Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Ulcer

Adenomatous Polyposis Coli

Colitis

Tissue Adhesions

Colitis, Ulcerative

Gastroenteritis

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Inflammatory Bowel Diseases

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

SprayShield Adhesion Barrier System

Good Surgical Technique Alone

This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.

An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery

An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion in Abdominal Surgery

Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are "1", "2", and "3". Subjects without adhesions were assigned a severity rating of "0".

The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.

The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.

Integra LifeSciences Corporation

SprayShield Adhesion Barrier + Good Surgical Technique

SprayShield Adhesion Barrier

Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Czech Republic

Poland

Region of Enrollment

Early termination leading to small numbers of subjects analyzed

Stefani Battaglia

All 11 patients met the per protocol population requirements specified in the protocol and statistical analysis plan.

The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.

All 11 subjects met the definition of per protocol population in the protocol and statistical analysis plan.

Severity of Adhesions

These patients must have values for length of the incision associated with adhesions (cm) and for length of initial midline incision (cm) in order to calculate Extent of Adhesion Involvement (%). NOTE: Extent of Adhesion Involvement (%) = length of the incision associated with adhesions (cm) / length of initial midline incision (cm) \* 100.

Adhesion Involvement Along the Midline Incision (Percentage)

All 11 patients meet the per protocol population defined in the protocol and the statistical analysis plan.

Mobilization Time

Overall Study

Spots Global Cancer Trial Database for An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial