Prevention of Hypertrophic Scars or Keloids

NCT00849004 | Unknown

• 1 other identifier: 97CT1018
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Keloids and hypertrophic scars are not major illness. However, their effects can be from causing pain and itch which substantially interfere daily activity to as severe as causing deformity and other functional impairment. For standard surgical wounds, taking median sternotomy wounds from open heart surgery and lower abdominal wounds from gynecological wounds for example, the incidence of these problems can be from 10% to 60%. To prevent or treat these problems, physicians have used many modalities. One of the most convenient, most cost-effective and most non-invasive methods for patients is using dressings like silicone sheets, silicone gels or paper tapes, which is on the list of 1st line choices of an international recommendation. According to a literature review, most of the previous studies on similar topics are either of small sample size, on non-standard wounds or comparisons between wounds on different patient groups. The methodologies of previous studies are thus not vigorous enough. To get the highest level of evidence on selecting the best dressings for preventing and treating keloids and hypertrophic scars, we will recruit about 75 patients and apply two selected dressings on each halves of their standard surgical wounds to compare their differences. The investigators hope the result of this study can help us find the best modality to use and can contribute to the welfare of our future patients.

Conditions

Hypertrophic Scars

Keywords

keloid; silicone sheet; silicone gel; paper tape; steri-strip

Outcome Measures

Primary Outcomes (1)

• Scar appearance measured with Vancouver Scar Scores.

  12 months

Secondary Outcomes (1)

• pain and itchiness measured with Visual Analog Scales.

  12 months

Study Arms (3)

Gel vs. Sheet

ACTIVE COMPARATOR

One group will act to compare the effectiveness between silicone gel and silicone sheet.

Other: silicone gel; Other: silicone sheet

sheet vs. paper tape

ACTIVE COMPARATOR

The second group between silicone sheet and paper tape.

Other: silicone sheet; Other: paper tape

gel vs. paper tape

ACTIVE COMPARATOR

One group will act to compare the effectiveness between silicone gel and paper tape.

Other: silicone gel; Other: paper tape

Interventions

silicone gel OTHER

silicone gel

Gel vs. Sheet; gel vs. paper tape

silicone sheet OTHER

silicone sheet

Gel vs. Sheet; sheet vs. paper tape

paper tape OTHER

paper tape

gel vs. paper tape; sheet vs. paper tape

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergo gynecological surgery with transverse lower abdominal wounds.
• Patients who undergo cardiovascular surgery with median sternotomy wounds in our hospital will be assessed.

You may not qualify if:

• Those who have or will have:
• diabetes
• chemotherapy
• radiotherapy
• known history of allergy to silicone will be excluded.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital: R.O.C.

Kaohsiung City, 813, Taiwan

Location

Related Publications (32)

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MeSH Terms

Conditions

Cicatrix, Hypertrophic; Keloid

Interventions

Silicone Gels

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Kuei-Chang Hsu, surgeon

  Department of plastic surgery in Kaohsiung Veterans General Hospital in Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Surgeon

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 23, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 22, 2012

Record last verified: 2012-10

Locations

TW (1)