CClinicalTrials.gg
TerminatedNCT01295125DavolUpdated Jan 25, 2023Results posted

Comparative Study of Biologic Mesh Versus Repair With Component Separation.

An interventional study of XenMATRIX mesh and Open abdominal ventral hernia repair in Ventral Hernia, sponsored by University Hospitals Cleveland Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment

Why this study was terminated
Sponsor chose not to move forward with study
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare open abdominal incisional hernia repair using XenMATRIX biologic mesh versus repair with their own tissue. This study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia.

Read the detailed description

This study will involve comparison of open abdominal incisional hernia repair with XenMATRIX biologic graft versus repair with native tissue.

The current study seeks to evaluate XenMATRIXTM, an FDA approved biologic graft for repairing contaminated abdominal wall defects.

This study will provide significant insight for the reconstructive surgeon and patient to determine whether a biologic graft is necessary for the reconstruction of a contaminated ventral hernia repair to provide a durable single staged repair.

02

Conditions studied

  • Ventral Hernia

Keywords

  • Infected ventral hernia
  • Contaminated incisional hernia
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 9 is below the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Is an adult ≥ 18 years old of either gender
  2. Will undergo a planned open abdominal incisional hernia repair
  3. Has a defect that can be repaired primarily without tension with myofascial advancement flaps and requires no more than 1 piece of surgical mesh (largest mesh size (19 x 35 cm)
  4. Contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction with a bowel resection, or such contaminations occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus
  5. Infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh
  6. Has an estimated hernia size of ≥ 3cm to 20cm in maximal width by physical exam
  7. Is considered a clean-contaminated or contaminated case per Surgical Site Infection Risk Guidelines
  8. Is willing and able to return for all scheduled and required study visits
  9. Is willing and able to provide written informed consent for study participation

Exclusion criteria

Exclusion Criteria:

  1. Has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh
  2. Is a clean or dirty case per Surgical Site Infection Risk Guidelines
  3. Has conditions that would adversely affect subject safety as per product labeling
  4. Will undergo a laparoscopic hernia repair
  5. Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh
  6. Has conditions which preclude abdominal imaging at a standard imaging facility
  7. Has an anticipated survival of \< 24 months
  8. Care plan is to perform a staged repair over 45 days
  9. Is bedridden or otherwise non-ambulatory (i.e. is unable to independently transfer into and out of a wheelchair)
  10. Is ASA class 4 or 5
  11. BMI over 45
  12. Is pregnant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    XenMATRIX

    Use of XenMATRIX mesh to repair hernia

    Device: XenMATRIX mesh · Procedure: Open abdominal ventral hernia repair

Interventions

  • DeviceXenMATRIX mesh

    Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair

    Also known as: Davol Biologic mesh

  • ProcedureOpen abdominal ventral hernia repair

    Abdominal ventral hernia repair with native tissue

    Also known as: Abdominal ventral hernia repair with native tissue

06

What researchers measure

Primary outcomes

  1. The Incidence of Postoperative Hernia Recurrence

    Time frame: two years after surgery date

Secondary outcomes

  1. Compare the Short-term Clinical Outcomes of Postoperative Wound Events

    Time frame: two years after surgery date

  2. Length of Hospital Stay

    Participants will be followed for the duration of the hospital stay, an expected average of 1 week

    Time frame: Number of days up to 1 week

  3. Length of Resource Utilization

    Time frame: two years after surgery date

  4. Antibiotic Usage and Days

    Time frame: two years after surgery date

  5. Resumption of Activities of Daily Living

    Time frame: two years after surgery date

07

Results

Posted Jan 25, 2023

Participant flow

Participant flow — Overall Study
MilestoneXenMATRIX
Started9
Completed0
Not completed9
Withdrew: Study stopped prematurely9

Outcome measures

PrimaryThe Incidence of Postoperative Hernia Recurrence
Time frame:
two years after surgery date

No measurements were reported for this outcome.

SecondaryCompare the Short-term Clinical Outcomes of Postoperative Wound Events
Time frame:
two years after surgery date

No measurements were reported for this outcome.

SecondaryLength of Hospital Stay

Participants will be followed for the duration of the hospital stay, an expected average of 1 week

Time frame:
Number of days up to 1 week

No measurements were reported for this outcome.

SecondaryLength of Resource Utilization
Time frame:
two years after surgery date

No measurements were reported for this outcome.

SecondaryAntibiotic Usage and Days
Time frame:
two years after surgery date

No measurements were reported for this outcome.

SecondaryResumption of Activities of Daily Living
Time frame:
two years after surgery date

No measurements were reported for this outcome.

Adverse events

Collected over AE data not collected. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
XenMATRIX———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)XenMATRIX
<=18 years0
Between 18 and 65 years0
>=65 years9
Sex: Female, Male
Sex: Female, Male(Participants)XenMATRIX
Female4
Male5
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)XenMATRIX
Hispanic or Latino0
Not Hispanic or Latino9
Unknown or Not Reported0
08

Study locations

1 site
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01295125
Lead sponsor
University Hospitals Cleveland Medical Center
Collaborators
Bard Ltd
Responsible party
Sponsor
First posted
Feb 14, 2011
Start date
Jan 2011
Primary completion
May 2012
Completion
May 2012
Results posted
Jan 25, 2023
Last update
Jan 25, 2023

Study contacts

Michael J. Rosen, MD.
principal investigator · University Hospitals Cleveland Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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