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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Seprafilm Group No Seprafilm Group
Hide 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
Arm/Group Title Seprafilm No Seprafilm Total
Hide 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
Hide 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
1.Primary Outcome
Title Adhesion Characteristics
Hide Description

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
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seprafilm No Seprafilm
Hide 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
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seprafilm No Seprafilm
Hide 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
Hide Description Determination of ventral hernia presence during follow-up visits
Time Frame Up to 1 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seprafilm No Seprafilm
Hide 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
Hide Description Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seprafilm No Seprafilm
Hide 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
Hide Description Determination of bowel obstruction during the entire available study follow-up period
Time Frame Up to 1 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seprafilm No Seprafilm
Hide 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
Hide 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

  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
Time Frame Up to 1 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Please see Outcome Measure Description [above] for exact measure(s) utilized, including measurement scale(s).
Arm/Group Title Seprafilm No Seprafilm
Hide 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
Hide Description Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint
Time Frame Up to 1 year follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seprafilm No Seprafilm
Hide 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
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
Hide 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   --/--   --/-- 
Hide 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.
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Stanislaw P. Stawicki, M.D.
Organization: St. Luke's University Health Network
Phone: 484-526-4426
EMail: stanislaw.stawicki@sluhn.org
Layout table for additonal information
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