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COVID-19 pandemic and the halt to elective surgeries hindered enrollment; PI left insitution
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Half of all individuals will undergo abdominal surgery in their lifetime. Following abdominal surgery, 30% of patients will suffer a major chronic complication with their wound closure in the first post-operative year. This may include significant wound infections, open wounds, fluid collections, fascial dehiscence, or incisional hernia. These complications not only have a substantial impact on the health care system (cost and chronic disease) and the hospital (cost and space), but most importantly have a substantial impact on the patient. Major chronic wound complications adversely impact patient quality of life and function. Potential methods to reduce major wound complications include utilizing specific suturing techniques or reinforcing the incision line. Suturing technique of small-bites (0.5x0.5 cm bites) as opposed to large bites (1.0x1.0 cm bites) has been shown to be efficacious in European populations with a typical body mass index of 20-25 kg/m2. Tissue reinforcement has been shown to decrease rates of major wound complications in small randomized controlled trials.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biologic Mesh and Small Bites | Experimental | Biologic mesh placement and small bites used for suturing. |
|
| Small Bites and No Biologic Mesh | Experimental | Small bites used for suturing with no placement of biologic mesh |
|
| Biologic mesh and Large Bites | Experimental | Biologic mesh placement and large bites used for suturing |
|
| Large Bites and no biologic mesh | Active Comparator | Large bites used for suturing and no placement of biologic mesh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biologic Mesh | Device | Biologic mesh placed during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Major Chronic Wound Infection | Proportion of participants with major chronic wound infection | 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Complications | Major complications include surgical site infection, ventral incisional hernia, and/or reoperation | 1 year after surgery |
| Number of Participants With Surgical Site Infections |
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Inclusion Criteria:
All high-risk patients undergoing laparotomy or laparoscopic-assisted abdominal surgery. This includes:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Holihan, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B. Johnson (LBJ) Hospital | Houston | Texas | 77026 | United States | ||
| The University of Texas Health Science Center at Houston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25690673 | Background | 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. | |
| 24680572 |
| Label | URL |
|---|---|
| Guidelines for surgical site infections | View source |
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Of the 163 participants enrolled, 107 met inclusion criteria and were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Small Bites and No Biologic Mesh |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Major Chronic Wound Infection | Proportion of participants with major chronic wound infection | Data were not collected for this outcome measure. | Posted | 1 year after surgery |
|
1 year post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reoperation | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventral incisional hernia | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Holihan, MD | The University of Texas Health Science Center at Houston | 713-500-7188 | Julie.L.Holihan@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2020 | Jun 16, 2022 | Prot_SAP_000.pdf |
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| Small Bites | Procedure | 0.5 cm x 0.5 cm sutures used |
|
| Large Bites | Procedure | 1.0 x 1.0 sutures used |
|
| 1 year after surgery |
| Number of Participants With Reoperations | any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity | 1 year after surgery |
| Operative Duration | length of the entire procedure | about 119 minutes to 337 minutes |
| Participants Quality of Life as Assessed by Activities Assessment Scale | Quality of life is scored from 1 to 100, where the higher the score the higher quality of life | 1 year after surgery |
| Participants Health Status as Assessed by the Euroqol-5D Questionnaire | Health Status is scored from 0 to 100, where the higher the score the better the health | 1 year after surgery |
| Cost Analyses | calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures | 1 year after surgery |
| Surgeon Perception | likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial | 1 year after surgery |
| Number of Participants With Major Complications | Major complications include surgical site infection, ventral incisional hernia, and/or reoperation | 3 years after surgery |
| Number of Participants With Surgical Site Infections | 3 years after surgery |
| Number of Participants With Reoperations | any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity | 3 years after surgery |
| Participants Quality of Life as Assessed by Activities Assessment Scale | Quality of life is scored from 1 to 100, where the higher the score the higher quality of life | 3 years after surgery |
| Participants Health Status as Assessed by the Euroqol-5D Questionnaire | Health Status is scored from 0 to 100, where the higher the score the better the health | 3 years after surgery |
| Cost Analyses | calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures | 3 years after surgery |
| Surgeon Perception | likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial | 3 years after surgery |
| Houston |
| Texas |
| 77030 |
| United States |
| Background |
| 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. |
| 16038812 | Background | 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. |
| 16904970 | Background | 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. |
| 2777368 | Background | 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. |
| 27355269 | Background | 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. |
| 26188742 | Background | 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. |
| 19917943 | Background | 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. |
| 21279664 | Background | 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. |
| 23712289 | Background | 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. |
| 26557646 | Background | 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. |
| 26943336 | Background | 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. |
| 25239343 | Background | 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. |
| 24820007 | Background | 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. |
| 24229031 | Background | 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. |
| 4023472 | Background | 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. |
| 37458369 | Derived | 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. |
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| 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 |
| OG003 | 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 |
|
| Secondary | Number of Participants With Major Complications | Major complications include surgical site infection, ventral incisional hernia, and/or reoperation | Posted | Count of Participants | Participants | 1 year after surgery |
|
|
|
| Secondary | Number of Participants With Surgical Site Infections | Posted | Count of Participants | Participants | 1 year after surgery |
|
|
|
| Secondary | Number of Participants With Reoperations | any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity | Posted | Count of Participants | Participants | 1 year after surgery |
|
|
|
| Secondary | Operative Duration | length of the entire procedure | Posted | Mean | Standard Deviation | minutes | about 119 minutes to 337 minutes |
|
|
|
| Secondary | Participants Quality of Life as Assessed by Activities Assessment Scale | Quality of life is scored from 1 to 100, where the higher the score the higher quality of life | Data were not collected for 13 participants in the Biologic Mesh arm. Data were not collected for 10 participants in the No Biologic Mesh arm. Data were not collected for 7 participants in the Large Bites arm. Data were not collected for 16 participants in the Small Bites arm. | Posted | Mean | Standard Deviation | score on a scale | 1 year after surgery |
|
|
|
| Secondary | Participants Health Status as Assessed by the Euroqol-5D Questionnaire | Health Status is scored from 0 to 100, where the higher the score the better the health | Data were not collected for 13 participants in the Biologic Mesh arm. Data were not collected for 10 participants in the No Biologic Mesh arm. Data were not collected for 7 participants in the Large Bites arm. Data were not collected for 16 participants in the Small Bites arm | Posted | Median | Inter-Quartile Range | score on a scale | 1 year after surgery |
|
|
|
| Secondary | Cost Analyses | calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures | Data were not collected for this outcome measure. | Posted | 1 year after surgery |
|
|
| Secondary | Surgeon Perception | likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial | Data were not collected for this outcome measure. | Posted | 1 year after surgery |
|
|
| Secondary | Number of Participants With Major Complications | Major complications include surgical site infection, ventral incisional hernia, and/or reoperation | Data were not collected for this outcome measure. | Posted | 3 years after surgery |
|
|
| Secondary | Number of Participants With Surgical Site Infections | Data were not collected for this outcome measure. | Posted | 3 years after surgery |
|
|
| Secondary | Number of Participants With Reoperations | any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity | Data were not collected for this outcome measure. | Posted | 3 years after surgery |
|
|
| Secondary | Participants Quality of Life as Assessed by Activities Assessment Scale | Quality of life is scored from 1 to 100, where the higher the score the higher quality of life | Data were not collected for this outcome measure. | Posted | 3 years after surgery |
|
|
| Secondary | Participants Health Status as Assessed by the Euroqol-5D Questionnaire | Health Status is scored from 0 to 100, where the higher the score the better the health | Data were not collected for this outcome measure. | Posted | 3 years after surgery |
|
|
| Secondary | Cost Analyses | calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures | Data were not collected for this outcome measure. | Posted | 3 years after surgery |
|
|
| Secondary | Surgeon Perception | likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial | Data were not collected for this outcome measure. | Posted | 3 years after surgery |
|
|
| 0 |
| 27 |
| 2 |
| 27 |
| 4 |
| 27 |
| EG001 | 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 | 0 | 28 | 1 | 28 | 5 | 28 |
| EG002 | 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 | 0 | 25 | 2 | 25 | 5 | 25 |
| EG003 | 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 | 0 | 27 | 2 | 27 | 2 | 27 |
| Bowel Obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Surgical Site Infection | Infections and infestations | Non-systematic Assessment |
|
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