## Protocol Section
### Identification Module
**NCT ID:** NCT00778479

**Brief Title:** Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

**Official Title:** Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

#### Organization Study ID Info
**ID:** SSPRAY00508
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
### Status Module
#### Completion Date
**Date:** 2009-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-03-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-03-19

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2009-05

**Type:** ACTUAL

#### Start Date
**Date:** 2008-10

**Status Verified Date:** 2015-03

#### Study First Post Date
**Date:** 2008-10-23
**Type:** ESTIMATED
**Study First Submit Date:** 2008-10-22
**Study First Submit QC Date:** 2008-10-22
**Why Stopped:** Terminated by Sponsor: see details below
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Genzyme, a Sanofi Company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery

NOTE regarding reason for study termination:

A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor.

A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.

### Conditions Module

**Conditions:**

- Adhesion Prevention (Abdominal)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 155

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Receive Sepraspray

**Intervention Names:**

- Device: Sepraspray

**Label:** Sepraspray

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** no treatment

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sepraspray

**Description:** Max. 10g of Sepraspray

**Name:** Sepraspray

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Morbidity

**Time Frame:** 30 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients 18 years old and over that require open abdominal surgery

Exclusion Criteria:

* Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Clamond

**Country:** France

**Facility:** Chu Hotel Dieu

**Location 2:**

**City:** Lille

**Country:** France

**Facility:** CHRU de Lille, Hopital Huriez

**Location 3:**

**City:** Lyon

**Country:** France

**Facility:** Hopital de la Croix Rousse

**Location 4:**

**City:** Paris

**Country:** France

**Facility:** Hopital Lariboisiere

**Location 5:**

**City:** Linkoping

**Country:** Sweden

**Facility:** University Hospital

**Location 6:**

**City:** Stockholm

**Country:** Sweden

**Facility:** Karolinska University Hospital

**Location 7:**

**City:** Uppsala

**Country:** Sweden

**Facility:** Akademiska Sjukhuset

#### Overall Officials

**Official 1:**

**Affiliation:** Genzyme, a Sanofi Company

**Name:** Medical Monitor

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002921

- Term: Cicatrix

- ID: D000005355

- Term: Fibrosis

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3620

- Name: Tissue Adhesions

- Relevance: HIGH

- As Found: Adhesion

- ID: M6160

- Name: Cicatrix

- Relevance: LOW

- As Found: Unknown

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000267

- Term: Tissue Adhesions

### Misc Info Module

- Version Holder: 2024-05-24
