An Analysis of Cytokine Concentration in Open Abdominal Closure of Trauma Patients

NCT02728609 | Completed

• 1 other identifier: 10-00739-FB
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the pro-inflammatory and anti-inflammatory cytokines, protein content, and white blood cell (WBC) count present in the peritoneal fluid and plasma of trauma patients who undergo one of two different methods of open abdominal closure. Following analysis of the peritoneal fluid and serum samples, comparison of the results between the two groups will be completed and correlated with the overall organ function.

Conditions

Abdominal Trauma

Outcome Measures

Primary Outcomes (1)

• Change in cytokine levels over 72 hours in peritoneal fluid in each enrolled subject

  Fluid will be obtained from the collection portion of the device into a Lukens trap. Fluid will be centrifuged into separate specimens and frozen at -80 degrees centigrade prior to analysis. Specimens will be analyzed using standard laboratory process.

  Change in cytokine levels over 72 hours following placement of the device

Secondary Outcomes (3)

• Change in white blood cell count in peritoneal fluid over 72 hours following placement of the device in each enrolled subject

  Serial samples obtained over 72 hours following placement of the device

• Change in protein content in peritoneal fluid over 72 hours following placement of the device in each enrolled subject

  Serial samples obtained over 72 hours following placement of the device

• Change in cytokine levels in serum samples over 72 hours following placement of the device in each enrolled subject

  Serial samples obtained over 72 hours following placement of the device

Study Arms (2)

Blue towel: vacuum pack device

Trauma subjects undergoing temporary abdominal closure with vacuum pack technique

Device: Blue towel: vacuum pack device

ABThera abdominal closure

Trauma subjects undergoing temporary abdominal closure with the commercially available ABThera vacuum device

Device: ABThera vacuum device

Interventions

ABThera vacuum device DEVICE

This intervention uses a commercially available vacuum device to temporarily close the abdomen following surgery.

Also known as: Commercially available vacuum pack closure

ABThera abdominal closure

Blue towel: vacuum pack device DEVICE

This intervention uses operating room towels and the application of suction to temporarily close the abdomen following surgery.

Blue towel: vacuum pack device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the Presley Memorial Trauma Center undergoing open abdominal closure with a vacuum device will be invited to participate. A total of 40 patients with 20 patients in each group will be included.

You may qualify if:

• to 75 years of age who have been admitted following abdominal trauma and require open laparotomy
• Those who are closed using either the blue towel: vacuum pack method or the ABThera vacuum device
• Those who can be enrolled within 12 hours of placement of temporary abdominal closure

You may not qualify if:

• Those who cannot give informed consent and do not have a Legally Authorized Representative available
• Prisoners are excluded
• Pregnant women are excluded
• Those under 18 years of age and older than 75 years of age
• Those who do not require temporary abdominal closure using either the blue towel: vacuum pack technique or with the ABThera vacuum device.

Sponsors & Collaborators

• University of Tennessee: lead
• Kinetic Concepts, Inc.: collaborator

Related Publications (3)

• Spindler-Vesel A, Wraber B, Vovk I, Kompan L. Intestinal permeability and cytokine inflammatory response in multiply injured patients. J Interferon Cytokine Res. 2006 Oct;26(10):771-6. doi: 10.1089/jir.2006.26.771.

  PMID: 17032171 BACKGROUND

• Kowal-Vern A, Ortegel J, Bourdon P, Chakrin A, Latenser BA, Kimball D, Casey LC. Elevated cytokine levels in peritoneal fluid from burned patients with intra-abdominal hypertension and abdominal compartment syndrome. Burns. 2006 Aug;32(5):563-9. doi: 10.1016/j.burns.2005.12.010.

  PMID: 16766124 BACKGROUND

• Liener UC, Bruckner UB, Knoferl MW, Steinbach G, Kinzl L, Gebhard F. Chemokine activation within 24 hours after blunt accident trauma. Shock. 2002 Mar;17(3):169-72. doi: 10.1097/00024382-200203000-00002.

  PMID: 11900333 BACKGROUND

Biospecimen

Retention: NONE RETAINED

peritoneal fluid and blood samples

MeSH Terms

Conditions

Abdominal Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Timothy C. Fabian, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Harwell Wilson Alumni Professor

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 5, 2016
• Study Start: March 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 5, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share