Effect of Vitamin E-containing Dressing on Surgical Site... | NCT03443141

Studies
Effect of Vitamin E-containing Dressing on Surgical Site Infection in Colorectal Surgery

NCT03443141

Sponsor

Hospital General Universitario Elche

Status

Unknown status

Last Update Posted

Feb 22, 2018Actual

Enrollment

120Estimated

Phase

Phase 3

Conditions

Surgical Site Infection

Interventions

Vitamin E
Standard dressing

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Mar 30, 2018Estimated

Completion Date

Mar 30, 2018Estimated

First Submitted Date

Feb 16, 2018

First Submission Date that Met QC Criteria

Feb 16, 2018

First Posted Date

Feb 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2018

Last Update Posted Date

Feb 22, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jaime Ruiz-Tovar, MD, PhD, Professor of Surgery, Hospital General Universitario ElchePrincipal Investigator

Lead Sponsor

Hospital General Universitario ElcheOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective, randomized study will be performed. Patients are randomized using a 1:1 allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a conventional dressing (group 2). The primary outcomes variable will be occurrence of incisional SSI. Follow-up will be 30 days postoperatively.

Detailed Description

A prospective, randomized study will be performed. Patients are randomized using a random number table into 1:1 allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a conventional dressing (group 2). In group 1 the wound will be covered with a Vitamin E embebbed gauze and plastic adhesive tape. In Group 2, , the wound will be covered with standard gauze and plastic adhesive tape.

The primary outcomes variable will be occurrence of incisional SSI, defined by CDC criteria. Follow-up will be 30 days postoperatively.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin E dressing	Experimental	Patients will receive a Vitamin E-containing dressing over the wound	Drug: Vitamin E
Standard dressing	Sham Comparator	Patients will receive a standard dressing over the wound	Drug: Standard dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin E	Drug	The applied dressing will be embebbed in Vitamin E	Vitamin E dressing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incisional surgical site infection	Patients present a wound with the CDC criteria for SSI	30 days postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of colorectal neoplasms
plan to undergo an elective operation with curative aims
laparoscopic surgery

Exclusion Criteria:

Anastomotic leak
Lost to 30-days follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jaime Ruiz-Tovar	Contact	630534808		jruiztovar@gmail.com
Manuel Duran, MD, PhD	Contact

Overall Officials

Name	Affiliation	Role
Damian Garcia-Olmo, MD, PhD	HOSPITAL REY JUAN CARLOS	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital general Universitario de Elche	Recruiting	Elche	Alicante	03202	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014810	Vitamin E
D035061	Control Groups

Ancestor Terms

ID	Term
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided