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

NCT01004536 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2010-12-13

No results posted yet for this study

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.

Conditions

  • Hypertrophic Cicatrix

Interventions

DEVICE

silicone gel

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

OTHER

no treatment

left untreated during the study period

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Kyunghee University Medical Center

    collaborator OTHER

  • Inovail

    collaborator UNKNOWN

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Joo-Heung Lee, MD · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01004536 on ClinicalTrials.gov