Wound ComplicationNCT03148496
Tissue Reinforcement of Incisional Closure Among High Risk Patients
A study testing Biologic Mesh, Small Bites and Large Bites in people with Wound Complication, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Complication
- What is being tested?
- Biologic Mesh, Small Bites and Large Bites
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2017to 19 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All high-risk patients undergoing laparotomy or laparoscopic-assisted abdominal surgery. This includes:
- all overweight patients (BMI>=25 kg/m2),
- current smokers,
- those who are immunosuppressed,
- those who are malnourished, or
- those who are undergoing a contaminated case (CDC wound classification of 2 or 3).
Who cannot join
- patients unlikely to follow-up in a year (e.g. no phone or lives out of state),
- patients unlikely to survive more than 2 years based upon surgeon judgment (e.g. metastatic cancer, end-stage cirrhosis),
- patients where the clinician would not place prosthetic (e.g. pregnant patient, pediatric patient during growth stage),
- patient has a planned second surgery within the next year (e.g. ostomy reversal).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson (LBJ) Hospital
Houston, Texas, 77026
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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:
- 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.
- 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.
- Conditions
- Wound Complication
- Being tested
- Biologic Mesh, Small Bites, Large Bites
- Keywords
- abdominal surgery, wound complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic MeshDevice
Biologic mesh placed during surgery
Small BitesProcedure or surgery
0.5 cm x 0.5 cm sutures used
Large BitesProcedure or surgery
1.0 x 1.0 sutures used
| Study group | Role | What they receive |
|---|---|---|
| Biologic Mesh and Small Bites | Experimental | Biologic mesh placement and small bites used for suturing. Receives: Device: Biologic Mesh; Procedure: Small Bites |
| Small Bites and No Biologic Mesh | Experimental | Small bites used for suturing with no placement of biologic mesh Receives: Procedure: Small Bites |
| Biologic mesh and Large Bites | Experimental | Biologic mesh placement and large bites used for suturing Receives: Device: Biologic Mesh; Procedure: Large Bites |
| Large Bites and no biologic mesh | Active comparator | Large bites used for suturing and no placement of biologic mesh. Receives: Procedure: Large Bites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Major Chronic Wound Infection
Proportion of participants with major chronic wound infection
Measured: 1 year after surgery
Secondary outcomes (15)
Number of Participants With Major Complications
Major complications include surgical site infection, ventral incisional hernia, and/or reoperation
Measured: 1 year after surgery
Number of Participants With Surgical Site Infections
Measured: 1 year after surgery
Number of Participants With Reoperations
any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity
Measured: 1 year after surgery
Operative Duration
length of the entire procedure
Measured: 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
Measured: 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
Measured: 1 year after surgery
Cost Analyses
calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures
Measured: 1 year after surgery
Surgeon Perception
likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial
Measured: 1 year after surgery
Number of Participants With Major Complications
Major complications include surgical site infection, ventral incisional hernia, and/or reoperation
Measured: 3 years after surgery
Number of Participants With Surgical Site Infections
Measured: 3 years after surgery
Number of Participants With Reoperations
any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity
Measured: 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
Measured: 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
Measured: 3 years after surgery
Cost Analyses
calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures
Measured: 3 years after surgery
Surgeon Perception
likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start13 Sep 2017
- Primary completion19 Jun 2021
- Study completion19 Jun 2021
Why it stopped: COVID-19 pandemic and the halt to elective surgeries hindered enrollment; PI left insitution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Holihan, The University of Texas Health Science Center, Houston
- Investigators
- Julie Holihan, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148496
- Sponsor's protocol ID
- HSC-MS-17-0063
- Status last verified
- Jul 2022
- First submitted
- 5 May 2017
- Last updated
- 22 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25690673Armananzas 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.
PubMed 24680572McCarthy 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.
PubMed 16038812Hawn 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.
PubMed 16904970Blackstock 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.
PubMed 2777368Holihan 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.
PubMed 27355269Deerenberg 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 26188742Millbourn 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.
PubMed 19917943Millbourn 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.
PubMed 21279664Bhangu 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.
PubMed 23712289Fortelny 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.
PubMed 26557646Muysoms 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 26943336Sarr 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 25239343Bali 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 24820007Ferzoco 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.
PubMed 24229031
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Reinforcement of Incisional Closure Among High Risk Patients
- ClinicalTrials.gov ID
- NCT03148496
- Acronym / sponsor ID
- HSC-MS-17-0063
- Conditions
- Wound Complication
- Keywords
- abdominal surgery, wound complication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic and the halt to elective surgeries hindered enrollment; PI left insitution
- Enrolment
- 163 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 19 Jun 2021 (actual)
- Study completion
- 19 Jun 2021 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Posted 22 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biologic Mesh and Small Bites | Experimental | Device: Biologic Mesh, Procedure: Small BitesBiologic mesh placement and small bites used for suturing. |
| Small Bites and No Biologic Mesh | Experimental | Procedure: Small BitesSmall bites used for suturing with no placement of biologic mesh |
| Biologic mesh and Large Bites | Experimental | Device: Biologic Mesh, Procedure: Large BitesBiologic mesh placement and large bites used for suturing |
| Large Bites and no biologic mesh | Active comparator | Procedure: Large BitesLarge bites used for suturing and no placement of biologic mesh. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All high-risk patients undergoing laparotomy or laparoscopic-assisted abdominal surgery. This includes:
- all overweight patients (BMI>=25 kg/m2),
- current smokers,
- those who are immunosuppressed,
- those who are malnourished, or
Key exclusion criteria (4 listed)
- patients unlikely to follow-up in a year (e.g. no phone or lives out of state),
- patients unlikely to survive more than 2 years based upon surgeon judgment (e.g. metastatic cancer, end-stage cirrhosis),
- patients where the clinician would not place prosthetic (e.g. pregnant patient, pediatric patient during growth stage),
- patient has a planned second surgery within the next year (e.g. ostomy reversal).
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 |
|---|---|---|
| Biologic MeshBiologic mesh placed during surgery | Device | Biologic Mesh and Small Bites, Biologic mesh and Large Bites |
| Small Bites0.5 cm x 0.5 cm sutures used | Procedure or surgery | Biologic Mesh and Small Bites, Small Bites and No Biologic Mesh |
| Large Bites1.0 x 1.0 sutures used | Procedure or surgery | Biologic mesh and Large Bites, Large Bites and no biologic mesh |
Primary outcome
Proportion of Participants Major Chronic Wound Infection
Time frame: 1 year after surgery
Proportion of participants with major chronic wound infection
15 secondary outcomes
Number of Participants With Major Complications
Time frame: 1 year after surgery
Number of Participants With Surgical Site Infections
Time frame: 1 year after surgery
Number of Participants With Reoperations
Time frame: 1 year after surgery
Operative Duration
Time frame: about 119 minutes to 337 minutes
Participants Quality of Life as Assessed by Activities Assessment Scale
Time frame: 1 year after surgery
Participants Health Status as Assessed by the Euroqol-5D Questionnaire
Time frame: 1 year after surgery
Cost Analyses
Time frame: 1 year after surgery
Surgeon Perception
Time frame: 1 year after surgery
Number of Participants With Major Complications
Time frame: 3 years after surgery
Number of Participants With Surgical Site Infections
Time frame: 3 years after surgery
Number of Participants With Reoperations
Time frame: 3 years after surgery
Participants Quality of Life as Assessed by Activities Assessment Scale
Time frame: 3 years after surgery
Participants Health Status as Assessed by the Euroqol-5D Questionnaire
Time frame: 3 years after surgery
Cost Analyses
Time frame: 3 years after surgery
Surgeon Perception
Time frame: 3 years after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25690673Goodenough 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.
- Background: PubMed 24680572Armananzas 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.
- Background: PubMed 16038812McCarthy 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.
- Background: PubMed 16904970Hawn 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.
- Background: PubMed 2777368Blackstock 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.
- Background: PubMed 27355269Holihan 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.
- 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 19917943Millbourn 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.
- Background: PubMed 21279664Millbourn 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.
- Background: PubMed 23712289Bhangu 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.
- Background: PubMed 26557646Fortelny 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.
- 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.
- Guidelines for surgical site infectionsLink 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. This study is not recruiting at the moment.
Julie Holihan, MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biologic Mesh, Small Bites and Large Bites in people with Wound Complication, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Major Chronic Wound Infection (time frame: 1 year after surgery). 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 NCT03148496, which also lists 17 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 22 Jul 2022.