Tissue Reinforcement of Incisional Closure Among High Risk Patients

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:

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.

Study Overview

• Status: Terminated
• Conditions: Wound Complication
• Intervention / Treatment: Device: Biologic Mesh; Procedure: Small Bites; Procedure: Large Bites

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77026
      • Lyndon B. Johnson (LBJ) Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All high-risk patients undergoing laparotomy or laparoscopic-assisted abdominal surgery. This includes:

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:

1. patients unlikely to follow-up in a year (e.g. no phone or lives out of state),
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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biologic Mesh and Small Bites; Biologic mesh placement and small bites used for suturing.	Device: Biologic Mesh; Biologic mesh placed during surgery; Procedure: Small Bites; 0.5 cm x 0.5 cm sutures used
Experimental: Small Bites and No Biologic Mesh; Small bites used for suturing with no placement of biologic mesh	Procedure: Small Bites; 0.5 cm x 0.5 cm sutures used
Experimental: Biologic mesh and Large Bites; Biologic mesh placement and large bites used for suturing	Device: Biologic Mesh; Biologic mesh placed during surgery; Procedure: Large Bites; 1.0 x 1.0 sutures used
Active Comparator: Large Bites and no biologic mesh; Large bites used for suturing and no placement of biologic mesh.	Procedure: Large Bites; 1.0 x 1.0 sutures used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Major Chronic Wound Infection	Proportion of participants with major chronic wound infection	1 year after surgery

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Julie Holihan, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: J Am Coll Surg. 2005 Nov;201(5):826.
• 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. 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.

Helpful Links

• Guidelines for surgical site infections

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Actual): June 19, 2021
• Study Completion (Actual): June 19, 2021

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: abdominal surgery; wound complication
• Other Study ID Numbers: HSC-MS-17-0063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes