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

• ClinicalTrials.gov Identifier: NCT01594385
• Recruitment Status: Completed
• First Posted: May 9, 2012
• Results First Posted: May 30, 2017
• Last Update Posted: November 20, 2017
• Sponsor: Stan Stawicki
• Information provided by (Responsible Party): Stan Stawicki, St. Luke's Hospital and Health Network, Pennsylvania

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Conditions: Open Abdomen; Abdominal Adhesions; Trauma; Wounds and Injury
• Intervention: Biological: Seprafilm
• Enrollment: 30

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Seprafilm Group	No Seprafilm Group
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	17	13
Completed	17	13
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Seprafilm	No Seprafilm	Total
Arm/Group Description		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.	Patients in this group will not receive Seprafilm during re-operations. Otherwise, their surgical management will be identical to the Seprafilm Group.	Total of all reporting groups
Overall Number of Baseline Participants		17	13	30
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	17 participants	13 participants	30 participants
		40.4 (16.7)	40.2 (16.3)	40.3 (16.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants	13 participants	30 participants
	Female	4 23.5%	3 23.1%	7 23.3%
	Male	13 76.5%	10 76.9%	23 76.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	17 participants	13 participants	30 participants
		17	13	30

Outcome Measures

1. Primary Outcome

Title	Adhesion Characteristics
Description	Zuhlke adhesion score (1 - minimum to 4 - maximum); = filmy adhesions, easy to separate by blunt dissection; = stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization; = strong adhesions; lysis possible by sharp dissection only; clear vascularization; = very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seprafilm	No Seprafilm
Arm/Group Description:	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	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
Overall Number of Participants Analyzed	17	13
Overall Number of Units Analyzed; Type of Units Analyzed: Zuhlke Adhesion Score	62	58
Mean (Standard Error); Unit of Measure: Scores on a scale
Operation 1	1.06 (0.24)	1.08 (0.28)
Operation 2	1.13 (0.34)	1.08 (0.28)
Operation 3	1.54 (0.69)	1.19 (0.32)
Operation 4	1.39 (0.49)	1.63 (0.58)
Operation 5	1.21 (0.39)	2.33 (0.82)
Operation 6	1.50 (0.77)	2.92 (0.83)
Operation 7+	1.38 (0.25)	2.84 (0.23)

2. Secondary Outcome

Title	Wound Healing Characteristics
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Wound Sizes: Seprafilm	Wound Sizes: No Seprafilm
Arm/Group Description:	Wound size characteristics (estimated area = "Width x Length" in centimeters squared) for patients who received Seprafilm	Wound size characteristics (estimated area = "Width x Length" in centimeters squared) for patients who did not receive Seprafilm
Overall Number of Participants Analyzed	17	13
Mean (Standard Deviation); Unit of Measure: Square Centimeters (cm2)
Composite wound size (cm2): Time 0	419 (238)	393 (225)
Composite wound size (cm2): Week 02	282 (224)	322 (231)
Composite wound size (cm2): Week 04	223 (278)	218 (199)
Composite wound size (cm2): Week 08	76 (70)	210 (176)
Composite wound size (cm2): Week 12	35 (5)	116 (28)
Composite wound size (cm2): Week 24	66 (30)	148 (106)
Composite wound size (cm2): Week 32	64 (55)	59 (36)

3. Other Pre-specified Outcome

Title	Patient Mortality
Description	Assessment of patient mortality at 28 days, with subsequent determination of survival (i.e., patient status at last known follow-up)
Time Frame	28 days & end of follow-up

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Seprafilm	No Seprafilm
Arm/Group Description:	The treatment group will receive Seprafilm.	This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
Overall Number of Participants Analyzed	17	13
Measure Type: Number; Unit of Measure: Mortalities
	2	1

4. Other Pre-specified Outcome

Title	Enterocutaneous and Other Fistula
Description	Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval
Time Frame	Up to 1 year post-injury

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seprafilm	No Seprafilm
Arm/Group Description:	The treatment group will receive Seprafilm.	This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
Overall Number of Participants Analyzed	17	13
Measure Type: Number; Unit of Measure: Total events
	3	6

5. Other Pre-specified Outcome

Title	Ventral Hernia
Description	Determination of ventral hernia presence during follow-up visits
Time Frame	Up to 1 year follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seprafilm	No Seprafilm
Arm/Group Description:	The treatment group will receive Seprafilm.	This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
Overall Number of Participants Analyzed	17	13
Measure Type: Number; Unit of Measure: Hernia
	1	0

6. Other Pre-specified Outcome

Title	Infection / Abscess / Sepsis
Description	Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seprafilm	No Seprafilm
Arm/Group Description:	The treatment group will receive Seprafilm.	This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
Overall Number of Participants Analyzed	17	13
Measure Type: Number; Unit of Measure: Total events
	4	3

7. Other Pre-specified Outcome

Title	Bowel Obstruction
Description	Determination of bowel obstruction during the entire available study follow-up period
Time Frame	Up to 1 year follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seprafilm	No Seprafilm
Arm/Group Description:	The treatment group will receive Seprafilm.	This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
Overall Number of Participants Analyzed	17	13
Measure Type: Number; Unit of Measure: Bowel obstruction
	0	1

8. Other Pre-specified Outcome

Title	Patient Functional Outcomes
Description	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; Fully dependent; Partially dependent; Independent w/device; Fully independent FOM Locomotion Subscale; Fully dependent; Partially dependent; Independent w/device; Fully independent FOM Expression/Communication Subscale; Fully dependent; Partially dependent; Independent w/device; Fully independent Glasgow Outcome Scale: Death; Persistent vegetative state: Minimal responsiveness; Severe disability: Conscious but disabled; dependent on others for daily support; Moderate disability: Disabled but independent; can work in sheltered setting; Good recovery: Resumption of normal life despite minor deficits
Time Frame	Up to 1 year follow-up

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Seprafilm	No Seprafilm
Arm/Group Description:	The treatment group will receive Seprafilm.	This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
Overall Number of Participants Analyzed	17	13
Mean (Standard Deviation); Unit of Measure: units on a scale
Self-Feeding Score	2.93 (1.44)	3.25 (1.14)
Locomotion Score	2.6 (1.24)	2.25 (0.87)
Expression / Communication	3.47 (1.13)	3.45 (1.21)
Glasgow Outcome Score	4.07 (0.80)	3.40 (0.97)

9. Other Pre-specified Outcome

Title	Would Complication
Description	Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint
Time Frame	Up to 1 year follow-up period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seprafilm	No Seprafilm
Arm/Group Description:	The treatment group will receive Seprafilm.	This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.
Overall Number of Participants Analyzed	17	13
Measure Type: Number; Unit of Measure: Wound complication
	5	3

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Seprafilm Group	No Seprafilm Group
Arm/Group Description	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.	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.
All-Cause Mortality
	Seprafilm Group	No Seprafilm Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Seprafilm Group	No Seprafilm Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/17 (11.76%)	1/13 (7.69%)
Surgical and medical procedures
Mortality † [1]	2/17 (11.76%)	1/13 (7.69%)
† Indicates events were collected by systematic assessment; [1] Two patients (2/17) in the Seprafilm group experienced 28-day mortality; One patient (1/13) in No Seprafilm group experienced 28-day mortality; Mortality was attributed to high injury severity and physiologic acuity; Not associated with the study.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Seprafilm Group	No Seprafilm Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	5/17 (29.41%)	5/13 (38.46%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure † [1]	5/17 (29.41%)	5/13 (38.46%)
† Indicates events were collected by systematic assessment; [1] 5/17 patients in Seprafilm group developed respiratory failure; 5/13 in No Seprafilm group developed respiratory failure; All instances of respiratory failure were related to injury severity / physiologic acuity; Not related to study conduct

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Stanislaw P. Stawicki, M.D.
• Organization: St. Luke's University Health Network
• Phone: 484-526-4426
• EMail: stanislaw.stawicki@sluhn.org

Publications of Results:

Stawicki SP, Green JM, Martin ND, Green RH, Cipolla J, Seamon MJ, Eiferman DS, Evans DC, Hazelton JP, Cook CH, Steinberg SM; OPUS 12 Foundation, Inc, Multi-Center Trials Group & OASIT Investigators. Results of a prospective, randomized, controlled study of the use of carboxymethylcellulose sodium hyaluronate adhesion barrier in trauma open abdomens. Surgery. 2014 Aug;156(2):419-30. doi: 10.1016/j.surg.2014.03.007. Epub 2014 Mar 15.

• Responsible Party: Stan Stawicki, St. Luke's Hospital and Health Network, Pennsylvania
• ClinicalTrials.gov Identifier: NCT01594385
• Other Study ID Numbers: 2009H0311
• First Submitted: January 5, 2012
• First Posted: May 9, 2012
• Results First Submitted: May 10, 2014
• Results First Posted: May 30, 2017
• Last Update Posted: November 20, 2017