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

NCT01004536 | Unknown Phase 4

• 1 other identifier: 2009-08-092
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertrophic Cicatrix

Outcome Measures

Primary Outcomes (1)

• summation of scar scores of modified Vancouver Scar Scale

  week 12

Secondary Outcomes (4)

• 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)

  weeks 4, 8, 12

• tolerability 4, 8, 12 weeks after application (index3)

  weeks 4, 8, 12

Study Arms (2)

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

silicone gel DEVICE

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

Also known as: Dermatix

silicone gel

no treatment OTHER

left untreated during the study period

no treatment

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Seoul National University Hospital: collaborator
• Kyunghee University Medical Center: collaborator
• Inovail: collaborator

Study Sites (3)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

Location

Kyung-Hee University Medical Center

Seoul, Seoul, South Korea

Location

Seoul National University Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joo-Heung Lee, MD

  Samsung Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: October 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 13, 2010

Record last verified: 2010-12

Locations

KR (3)