## Protocol Section
### Identification Module
**NCT ID:** NCT00940979

**Acronym:** ITT

**Brief Title:** Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities

**Official Title:** Prospective Randomised Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities

#### Organization Study ID Info
**ID:** LTC 625-230609
#### Organization
**Class:** OTHER
**Full Name:** Rijnstate Hospital
### Status Module
#### Completion Date
**Date:** 2011-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-01-13

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-01-10

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2011-04

**Type:** ACTUAL

#### Start Date
**Date:** 2010-01

**Status Verified Date:** 2014-01

#### Study First Post Date
**Date:** 2009-07-17
**Type:** ESTIMATED
**Study First Submit Date:** 2009-07-16
**Study First Submit QC Date:** 2009-07-16
**Why Stopped:** Interim analyses showed insufficient result. Termination for reasons of futility
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Kimberly-Clark Corporation

#### Lead Sponsor

**Class:** OTHER

**Name:** Rijnstate Hospital

### Description Module

**Brief Summary:** The purpose of this study is to prove a reduction of postoperative wound infections after direct preoperative use of a microbial sealant in the form of Integuseal for vascular procedures on lower extremities.

### Conditions Module

**Conditions:**

- Arterial Obstructive Diseases

**Keywords:**

- Integuseal microbial sealant

- Infection prophylaxis

- Postoperative wound infection

- Arterial bypass surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 450

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** No use of integuseal

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Application of a layer of Integuseal (Cyanoacrylate) from a ready to use applicator preoperative before incision Polymerisation immobilise the bacteria that survived the conventional skin preparation This way there will be les contamination of the wound.

**Intervention Names:**

- Procedure: Application of Integuseal sealant

**Label:** Use of Integuseal

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Use of Integuseal

**Description:** Microbial sealant (integuseal) applied with a sponge applicator

**Name:** Application of Integuseal sealant

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Postoperative wound infections

#### Secondary Outcomes

**Measure:** Costs of the use of Integuseal

**Measure:** Complications during hospital stay

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft

Exclusion Criteria:

* secondary procedures and suprainguinal procedures

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Arnhem

**Country:** Netherlands

**Facility:** Ziekenhuis Rijnstate

**Zip:** 6800 TA

**Location 2:**

**City:** Doetinchem

**Country:** Netherlands

**Facility:** Ziekenhuis Slingland

**Location 3:**

**City:** Drachten

**Country:** Netherlands

**Facility:** Ziekenhuis Nij Smellinghe

#### Overall Officials

**Official 1:**

**Affiliation:** Rijstate hospital Arnhem the Netherlands

**Name:** Michel MPJ Reijnen, MD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Name:** J. Klinkenbijl, MD

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Rijnstate Hospital Arnhem the Netherlands

**Name:** Sjoerd A de Beer, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17684

- Name: Wound Infection

- Relevance: LOW

- As Found: Unknown

- ID: M16310

- Name: Surgical Wound Infection

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: HIGH

- As Found: Arterial Obstructive Disease

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001157

- Term: Arterial Occlusive Diseases

### Misc Info Module

- Version Holder: 2024-05-24
