Tissue Reinforcement of Incisional Closure Among High Risk Patients
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/4/2018 |
| Start Date: | September 13, 2017 |
| End Date: | December 2022 |
| Contact: | Mike K Liang, MD |
| Email: | Mike.K.Liang@uth.tmc.edu |
| Phone: | 713-566-5098 |
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.
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.
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).
We found this trial at
1
site
5656 Kelley Street
Houston, Texas 77026
Houston, Texas 77026
Principal Investigator: Mike K Liang, MD
Phone: 713-566-5098
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