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

NCT01594385 | Completed Results DMC

• 1 other identifier: 2009H0311
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:

• the number and intensity of adhesions,
• whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,
• rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and
• whether there is any difference between treatment groups regarding patient functional recovery.

Conditions

Open Abdomen; Abdominal Adhesions; Trauma; Wounds and Injury

Keywords

Open Abdomen; Damage Control; Trauma; Wound healing; Gun shot wounds; Stab wounds; Automobile accidents; Wounds and Injury

Outcome Measures

Primary Outcomes (1)

• Adhesion Characteristics

  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

  Up to 1 year

Secondary Outcomes (1)

• Wound Healing Characteristics

  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.

Other Outcomes (7)

• Patient Mortality

  28 days & end of follow-up

• Enterocutaneous and Other Fistula

  Up to 1 year post-injury

• Ventral Hernia

  Up to 1 year follow-up

Study Arms (2)

Seprafilm

OTHER

The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in 1:1 ratio.

Biological: Seprafilm

No Seprafilm

NO INTERVENTION

This group will be treated according to the current standard of care. No seprafilm will be applied in this subset of patients.

Interventions

Seprafilm BIOLOGICAL

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.

Seprafilm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trauma patients undergoing DC/OA management for traumatic injury
• Age 18+
• Life expectancy longer than 48 hours

You may not qualify if:

• Prisoners
• Pregnant patients
• Younger than 18 years of age

Sponsors & Collaborators

• Stan Stawicki: lead

Study Sites (5)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 32861, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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.

  PMID: 24962185 RESULT

MeSH Terms

Conditions

Wounds and Injuries; Wounds, Stab

Interventions

Seprafilm

Condition Hierarchy (Ancestors)

Wounds, Penetrating

Results Point of Contact

• Title: Stanislaw P. Stawicki, M.D.
• Organization: St. Luke's University Health Network

stanislaw.stawicki@sluhn.org

484-526-4426

Study Officials

• Stanislaw P Stawicki, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: May 9, 2012
• Study Start: April 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 20, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)