergoing a contaminated case (CDC wound classification of 2 or 3).
Exclusion Criteria
2. patients unlikely to survive more than 2 years based upon surgeon judgment (e.g. metastatic cancer, end-stage cirrhosis),
3. patients where the clinician would not place prosthetic (e.g. pregnant patient, pediatric patient during growth stage),
4. patient has a planned second surgery within the next year (e.g. ostomy reversal).
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Julie Holihan
Assistant Professor of Surgery-Clinical
Principal Investigators
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Julie Holihan, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Lyndon B. Johnson (LBJ) Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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Goodenough CJ, Ko TC, Kao LS, Nguyen MT, Holihan JL, Alawadi Z, Nguyen DH, Flores JR, Arita NT, Roth JS, Liang MK. Development and validation of a risk stratification score for ventral incisional hernia after abdominal surgery: hernia expectation rates in intra-abdominal surgery (the HERNIA Project). J Am Coll Surg. 2015 Apr;220(4):405-13. doi: 10.1016/j.jamcollsurg.2014.12.027. Epub 2015 Jan 2.
Armananzas L, Ruiz-Tovar J, Arroyo A, Garcia-Peche P, Armananzas E, Diez M, Galindo I, Calpena R. Prophylactic mesh vs suture in the closure of the umbilical trocar site after laparoscopic cholecystectomy in high-risk patients for incisional hernia. A randomized clinical trial. J Am Coll Surg. 2014 May;218(5):960-8. doi: 10.1016/j.jamcollsurg.2014.01.049. Epub 2014 Feb 18.
McCarthy M Jr, Jonasson O, Chang CH, Pickard AS, Giobbie-Hurder A, Gibbs J, Edelman P, Fitzgibbons R, Neumayer L. Assessment of patient functional status after surgery. J Am Coll Surg. 2005 Aug;201(2):171-8. doi: 10.1016/j.jamcollsurg.2005.03.035.
Hawn MT, Itani KM, Giobbie-Hurder A, McCarthy M Jr, Jonasson O, Neumayer LA. Patient-reported outcomes after inguinal herniorrhaphy. Surgery. 2006 Aug;140(2):198-205. doi: 10.1016/j.surg.2006.02.003.
Blackstock R, Hernandez NC. Characterization of the macrophage subset affected and its response to a T suppressor factor (TsFmp) found in cryptococcosis. Infect Immun. 1989 Oct;57(10):2931-7. doi: 10.1128/iai.57.10.2931-2937.1989.
Holihan JL, Henchcliffe BE, Mo J, Flores-Gonzalez JR, Ko TC, Kao LS, Liang MK. Is Nonoperative Management Warranted in Ventral Hernia Patients With Comorbidities?: A Case-matched, Prospective, Patient-centered Study. Ann Surg. 2016 Oct;264(4):585-90. doi: 10.1097/SLA.0000000000001865.
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.
Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009 Nov;144(11):1056-9. doi: 10.1001/archsurg.2009.189.
Millbourn D, Cengiz Y, Israelsson LA. Risk factors for wound complications in midline abdominal incisions related to the size of stitches. Hernia. 2011 Jun;15(3):261-6. doi: 10.1007/s10029-010-0775-8. Epub 2011 Jan 30.
Bhangu A, Fitzgerald JE, Singh P, Battersby N, Marriott P, Pinkney T. Systematic review and meta-analysis of prophylactic mesh placement for prevention of incisional hernia following midline laparotomy. Hernia. 2013 Aug;17(4):445-55. doi: 10.1007/s10029-013-1119-2. Epub 2013 May 28.
Fortelny RH, Hofmann A, May C, Kockerling F; BioMesh Study Group. Prevention of a Parastomal Hernia by Biological Mesh Reinforcement. Front Surg. 2015 Oct 22;2:53. doi: 10.3389/fsurg.2015.00053. eCollection 2015.
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.
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.
Bali 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.
Ferzoco SJ. A systematic review of outcomes following repair of complex ventral incisional hernias with biologic mesh. Int Surg. 2013 Oct-Dec;98(4):399-408. doi: 10.9738/INTSURG-D-12-00002.1.
Stampfer MJ, Buring JE, Willett W, Rosner B, Eberlein K, Hennekens CH. The 2 x 2 factorial design: its application to a randomized trial of aspirin and carotene in U.S. physicians. Stat Med. 1985 Apr-Jun;4(2):111-6. doi: 10.1002/sim.4780040202.
Coelho R, Dhanani NH, Lyons NB, Bernardi K, Askenasy EP, Millas S, Holihan JL, Ali Z, Liang MK. Hernia Prevention Using Biologic Mesh and/or Small Bites: A Multispecialty 2 x 2 Factorial Randomized Controlled Trial. J Am Coll Surg. 2023 Aug 1;237(2):309-317. doi: 10.1097/XCS.0000000000000705. Epub 2023 Apr 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-17-0063
Identifier Type: -
Identifier Source: org_study_id
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