Cutaneous Scarring of Scalpel Versus Cautery

This study has been terminated.
(Slow accrual of subject enrollment.)
Sponsor:
Information provided by (Responsible Party):
Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:
NCT00803140
First received: December 3, 2008
Last updated: May 27, 2015
Last verified: May 2015
  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 ]

Enrollment: 4
Study Start Date: November 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803140

Locations
United States, Texas
Scott and White Hospital and Clinic
Temple, Texas, United States, 76508
Sponsors and Collaborators
Scott and White Hospital & Clinic
Investigators
Principal Investigator: Raman C Mahabir, MD Scott and White Hospital & Clinic
  More Information