NCT01594385 (OASIT) is a NA clinical trial of Seprafilm in Open Abdomen, sponsored by Stan Stawicki.

Who is sponsoring NCT01594385?

NCT01594385 is sponsored by Stan Stawicki.

What drugs are being tested in NCT01594385?

Interventions in NCT01594385: Seprafilm.

What condition does NCT01594385 study?

NCT01594385 studies Open Abdomen, Abdominal Adhesions, Trauma, Wounds and Injury.

Is NCT01594385 still recruiting?

NCT01594385 is currently completed. Last updated 17 October 2017.

Are results published for NCT01594385?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-10-17 · How we verify

NCT01594385: OASIT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 17 October 2017

What this trial tests

NA trial testing Seprafilm in Open Abdomen in 30 participants. Completed in 1 December 2013.

Timeline

1 April 2010

Primary endpoint
1 September 2013

1 December 2013

Quick facts

Lead sponsor	Stan Stawicki
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	1 April 2010
Primary completion	1 September 2013
Estimated completion	1 December 2013
Sites	5 locations across United States

Drugs / interventions tested

Seprafilm — full drug profile →

Conditions studied

Open Abdomen — all drugs for Open Abdomen →
Abdominal Adhesions — all drugs for Abdominal Adhesions →
Trauma — all drugs for Trauma →
Wounds and Injury — all drugs for Wounds and Injury →

Sponsor

Stan Stawicki — full company profile →

Who can join

Adults 18 to 89, any sex, with Open Abdomen or Abdominal Adhesions. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Adhesion Characteristics
Time frame: 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 at

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Open Abdomen

Currently open trials in the same condition.

NCT06242925 — Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO) · NA · active not recruiting
NCT06428370 — Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01594385 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stan Stawicki
Last refreshed: 17 October 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01594385.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing