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

NCT ID: NCT01004536

Last Updated: 2010-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-02-28

Brief Summary

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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

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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.

Conditions

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Hypertrophic Cicatrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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no treatment

The other half of cesarean section wound that is to be left untreated.

Group Type NO_INTERVENTION

no treatment

Intervention Type OTHER

left untreated during the study period

silicone gel

Randomly-designated half of cesarean section wound that is to be subject to application ot silicone gel

Group Type EXPERIMENTAL

silicone gel

Intervention Type DEVICE

twice daily application onto designated half of cesarean section wound for 12 weeks

Interventions

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silicone gel

twice daily application onto designated half of cesarean section wound for 12 weeks

Intervention Type DEVICE

no treatment

left untreated during the study period

Intervention Type OTHER

Other Intervention Names

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Dermatix

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role collaborator

Inovail

UNKNOWN

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Principal Investigators

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Joo-Heung Lee, MD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, Seoul, South Korea

Site Status

Kyung-Hee University Medical Center

Seoul, Seoul, South Korea

Site Status

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2009-08-092

Identifier Type: -

Identifier Source: org_study_id