Manageability and Safety Assessment of Sepraspray in Abdominal Surgery. (C-MUST)

Genzyme

Status: Completed

Conditions: Adhesion Prevention

Treatments: Device: Sepraspray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813397

SSPRAY00608

Details and patient eligibility

About

This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years old and over that require laparoscopic abdominal surgery

Exclusion criteria

• Patients who are pregnant or have an ongoing infectious complications from a previous surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

Sepraspray

Experimental group

Description:

Receive Sepraspray

Treatment:

Device: Sepraspray

Control

No Intervention group

Description:

No Treatment, No Placebo