ScarsNCT00803140
Cutaneous Scarring of Scalpel Versus Cautery
A study of Scars, run by Scott and White Hospital & Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scars
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary, elective panniculectomy.
- Patients must voluntarily be enrolled in the study after informed consent.
- Patients must be in relative good health and have adequate nutrition.
- Patients of all races and genders will be included.
- Patients must agree to refrain from the use of topical scar products during the study period.
Who cannot join
- Under the age of 18 years old
- Patients with previous history of hypertrophic or keloid scarring
- Patients presenting for scar revision
- Patients presenting for a non-elective surgery
- Patients with chronic immunosuppression or wound healing problems
- 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,
- Use of any tobacco products
Trial locations and contacts
1 site in 1 country.
United States1 site
Scott and White Hospital and Clinic
Temple, Texas, 76508
About this study
Official title: A Pilot Study Comparing Cutaneous Scarring When Scalpel Versus Cautery is Used to Make Skin Incisions
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.
Read the detailed description
Rationale: Most surgeons at some point have used the "cut" setting on a cautery device to make or extend an incision. Anecdotally, there does not appear to be a noticeable difference in the scarring. This opinion, however is not shared by all surgeons.
Review of the literature reveals a paucity of evidence supporting the use of cutting cautery vs. standard, scalpel incision. A study that objectively, prospectively, and randomly compares the scars between these two methods has the potential to alter the doctrine of scalpel incisions, potentially saving money, and allowing a safer operating room environment (one free of scalpels in some cases).
Objectives: To objectively compare the cutaneous scars resulting from scalpel versus cutting cautery incisions using a subjective and objective scar measurement tool.
Methodology:
Research Design: This study will be a Blinded, Prospective, Randomized Controlled Trial.
Research Participants:
Comparison Information: The patient will have ½ of the incision performed with standard scalpel incision, and the contralateral ½ of the incision with cutting cautery incision. The sides will be randomized using a random number generator. For purposes of this study, the right side of the incision is defined as the patient's right side and the left side of the incision is defined as the patient's left side.
Criteria for Discontinuation: The study will be discontinued if it becomes obvious that the cautery ½ of the incision develops increased complications relating to infections, wound breakdown, or scarring.
Observations: The patients will follow up after surgery for evaluations at 2 weeks, 3 months, 6 months, and 12 months. Patients, physicians and a blinded independent observer will evaluate the scars using a visual analogue scale at 2 weeks, 3 months, 6 months and 12 months. Also, at 12 months, the Patient and Observer Scar Assessment Tool will be used to evaluate all scars in order to provide objective and subjective scar evaluation. The subject, surgeon and blinded observer will complete this evaluation.
Sample Size: 10 patients will be enrolled in our study. The data gathered from this pilot study should provide us with the data necessary to perform a power and sample size calculation for a future randomized controlled trial.
Date Management and Analysis: At postoperative follow up visits (2 weeks +/- 4 days, 3 months +/- 2 weeks, 6 months +/- 2 weeks), the patient, physician and independent observer will evaluate the scar subjectively using a visual analogue scale measuring 10 cm in length. One side of the scale (the side nearest 0) will imply the poorest scar imaginable; the opposite side will represent the best. Measurements will be taken regarding width, and observations regarding erythema and pigment will be noted.
At the 12 month postoperative follow up, the Patient and Observer Scar Assessment Tool will be used to compare the scars in order to provide both subjective and objective data.
Ethical Considerations
Protection of Human Subjects: Approval from the IRB will be obtained prior to beginning this study. All investigators have met federal and institutional educational requirements for Human Subjects Protection.
Patients will be offered scar revisions at no additional costs to the patient on the "test" side. These scar revisions will be offered at 1 year if necessary.
- Conditions
- Scars
- Being tested
- Cautery vs Active Control Arm (Scalpel)
- Keywords
- scarring
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cautery vs Active Control Arm (Scalpel)Procedure or surgery
Also called bovie
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.
| Study group | Role | What they receive |
|---|---|---|
| Cautery Arm | Active comparator | Cautery to make skin incision Receives: Procedure: Cautery vs Active Control Arm (Scalpel) |
| Scalpel Incision | Active comparator | Scalpel to make skin incision Receives: Procedure: Cautery vs Active Control Arm (Scalpel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the Vancouver Scar Scale
Measured: 12 months
Secondary outcomes (4)
Visual scar scale done by both the subject and an independent observer
Measured: 2 week
Visual scar scale done by both the subject and an independent observer
Measured: 3 months
Visual scar scale done by both the subject and an independent observer
Measured: 6 months
Visual scar scale done by both the subject and an independent observer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Slow accrual of subject enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scott and White Hospital & Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raman C Mahabir, MD, Principal investigator, Scott and White Hospital & Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803140
- Sponsor's protocol ID
- 81818CSSvC
- Status last verified
- May 2015
- First submitted
- 3 Dec 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nguyen DQ, Potokar T, Price P. A review of current objective and subjective scar assessment tools. J Wound Care. 2008 Mar;17(3):101-2, 104-6. doi: 10.12968/jowc.2008.17.3.28666.
PubMed 18376650van Zuijlen PP, Angeles AP, Kreis RW, Bos KE, Middelkoop E. Scar assessment tools: implications for current research. Plast Reconstr Surg. 2002 Mar;109(3):1108-22. doi: 10.1097/00006534-200203000-00052.
PubMed 11884845Papay FA, Stein J, Luciano M, Zins JE. The microdissection cautery needle versus the cold scalpel in bicoronal incisions. J Craniofac Surg. 1998 Jul;9(4):344-7. doi: 10.1097/00001665-199807000-00010.
PubMed 9780929Sheikh B. Safety and efficacy of electrocautery scalpel utilization for skin opening in neurosurgery. Br J Neurosurg. 2004 Jun;18(3):268-72. doi: 10.1080/02688690410001732715.
PubMed 15327229Molgat YM, Pollack SV, Hurwitz JJ, Bunas SJ, Manning T, McCormack KM, Pinnell SR. Comparative study of wound healing in porcine skin with CO2 laser and other surgical modalities: preliminary findings. Int J Dermatol. 1995 Jan;34(1):42-7. doi: 10.1111/j.1365-4362.1995.tb04379.x.
PubMed 7896488Middleton WG, Tees DA, Ostrowski M. Comparative gross and histological effects of the CO2 laser, Nd-YAG laser, scalpel, Shaw scalpel and cutting cautery on skin in rats. J Otolaryngol. 1993 Jun;22(3):167-70.
PubMed 8371327
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing Cutaneous Scarring When Scalpel Versus Cautery is Used to Make Skin Incisions
- ClinicalTrials.gov ID
- NCT00803140
- Acronym / sponsor ID
- 81818CSSvC
- Conditions
- Scars
- Keywords
- scarring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual of subject enrollment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Scott and White Hospital & ClinicUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Most surgeons at some point have used the "cut" setting on a cautery device to make or extend an incision. Anecdotally, there does not appear to be a noticeable difference in the scarring. This opinion, however is not shared by all surgeons.
Review of the literature reveals a paucity of evidence supporting the use of cutting cautery vs. standard, scalpel incision. A study that objectively, prospectively, and randomly compares the scars between these two methods has the potential to alter the doctrine of scalpel incisions, potentially saving money, and allowing a safer operating room environment (one free of scalpels in some cases).
Objectives: To objectively compare the cutaneous scars resulting from scalpel versus cutting cautery incisions using a subjective and objective scar measurement tool.
Methodology:
Research Design: This study will be a Blinded, Prospective, Randomized Controlled Trial.
Research Participants:
Comparison Information: The patient will have ½ of the incision performed with standard scalpel incision, and the contralateral ½ of the incision with cutting cautery incision. The sides will be randomized using a random number generator. For purposes of this study, the right side of the incision is defined as the patient's right side and the left side of the incision is defined as the patient's left side.
Criteria for Discontinuation: The study will be discontinued if it becomes obvious that the cautery ½ of the incision develops increased complications relating to infections, wound breakdown, or scarring.
Observations: The patients will follow up after surgery for evaluations at 2 weeks, 3 months, 6 months, and 12 months. Patients, physicians and a blinded independent observer will evaluate the scars using a visual analogue scale at 2 weeks, 3 months, 6 months and 12 months. Also, at 12 months, the Patient and Observer Scar Assessment Tool will be used to evaluate all scars in order to provide objective and subjective scar evaluation. The subject, surgeon and blinded observer will complete this evaluation.
Sample Size: 10 patients will be enrolled in our study. The data gathered from this pilot study should provide us with the data necessary to perform a power and sample size calculation for a future randomized controlled trial.
Date Management and Analysis: At postoperative follow up visits (2 weeks +/- 4 days, 3 months +/- 2 weeks, 6 months +/- 2 weeks), the patient, physician and independent observer will evaluate the scar subjectively using a visual analogue scale measuring 10 cm in length. One side of the scale (the side nearest 0) will imply the poorest scar imaginable; the opposite side will represent the best. Measurements will be taken regarding width, and observations regarding erythema and pigment will be noted.
At the 12 month postoperative follow up, the Patient and Observer Scar Assessment Tool will be used to compare the scars in order to provide both subjective and objective data.
Ethical Considerations
Protection of Human Subjects: Approval from the IRB will be obtained prior to beginning this study. All investigators have met federal and institutional educational requirements for Human Subjects Protection.
Patients will be offered scar revisions at no additional costs to the patient on the "test" side. These scar revisions will be offered at 1 year if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cautery Arm | Active comparator | Procedure: Cautery vs Active Control Arm (Scalpel)Cautery to make skin incision |
| Scalpel Incision | Active comparator | Procedure: Cautery vs Active Control Arm (Scalpel)Scalpel to make skin incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing primary, elective panniculectomy.
- Patients must voluntarily be enrolled in the study after informed consent.
- Patients must be in relative good health and have adequate nutrition.
- Patients of all races and genders will be included.
- Patients must agree to refrain from the use of topical scar products during the study period.
Key exclusion criteria (7 listed)
- Under the age of 18 years old
- Patients with previous history of hypertrophic or keloid scarring
- Patients presenting for scar revision
- Patients presenting for a non-elective surgery
- Patients with chronic immunosuppression or wound healing problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cautery vs Active Control Arm (Scalpel)Also: bovieInterventions: 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. | Procedure or surgery | Cautery Arm, Scalpel Incision |
Primary outcome
The primary outcome measure is the Vancouver Scar Scale
Time frame: 12 months
4 secondary outcomes
Visual scar scale done by both the subject and an independent observer
Time frame: 2 week
Visual scar scale done by both the subject and an independent observer
Time frame: 3 months
Visual scar scale done by both the subject and an independent observer
Time frame: 6 months
Visual scar scale done by both the subject and an independent observer
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Slow accrual of subject enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 18376650Nguyen DQ, Potokar T, Price P. A review of current objective and subjective scar assessment tools. J Wound Care. 2008 Mar;17(3):101-2, 104-6. doi: 10.12968/jowc.2008.17.3.28666.
- Background: PubMed 11884845van Zuijlen PP, Angeles AP, Kreis RW, Bos KE, Middelkoop E. Scar assessment tools: implications for current research. Plast Reconstr Surg. 2002 Mar;109(3):1108-22. doi: 10.1097/00006534-200203000-00052.
- Background: PubMed 9780929Papay FA, Stein J, Luciano M, Zins JE. The microdissection cautery needle versus the cold scalpel in bicoronal incisions. J Craniofac Surg. 1998 Jul;9(4):344-7. doi: 10.1097/00001665-199807000-00010.
- Background: PubMed 15327229Sheikh B. Safety and efficacy of electrocautery scalpel utilization for skin opening in neurosurgery. Br J Neurosurg. 2004 Jun;18(3):268-72. doi: 10.1080/02688690410001732715.
- Background: PubMed 7896488Molgat YM, Pollack SV, Hurwitz JJ, Bunas SJ, Manning T, McCormack KM, Pinnell SR. Comparative study of wound healing in porcine skin with CO2 laser and other surgical modalities: preliminary findings. Int J Dermatol. 1995 Jan;34(1):42-7. doi: 10.1111/j.1365-4362.1995.tb04379.x.
- Background: PubMed 8371327Middleton WG, Tees DA, Ostrowski M. Comparative gross and histological effects of the CO2 laser, Nd-YAG laser, scalpel, Shaw scalpel and cutting cautery on skin in rats. J Otolaryngol. 1993 Jun;22(3):167-70.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raman C Mahabir, MD principal investigator
Scott and White Hospital & Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Scars, run by Scott and White Hospital & Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual of subject enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the Vancouver Scar Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803140, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.