Cutaneous Scarring of Scalpel Versus Cautery
| Status: | Completed |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | November 2008 |
| End Date: | August 2011 |
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.
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.
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.
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.
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
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