Trial Outcomes & Findings for Damage Control Laparotomy (NCT NCT02706041)
NCT ID: NCT02706041
Last Updated: 2021-11-18
Results Overview
Major abdominal complication (MAC) is defined as development of an organ/space surgical site infection, enteric suture line failure, fascial dehiscence, or unplanned return to operating room (OR).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
30 days
Results posted on
2021-11-18
Participant Flow
Participant milestones
| Measure |
Damage Control Laparotomy
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
21
|
|
Overall Study
Received Allocated Intervention
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Damage Control Laparotomy
Baseline characteristics by cohort
| Measure |
Damage Control Laparotomy
n=18 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=21 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
29 years
n=7 Participants
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Mechanism of Injury
Blunt
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Mechanism of Injury
Penetrating
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Area of Injury
Liver
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Area of Injury
Spleen
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Area of Injury
Kidney
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Area of Injury
Small Bowel
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Area of Injury
Large Bowel
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Area of Injury
Pancreas
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Area of Injury
Stomach
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Area of Injury
Major Venous Injury
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Area of Injury
Major Arterial Injury
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Area of Injury
Femur
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Area of Injury
Pelvis
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Area of Injury
Traumatic Brain Injury
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Grade of Liver Injury
|
3 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
3 units on a scale
n=5 Participants
|
|
Grade of Spleen Injury
|
3 units on a scale
n=5 Participants
|
4 units on a scale
n=7 Participants
|
3 units on a scale
n=5 Participants
|
|
Grade of Kidney Injury
|
2 units on a scale
n=5 Participants
|
4 units on a scale
n=7 Participants
|
4 units on a scale
n=5 Participants
|
|
Score on Abbreviated Injury Scale (AIS) - Head
|
0 score on a scale
n=5 Participants
|
1 score on a scale
n=7 Participants
|
0 score on a scale
n=5 Participants
|
|
Score on Abbreviated Injury Scale (AIS) - Chest
|
3 score on a scale
n=5 Participants
|
3 score on a scale
n=7 Participants
|
3 score on a scale
n=5 Participants
|
|
Score on Abbreviated Injury Scale (AIS) - Abdomen
|
4 score on a scale
n=5 Participants
|
3 score on a scale
n=7 Participants
|
3 score on a scale
n=5 Participants
|
|
Injury Severity Score (ISS)
|
29 score on a scale
n=5 Participants
|
34 score on a scale
n=7 Participants
|
33 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.
Major abdominal complication (MAC) is defined as development of an organ/space surgical site infection, enteric suture line failure, fascial dehiscence, or unplanned return to operating room (OR).
Outcome measures
| Measure |
Damage Control Laparotomy
n=18 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=21 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Number of Participants Who Died or Had Major Abdominal Complication (MAC)
Death or Major abdominal complication (MAC)
|
6 Participants
|
12 Participants
|
|
Number of Participants Who Died or Had Major Abdominal Complication (MAC)
Major abdominal complication (MAC)
|
6 Participants
|
8 Participants
|
|
Number of Participants Who Died or Had Major Abdominal Complication (MAC)
Death
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.
Non-abdominal Morbidities include Acute Kidney Failure, Deep Vein Thrombosis, Pulmonary Embolism, Pneumonia, and Urinary Tract Infection.
Outcome measures
| Measure |
Damage Control Laparotomy
n=18 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=21 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Number of Participants With Non-abdominal Morbidities
Number of Participants with Deep Vein Thrombosis
|
0 Participants
|
2 Participants
|
|
Number of Participants With Non-abdominal Morbidities
Number of Participants with Pulmonary Embolism
|
1 Participants
|
1 Participants
|
|
Number of Participants With Non-abdominal Morbidities
Number of Participants with Acute Kidney Failure
|
3 Participants
|
7 Participants
|
|
Number of Participants With Non-abdominal Morbidities
Number of Participants with Pneumonia
|
6 Participants
|
8 Participants
|
|
Number of Participants With Non-abdominal Morbidities
Number of Participants with Urinary Tract Infection
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.
Number of days patient was not in hospital within the 30 day time frame.
Outcome measures
| Measure |
Damage Control Laparotomy
n=18 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=21 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Number of Hospital-free Days
|
13 days
Interval 0.0 to 19.0
|
0 days
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.
Number of days patient not in the ICU during the 30 day time frame
Outcome measures
| Measure |
Damage Control Laparotomy
n=18 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=21 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Number of ICU-free Days
|
24 days
Interval 0.0 to 25.0
|
12 days
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.
Number of days patient not on ventilator in the 30 day time frame
Outcome measures
| Measure |
Damage Control Laparotomy
n=18 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=21 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Number of Ventilator-free Days
|
27 days
Interval 3.0 to 28.0
|
22 days
Interval 0.0 to 27.0
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at discharge from hospital (about 20 days after intervention)Population: These data were not collected from 6 in the Damage control laparotomy arm and 10 in the Definitive closure laparotomy arm.
Participants are asked to choose between two hypothetical outcomes: 1 - the sure outcome, that is, remaining in a state of ill health for a period of time; or 2 - the gamble, that is, choosing a medical intervention which has a certain probability of either restoring them to perfect health or killing them. The Standard Gamble identifies the probability (of the intervention delivering perfect health) at which the two alternatives (1 and 2) seem equally attractive. Scores range from 0% to 100%, with a score of 100% indicating that a choices 1 and 2 are equally attractive only when there is a 100% probability that the intervention will deliver perfect health, and a score of 0% indicating that choices 1 and and 2 are equally attractive even when there is a 0% probability that the intervention will deliver perfect health.
Outcome measures
| Measure |
Damage Control Laparotomy
n=12 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=11 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Patient-centered Outcomes Assessed Using the Standard Gamble
|
2.2 score on a scale
Standard Deviation 5.0
|
0.4 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 6 months after discharge from hospitalPopulation: These data were not collected from 6 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm.
Participants are asked to choose between two hypothetical outcomes: 1 - the sure outcome, that is, remaining in a state of ill health for a period of time; or 2 - the gamble, that is, choosing a medical intervention which has a certain probability of either restoring them to perfect health or killing them. The Standard Gamble identifies the probability (of the intervention delivering perfect health) at which the two alternatives (1 and 2) seem equally attractive. Scores range from 0% to 100%, with a score of 100% indicating that a choices 1 and 2 are equally attractive only when there is a 100% probability that the intervention will deliver perfect health, and a score of 0% indicating that choices 1 and and 2 are equally attractive even when there is a 0% probability that the intervention will deliver perfect health.
Outcome measures
| Measure |
Damage Control Laparotomy
n=12 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=12 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Patient-centered Outcomes Assessed Using the Standard Gamble
|
9.5 score on a scale
Standard Deviation 16.8
|
1.7 score on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: at discharge from hospital (about 20 days after intervention)Population: These data were not collected from 2 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm.
The EuroQol-5D-5L assesses health-related quality of life. Total score ranges from 0 to 100, with 0 indicating the worst health imaginable and 100 indicating the best health imaginable.
Outcome measures
| Measure |
Damage Control Laparotomy
n=16 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=12 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L)
|
19 score on a scale
Standard Deviation 33
|
25 score on a scale
Standard Deviation 33
|
SECONDARY outcome
Timeframe: 6 months after discharge from hospitalPopulation: These data were not collected from 5 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm.
The EuroQol-5D-5L assesses health-related quality of life. Total score ranges from 0 to 100, with 0 indicating the worst health imaginable and 100 indicating the best health imaginable.
Outcome measures
| Measure |
Damage Control Laparotomy
n=13 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=12 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L)
|
55 score on a scale
Standard Deviation 36
|
49 score on a scale
Standard Deviation 40
|
SECONDARY outcome
Timeframe: at discharge from hospital (about 20 days after intervention)Population: These data were not collected from 5 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm.
The PCL-C assesses Post-Traumatic Stress Disorder (PTSD) symptoms. Total score ranges from 17-85. A score of 17-29 shows little to no PTSD symptoms. A score of 28-29 indicates some PTSD symptoms. A score of 30-44 indicates moderate to moderately high severity of PTSD symptoms. A score of 45-85 indicates high severity of PTSD symptoms.
Outcome measures
| Measure |
Damage Control Laparotomy
n=13 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=12 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C)
|
35 score on a scale
Standard Deviation 14
|
32 score on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 6 months after discharge from hospitalPopulation: These data were not collected from 7 in the Damage control laparotomy arm and 8 in the Definitive closure laparotomy arm.
The PCL-C assesses Post-Traumatic Stress Disorder (PTSD) symptoms. Total score ranges from 17-85. A score of 17-29 shows little to no PTSD symptoms. A score of 28-29 indicates some PTSD symptoms. A score of 30-44 indicates moderate to moderately high severity of PTSD symptoms. A score of 45-85 indicates high severity of PTSD symptoms.
Outcome measures
| Measure |
Damage Control Laparotomy
n=11 Participants
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=13 Participants
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C)
|
39 score on a scale
Standard Deviation 16
|
31 score on a scale
Standard Deviation 11
|
Adverse Events
Damage Control Laparotomy
Serious events: 11 serious events
Other events: 6 other events
Deaths: 0 deaths
Definitive Closure Laparotomy
Serious events: 16 serious events
Other events: 7 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Damage Control Laparotomy
n=18 participants at risk
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=21 participants at risk
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/18 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
33.3%
7/21 • Number of events 7 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
|
Infections and infestations
Organ/space surgical site infection
|
27.8%
5/18 • Number of events 5 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
38.1%
8/21 • Number of events 8 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
|
Musculoskeletal and connective tissue disorders
Fascial dehiscence
|
0.00%
0/18 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
19.0%
4/21 • Number of events 4 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
|
Surgical and medical procedures
Reopening after closure
|
11.1%
2/18 • Number of events 2 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
28.6%
6/21 • Number of events 6 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
|
Immune system disorders
Sepsis
|
50.0%
9/18 • Number of events 9 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
52.4%
11/21 • Number of events 11 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
|
Renal and urinary disorders
Acute renal failure
|
16.7%
3/18 • Number of events 3 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
33.3%
7/21 • Number of events 7 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
|
General disorders
Multi-organ failure
|
22.2%
4/18 • Number of events 4 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
28.6%
6/21 • Number of events 6 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
Other adverse events
| Measure |
Damage Control Laparotomy
n=18 participants at risk
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Damage Control Laparotomy: Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
|
Definitive Closure Laparotomy
n=21 participants at risk
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
|
|---|---|---|
|
Gastrointestinal disorders
Ileus
|
33.3%
6/18 • Number of events 6 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
33.3%
7/21 • Number of events 7 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
|
Vascular disorders
Pulmonary embolus
|
5.6%
1/18 • Number of events 1 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
4.8%
1/21 • Number of events 1 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/18 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
9.5%
2/21 • Number of events 2 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
|
Infections and infestations
Superficial surgical site infection
|
5.6%
1/18 • Number of events 1 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
19.0%
4/21 • Number of events 4 • From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
|
Additional Information
John A. Harvin, MD, FACS, Associate Professor
The University of Texas Health Science Center at Houston
Phone: (713) 500-7244
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place