Trial record 15 of 121 for:    Open Studies | "Cicatrix"

Cutaneous Scarring of Scalpel Versus Cautery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Scott and White Hospital & Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:
NCT00803140
First received: December 3, 2008
Last updated: February 25, 2011
Last verified: September 2010
  Purpose

Cutaneous scarring after elective surgery is a concern for surgeons of all types, perhaps even more so to plastic surgeons. Cautery is often used on the "cut" setting to make or extend incisions; however very few studies have looked at the results of these scars. The investigators' study aims are to compare standard scalpel incisions versus cautery incisions and to objectively compare the resultant scars in a prospective, randomized, controlled fashion.


Condition Intervention
Scars
Procedure: Cautery vs Active Control Arm (Scalpel)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Pilot Study Comparing Cutaneous Scarring When Scalpel Versus Cautery is Used to Make Skin Incisions

Resource links provided by NLM:


Further study details as provided by Scott and White Hospital & Clinic:

Primary Outcome Measures:
  • The primary outcome measure is the Vancouver Scar Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual scar scale done by both the subject and an independent observer [ Time Frame: 2 week ] [ Designated as safety issue: No ]
  • Visual scar scale done by both the subject and an independent observer [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Visual scar scale done by both the subject and an independent observer [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Visual scar scale done by both the subject and an independent observer [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cautery Arm
Cautery to make skin incision
Procedure: Cautery vs Active Control Arm (Scalpel)

Interventions: The cautery used will be the standard operating room monopolar cautery used at our institution. The cautery will be used on a "cut" setting of 20 with a blend setting of zero (pure cut). A standard protected needle tip cautery will be used.

A #15 blade carbon steel scalpel blade will be used on ½ of the incision; a cautery device with the above-mentioned settings will be used on the other ½ of the wound. The patient will be randomly assigned to receive the cautery incision on the left or right side. The same surgeon will make all of the skin incisions and perform the skin closures in order to provide as much standardization as possible.

The closure will be standardized.

Other Name: bovie
Active Comparator: Scalpel Incision
Scalpel to make skin incision
Procedure: Cautery vs Active Control Arm (Scalpel)

Interventions: The cautery used will be the standard operating room monopolar cautery used at our institution. The cautery will be used on a "cut" setting of 20 with a blend setting of zero (pure cut). A standard protected needle tip cautery will be used.

A #15 blade carbon steel scalpel blade will be used on ½ of the incision; a cautery device with the above-mentioned settings will be used on the other ½ of the wound. The patient will be randomly assigned to receive the cautery incision on the left or right side. The same surgeon will make all of the skin incisions and perform the skin closures in order to provide as much standardization as possible.

The closure will be standardized.

Other Name: bovie

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Inclusion Criteria:

  1. Patients undergoing primary, elective panniculectomy.
  2. Patients must voluntarily be enrolled in the study after informed consent.
  3. Patients must be in relative good health and have adequate nutrition.
  4. Patients of all races and genders will be included.
  5. Patients must agree to refrain from the use of topical scar products during the study period.

Exclusion Criteria:

  1. Under the age of 18 years old
  2. Patients with previous history of hypertrophic or keloid scarring
  3. Patients presenting for scar revision
  4. Patients presenting for a non-elective surgery
  5. Patients with chronic immunosuppression or wound healing problems
  6. Currently taking medications that interfere with wound healing such as corticosteroids, anti-coagulants (aspirin or NSAIDs), vasoconstricting agents (adrenaline or ergotrate), anti-cancer drugs, or colchicine for gout,
  7. Use of any tobacco products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803140

Locations
United States, Texas
Scott and White Hospital and Clinic Recruiting
Temple, Texas, United States, 76508
Contact: JoAnn Nichols    254-724-9187    jnichols@swmail.sw.org   
Principal Investigator: Raman C Mahabir, MD         
Sponsors and Collaborators
Scott and White Hospital & Clinic
Investigators
Principal Investigator: Raman C Mahabir, MD Scott and White Hospital & Clinic
  More Information

Publications:
Responsible Party: Raman Chaos Mahabir, MD, MSc, FRCSC, Scott and White Hospital
ClinicalTrials.gov Identifier: NCT00803140     History of Changes
Other Study ID Numbers: 81818CSSvC
Study First Received: December 3, 2008
Last Updated: February 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Scott and White Hospital & Clinic:
scarring

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014