Wound Complication
Conditions
Keywords
abdominal surgery, wound complication
Brief 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.
Interventions
DEVICEBiologic Mesh
Biologic mesh placed during surgery
PROCEDURESmall Bites
0.5 cm x 0.5 cm sutures used
PROCEDURELarge Bites
1.0 x 1.0 sutures used
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Major Chronic Wound Infection | 1 year after surgery | Proportion of participants with major chronic wound infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Infections | 1 year after surgery | — |
| Number of Participants With Reoperations | 1 year after surgery | any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity |
| Operative Duration | about 119 minutes to 337 minutes | length of the entire procedure |
| Number of Participants With Major Complications | 1 year after surgery | Major complications include surgical site infection, ventral incisional hernia, and/or reoperation |
| Participants Health Status as Assessed by the Euroqol-5D Questionnaire | 1 year after surgery | Health Status is scored from 0 to 100, where the higher the score the better the health |
| Cost Analyses | 1 year after surgery | calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures |
| Surgeon Perception | 1 year after surgery | likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial |
| Participants Quality of Life as Assessed by Activities Assessment Scale | 1 year after surgery | Quality of life is scored from 1 to 100, where the higher the score the higher quality of life |
Countries
United States
Participant flow
Pre-assignment details
Of the 163 participants enrolled, 107 met inclusion criteria and were randomized
Participants by arm
| Arm | Count |
|---|---|
| Biologic Mesh and Small Bites Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used | 27 |
| Small Bites and No Biologic Mesh Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used | 28 |
| Biologic Mesh and Large Bites Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used | 25 |
| Large Bites and no Biologic Mesh Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used | 27 |
| Total | 107 |
Baseline characteristics
| Characteristic | Biologic Mesh and Small Bites | Small Bites and No Biologic Mesh | Biologic Mesh and Large Bites | Large Bites and no Biologic Mesh | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 2 Participants | 7 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 26 Participants | 23 Participants | 20 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 23 Participants | 16 Participants | 18 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 5 Participants | 9 Participants | 9 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 27 participants | 28 participants | 25 participants | 27 participants | 107 participants |
| Sex: Female, Male Female | 15 Participants | 11 Participants | 9 Participants | 13 Participants | 48 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 16 Participants | 14 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 28 | 0 / 25 | 0 / 27 |
| other Total, other adverse events | 4 / 27 | 5 / 28 | 5 / 25 | 2 / 27 |
| serious Total, serious adverse events | 2 / 27 | 1 / 28 | 2 / 25 | 2 / 27 |
Outcome results
Primary
Proportion of Participants Major Chronic Wound Infection
Proportion of participants with major chronic wound infection
Time frame: 1 year after surgery
Population: Data were not collected for this outcome measure.
Secondary
Cost Analyses
calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures
Time frame: 1 year after surgery
Population: Data were not collected for this outcome measure.
Secondary
Cost Analyses
calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures
Time frame: 3 years after surgery
Population: Data were not collected for this outcome measure.
Secondary
Number of Participants With Major Complications
Major complications include surgical site infection, ventral incisional hernia, and/or reoperation
Time frame: 3 years after surgery
Population: Data were not collected for this outcome measure.
Secondary
Number of Participants With Major Complications
Major complications include surgical site infection, ventral incisional hernia, and/or reoperation
Time frame: 1 year after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biologic Mesh and Small Bites | Number of Participants With Major Complications | 5 Participants |
| Small Bites and No Biologic Mesh | Number of Participants With Major Complications | 5 Participants |
| Biologic Mesh and Large Bites | Number of Participants With Major Complications | 6 Participants |
| Large Bites and no Biologic Mesh | Number of Participants With Major Complications | 4 Participants |
Secondary
Number of Participants With Reoperations
any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity
Time frame: 1 year after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biologic Mesh and Small Bites | Number of Participants With Reoperations | 2 Participants |
| Small Bites and No Biologic Mesh | Number of Participants With Reoperations | 1 Participants |
| Biologic Mesh and Large Bites | Number of Participants With Reoperations | 2 Participants |
| Large Bites and no Biologic Mesh | Number of Participants With Reoperations | 2 Participants |
Secondary
Number of Participants With Reoperations
any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity
Time frame: 3 years after surgery
Population: Data were not collected for this outcome measure.
Secondary
Number of Participants With Surgical Site Infections
Time frame: 3 years after surgery
Population: Data were not collected for this outcome measure.
Secondary
Number of Participants With Surgical Site Infections
Time frame: 1 year after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biologic Mesh and Small Bites | Number of Participants With Surgical Site Infections | 2 Participants |
| Small Bites and No Biologic Mesh | Number of Participants With Surgical Site Infections | 1 Participants |
| Biologic Mesh and Large Bites | Number of Participants With Surgical Site Infections | 1 Participants |
| Large Bites and no Biologic Mesh | Number of Participants With Surgical Site Infections | 0 Participants |
Secondary
Operative Duration
length of the entire procedure
Time frame: about 119 minutes to 337 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biologic Mesh and Small Bites | Operative Duration | 210.19 minutes | Standard Deviation 70.96 |
| Small Bites and No Biologic Mesh | Operative Duration | 205.50 minutes | Standard Deviation 70.96 |
| Biologic Mesh and Large Bites | Operative Duration | 230.64 minutes | Standard Deviation 106.48 |
| Large Bites and no Biologic Mesh | Operative Duration | 180.26 minutes | Standard Deviation 61.58 |
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
Time frame: 1 year after surgery
Population: Data were not collected for 13 participants in the Biologic Mesh arm. Data were not collected for 10 participants in the No Biologic Mesh arm. Data were not collected for 7 participants in the Large Bites arm. Data were not collected for 16 participants in the Small Bites arm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Biologic Mesh and Small Bites | Participants Health Status as Assessed by the Euroqol-5D Questionnaire | 80 score on a scale |
| Small Bites and No Biologic Mesh | Participants Health Status as Assessed by the Euroqol-5D Questionnaire | 80 score on a scale |
| Biologic Mesh and Large Bites | Participants Health Status as Assessed by the Euroqol-5D Questionnaire | 80 score on a scale |
| Large Bites and no Biologic Mesh | Participants Health Status as Assessed by the Euroqol-5D Questionnaire | 80 score on a scale |
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
Time frame: 3 years after surgery
Population: Data were not collected for this outcome measure.
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
Time frame: 3 years after surgery
Population: Data were not collected for this outcome measure.
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
Time frame: 1 year after surgery
Population: Data were not collected for 13 participants in the Biologic Mesh arm. Data were not collected for 10 participants in the No Biologic Mesh arm. Data were not collected for 7 participants in the Large Bites arm. Data were not collected for 16 participants in the Small Bites arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biologic Mesh and Small Bites | Participants Quality of Life as Assessed by Activities Assessment Scale | 64 score on a scale | Standard Deviation 33 |
| Small Bites and No Biologic Mesh | Participants Quality of Life as Assessed by Activities Assessment Scale | 70 score on a scale | Standard Deviation 31 |
| Biologic Mesh and Large Bites | Participants Quality of Life as Assessed by Activities Assessment Scale | 68 score on a scale | Standard Deviation 32 |
| Large Bites and no Biologic Mesh | Participants Quality of Life as Assessed by Activities Assessment Scale | 66 score on a scale | Standard Deviation 32 |
Secondary
Surgeon Perception
likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial
Time frame: 3 years after surgery
Population: Data were not collected for this outcome measure.
Secondary
Surgeon Perception
likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial
Time frame: 1 year after surgery
Population: Data were not collected for this outcome measure.