Trial Outcomes & Findings for Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients (NCT NCT01594385)

Results Overview

Zuhlke adhesion score (1 - minimum to 4 - maximum) 1. = filmy adhesions, easy to separate by blunt dissection 2. = stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization 3. = strong adhesions; lysis possible by sharp dissection only; clear vascularization 4. = very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2017-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Seprafilm Group Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.	No Seprafilm Group Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
Overall Study STARTED	17	13
Overall Study COMPLETED	17	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Seprafilm n=17 Participants The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in approximately 1:1 ratio. Seprafilm: Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas: * Two Seprafilm pieces between the liver and the anterior abdominal wall * Four pieces over the exposed bowel surfaces anteriorly * Two slightly staggered pieces of Seprafilm in each colic gutter * Two pieces in the pelvic area. * If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair.	No Seprafilm n=13 Participants Patients in this group will not receive Seprafilm during re-operations. Otherwise, their surgical management will be identical to the Seprafilm Group.	Total n=30 Participants Total of all reporting groups
Age, Continuous	40.4 years STANDARD_DEVIATION 16.7 • n=5 Participants	40.2 years STANDARD_DEVIATION 16.3 • n=7 Participants	40.3 years STANDARD_DEVIATION 16.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	13 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Zuhlke adhesion score (1 - minimum to 4 - maximum) 1. = filmy adhesions, easy to separate by blunt dissection 2. = stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization 3. = strong adhesions; lysis possible by sharp dissection only; clear vascularization 4. = very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable

Outcome measures

Outcome measures
Measure	Seprafilm n=62 Zuhlke Adhesion Score Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25	No Seprafilm n=58 Zuhlke Adhesion Score Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
Adhesion Characteristics Operation 1	1.06 Scores on a scale Standard Error 0.24	1.08 Scores on a scale Standard Error 0.28
Adhesion Characteristics Operation 4	1.39 Scores on a scale Standard Error 0.49	1.63 Scores on a scale Standard Error 0.58
Adhesion Characteristics Operation 5	1.21 Scores on a scale Standard Error 0.39	2.33 Scores on a scale Standard Error 0.82
Adhesion Characteristics Operation 6	1.50 Scores on a scale Standard Error 0.77	2.92 Scores on a scale Standard Error 0.83
Adhesion Characteristics Operation 7+	1.38 Scores on a scale Standard Error 0.25	2.84 Scores on a scale Standard Error 0.23
Adhesion Characteristics Operation 2	1.13 Scores on a scale Standard Error 0.34	1.08 Scores on a scale Standard Error 0.28
Adhesion Characteristics Operation 3	1.54 Scores on a scale Standard Error 0.69	1.19 Scores on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: Participants will be followed until their open abdomen is closed. Depending on the nature and severity of the wound, this period may last as long as 1 year after the patient has been discharged.

Population: Wound areas for Seprafilm and "No Seprafilm" groups were obtained serially, by measuring each wound horizontally and vertically and multiplying measurements (in centimeters) to determine the estimated area in cm squared.

There will not be a fixed duration of outpatient follow-up (fixed follow-up in trauma patients is not practical due to the unpredictable nature of trauma population), an average (mean) follow-up will be determined for the entire cohort of patients for the purposes of the study, up to a maximum of 1 year (if available) following hospital discharge.

Outcome measures

Outcome measures
Measure	Seprafilm n=17 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25	No Seprafilm n=13 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
Wound Healing Characteristics Composite wound size (cm2): Time 0	419 Square Centimeters (cm2) Standard Deviation 238	393 Square Centimeters (cm2) Standard Deviation 225
Wound Healing Characteristics Composite wound size (cm2): Week 02	282 Square Centimeters (cm2) Standard Deviation 224	322 Square Centimeters (cm2) Standard Deviation 231
Wound Healing Characteristics Composite wound size (cm2): Week 04	223 Square Centimeters (cm2) Standard Deviation 278	218 Square Centimeters (cm2) Standard Deviation 199
Wound Healing Characteristics Composite wound size (cm2): Week 08	76 Square Centimeters (cm2) Standard Deviation 70	210 Square Centimeters (cm2) Standard Deviation 176
Wound Healing Characteristics Composite wound size (cm2): Week 12	35 Square Centimeters (cm2) Standard Deviation 5	116 Square Centimeters (cm2) Standard Deviation 28
Wound Healing Characteristics Composite wound size (cm2): Week 24	66 Square Centimeters (cm2) Standard Deviation 30	148 Square Centimeters (cm2) Standard Deviation 106
Wound Healing Characteristics Composite wound size (cm2): Week 32	64 Square Centimeters (cm2) Standard Deviation 55	59 Square Centimeters (cm2) Standard Deviation 36

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days & end of follow-up

Population: Note: Both mortalities in the Seprafilm group involved withdrawal of care as per previously stated patient wishes.

Assessment of patient mortality at 28 days, with subsequent determination of survival (i.e., patient status at last known follow-up)

Outcome measures

Outcome measures
Measure	Seprafilm n=17 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25	No Seprafilm n=13 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
Patient Mortality	2 Mortalities	1 Mortalities

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 year post-injury

Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval

Outcome measures

Outcome measures
Measure	Seprafilm n=17 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25	No Seprafilm n=13 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
Enterocutaneous and Other Fistula	3 Total events	6 Total events

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 year follow-up

Determination of ventral hernia presence during follow-up visits

Outcome measures

Outcome measures
Measure	Seprafilm n=17 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25	No Seprafilm n=13 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
Ventral Hernia	1 Hernia	0 Hernia

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 year

Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods

Outcome measures

Outcome measures
Measure	Seprafilm n=17 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25	No Seprafilm n=13 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
Infection / Abscess / Sepsis	4 Total events	3 Total events

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 year follow-up

Determination of bowel obstruction during the entire available study follow-up period

Outcome measures

Outcome measures
Measure	Seprafilm n=17 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25	No Seprafilm n=13 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
Bowel Obstruction	0 Bowel obstruction	1 Bowel obstruction

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 year follow-up

Population: Please see Outcome Measure Description \[above\] for exact measure(s) utilized, including measurement scale(s).

Assessment of Glasgow Outcome Scale (GOS) and the Functional Outcome Measures (FOM) during the available follow-up period. FOM Source: \[1\] Ohio Dept of Public Safety. Ohio Trauma Registry Data Dictionary. Columbus: 2004. FOM Scale range: 1 (worst) to 4 (best); GOS Scale: 1 (worst) to 5 (best) FOM Feeding Subscale 1. Fully dependent 2. Partially dependent 3. Independent w/device 4. Fully independent FOM Locomotion Subscale 1. Fully dependent 2. Partially dependent 3. Independent w/device 4. Fully independent FOM Expression/Communication Subscale 1. Fully dependent 2. Partially dependent 3. Independent w/device 4. Fully independent Glasgow Outcome Scale: 1. Death 2. Persistent vegetative state: Minimal responsiveness 3. Severe disability: Conscious but disabled; dependent on others for daily support 4. Moderate disability: Disabled but independent; can work in sheltered setting 5. Good recovery: Resumption of normal life despite minor deficits

Outcome measures

Outcome measures
Measure	Seprafilm n=17 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25	No Seprafilm n=13 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
Patient Functional Outcomes Self-Feeding Score	2.93 units on a scale Standard Deviation 1.44	3.25 units on a scale Standard Deviation 1.14
Patient Functional Outcomes Locomotion Score	2.6 units on a scale Standard Deviation 1.24	2.25 units on a scale Standard Deviation 0.87
Patient Functional Outcomes Expression / Communication	3.47 units on a scale Standard Deviation 1.13	3.45 units on a scale Standard Deviation 1.21
Patient Functional Outcomes Glasgow Outcome Score	4.07 units on a scale Standard Deviation 0.80	3.40 units on a scale Standard Deviation 0.97

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 year follow-up period

Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint

Outcome measures

Outcome measures
Measure	Seprafilm n=17 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25	No Seprafilm n=13 Participants Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
Would Complication	5 Wound complication	3 Wound complication

Adverse Events

Seprafilm Group

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

No Seprafilm Group

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Seprafilm Group n=17 participants at risk Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.	No Seprafilm Group n=13 participants at risk Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
Surgical and medical procedures Mortality	11.8% 2/17 • Daily assessments for adverse events (AE) were performed during the initial hospitalization phase for each patient; Additional AE screening was done during outpatient visits; AE data were collected during up to 1 year voluntary follow-up.	7.7% 1/13 • Daily assessments for adverse events (AE) were performed during the initial hospitalization phase for each patient; Additional AE screening was done during outpatient visits; AE data were collected during up to 1 year voluntary follow-up.

Other adverse events

Other adverse events
Measure	Seprafilm Group n=17 participants at risk Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.	No Seprafilm Group n=13 participants at risk Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
Respiratory, thoracic and mediastinal disorders Respiratory failure	29.4% 5/17 • Daily assessments for adverse events (AE) were performed during the initial hospitalization phase for each patient; Additional AE screening was done during outpatient visits; AE data were collected during up to 1 year voluntary follow-up.	38.5% 5/13 • Daily assessments for adverse events (AE) were performed during the initial hospitalization phase for each patient; Additional AE screening was done during outpatient visits; AE data were collected during up to 1 year voluntary follow-up.

Additional Information

Stanislaw P. Stawicki, M.D.

St. Luke's University Health Network

Phone: 484-526-4426

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place