An Investigator-blind Multi-center Prospective Study for... | NCT01004536

Studies
An Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix)

NCT01004536

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Dec 13, 2010Estimated

Enrollment

47Estimated

Phase

Phase 4

Conditions

Hypertrophic Cicatrix

Interventions

silicone gel
no treatment

Countries

South Korea

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

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Feb 2011Estimated

Completion Date

Feb 2011Estimated

First Submitted Date

Oct 29, 2009

First Submission Date that Met QC Criteria

Oct 29, 2009

First Posted Date

Oct 30, 2009Estimated

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

Dec 9, 2010

Last Update Posted Date

Dec 13, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Samsung Medical CenterOTHER

Collaborators

Name	Class
Seoul National University Hospital	OTHER
Kyunghee University Medical Center	OTHER
Inovail	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Silicone gel is a self-drying silicone polymer that forms thin film after application onto the skin. Because silicone film is a medical device, silicone gel is also regarded as a medical device. Silicone gel has been on the market for many years for the management of scar in the phase of treatment as well as in the phase of prevention. In contrast to other methods that are expensive, invasive or inconvenient, silicone gel is convenient, non-invasive and also reasonably priced. However, the number of well-designed clinicial trials for efficacy and safety are not enough to provide robust evidences in making clinical decisions for scar management options. In a prospective, multi-center, investigator-blind randomized half-split study for patients undergoing cesarean sections, the investigators attempt to provide valid information for the efficacy and safety of silicone gel in the prevention phase of scar.

Detailed Description

Prospective subjects will be enrolled in the trial when eligibility screening and informed consent were made. One day after stitch out for cesarean sections, subjects will be asked to start applying silicone gel as the instruction to the randomly designated half of the wound 2 times a day for 12 weeks. Subjects are asked to make visits on week 4, 8, and 12 for efficacy, safety and compliance evaluations. Obstetricians, dermatologists and medical imaging specialists are involved in the trial for the evaluation of efficacy, safety and compliance. Sample size calculation as well as statistical analysis will be conducted by a designated statistician. Study product will be provided by the manufacturer at no cost and patient visits and relevant lab exams will be conducted free of charge.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
no treatment	No Intervention	The other half of cesarean section wound that is to be left untreated.	Other: no treatment
silicone gel	Experimental	Randomly-designated half of cesarean section wound that is to be subject to application ot silicone gel	Device: silicone gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
silicone gel	Device	twice daily application onto designated half of cesarean section wound for 12 weeks	silicone gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
summation of scar scores of modified Vancouver Scar Scale		week 12

Secondary Outcomes

Measure	Description	Time Frame
summation of scar scores of mVSS 4 and 8 weeks after application		weeks 4, 8, 12
scar thickness 12 weeks after application		weeks 4, 8, 12
subjective satisfaction 12 weeks after application (VAS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant female of 20-45 in ages equal to or beyond 34th of pregnancy
Those who understand and agree on the trial conditions

Exclusion Criteria:

Keloid (by present and past medical history)
Secondary infection, and/or dermatitis in and around c/s wound
Hypersensitivity to the study agent
Diabetes
(Pre)eclampsia

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joo-Heung Lee, MD	Samsung Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul	Seoul	135-710	South Korea
Kyung-Hee University Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D017439	Cicatrix, Hypertrophic

Ancestor Terms

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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