Tissue Reinforcement of Incisional Closure Among High Risk Patients

Wound Complication Clinical Trial

Official title:

Tissue Reinforcement of Incisional Closure Among High Risk Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03148496
• Other study ID #: HSC-MS-17-0063
• Status: Terminated
• Phase: N/A
• Start date: September 13, 2017
• Est. completion date: June 19, 2021

Study information

• Verified date: July 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 163
• Est. completion date: June 19, 2021
• Est. primary completion date: June 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Wound Complication

Intervention

Device:
• Biologic Mesh
Biologic mesh placed during surgery

Procedure:
• Small Bites
0.5 cm x 0.5 cm sutures used
• Large Bites
1.0 x 1.0 sutures used

Locations

Country	Name	City	State
United States	Lyndon B. Johnson (LBJ) Hospital	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (16)

Armañanzas L, Ruiz-Tovar J, Arroyo A, García-Peche P, Armañanzas 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. — View Citation

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. — View Citation

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. Review. — View Citation

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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

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. Review. — View Citation

Fortelny RH, Hofmann A, May C, Köckerling 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: J Am Coll Surg. 2005 Nov;201(5):826. — View Citation

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. — View Citation

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. — 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

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

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* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Major Chronic Wound Infection	Proportion of participants with major chronic wound infection	1 year after surgery
Secondary	Number of Participants With Major Complications	Major complications include surgical site infection, ventral incisional hernia, and/or reoperation	1 year after surgery
Secondary	Number of Participants With Surgical Site Infections		1 year after surgery
Secondary	Number of Participants With Reoperations	any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity	1 year after surgery
Secondary	Operative Duration	length of the entire procedure	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	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	1 year after surgery
Secondary	Cost Analyses	calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures	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	1 year after surgery
Secondary	Number of Participants With Major Complications	Major complications include surgical site infection, ventral incisional hernia, and/or reoperation	3 years after surgery
Secondary	Number of Participants With Surgical Site Infections		3 years after surgery
Secondary	Number of Participants With Reoperations	any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity	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	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	3 years after surgery
Secondary	Cost Analyses	calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures	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	3 years after surgery

External Links

•   Guidelines for surgical site infections