Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches
Study Details
Study Description
Brief Summary
There are several methods of closing a skin cut: stitches, skin glue, and medical tape. Stitches have been used for a long time to close skin cuts. Skin glue (invented in the 1970s) and medical tape (invented in the 1960s) are two newer methods to close skin cuts. The purpose of this study is to find out which method (stitches, skin glue, or medical tape) of closing skin cuts results in the least amount of scarring. Other things the investigators will be looking at are which method is the cheapest, which causes the least pain, which requires the least amount of sedation, and which method patients and parents like the best.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
When a child comes in to the Emergency Room with a skin cut, if the child and their parents consent to being in the study, they will be randomly assigned to one of three groups: stitches, skin glue, or medical tape. There will be about 30 kids in each group, and thus 90 kids total in the study.
In the Emergency Room, a lidocaine ointment will be placed on the child's cut to decrease pain. The cut will be cleaned out with sterile saline. Then, depending on which method is used, the cut will be closed with either stitches, skin glue, or medical tape by their doctor. The participants will be asked to answer a short questionnaire. Finally, they will be given discharge instructions and sent home. At 3 months, the investigators will call parents for a quick questionnaire over the phone and parents will be asked to take a picture of the patient's scar and send it to the study staff.
Once all 90 pictures have been collected, two Plastic Surgeons will be asked to rate the scars in terms of how they look. The Plastic Surgeons will not know which method was used to close which cut. Once all of the scars have been rated, the averages of scars will be compared for each closure method. The investigators will also look at how much each method cost, how much extra pain medications or sedation each group used, and which method was liked best.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Absorbable Sutures 30 patients will have their laceration closed with sutures that absorb on their own and do not need to be removed. |
Procedure: Absorbable Sutures
The patient's doctor will close the patient's laceration with absorbable sutures.
Other Names:
|
| Experimental: Steri-Strips 30 patients will have their laceration closed with a special medical tape called "Steri-Strips." |
Procedure: Steri-Strips
The patient's doctor will close the patient's laceration with Steri-Strips.
Other Names:
|
| Experimental: Dermabond 30 patients will have their laceration closed with a special skin glue called "Steri-Strips." |
Procedure: Dermabond
The patient's doctor will close the patient's laceration with Dermabond.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cosmetic outcome [3 months]
Two blinded Plastic Surgeons will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "worst scar" and a score of 100 corresponding to "best scar"
Secondary Outcome Measures
- Pain experienced by patient [Initial Emergency Room visit]
Patients aged 3 to 12 years of age will be asked to rate their pain on a Wong-Baker FACES® Pain Rating Scale. Patients aged 12 to 18 years of age will be asked to rate their pain using a 100 mm Visual Analogue Scale with a score of 0 corresponding to "No pain" and a score of 100 corresponding to "Terrible pain." Parents and providers will each be asked to score how much pain they felt the patient experienced on the same Visual Analogue Scale.
- Need for extra pain meds or sedation [Initial Emergency Room visit]
Study staff observing the procedure will record whether patients needed extra pain medications or sedation.
- Length of procedure [Initial Emergency Room visit]
Study staff observing the procedure will record how long, in minutes, the procedure of closing the laceration lasted.
- Cost of visit [Initial Emergency Room visit]
Using data in the patient's Electronic Medical Record and the Billing Department, the cost of the visit will be recorded.
- Length of Emergency Room stay [Initial Emergency Room visit]
Using data in the patient's Electronic Medical Record, the total length of the patient's Emergency Room stay will be recorded.
- Resource utilization [Initial Emergency Room visit]
Study staff observing the procedure will record how many personnel were needed in the room to keep the child calm or still.
- Likelihood that parent would recommend laceration closure method [Initial Emergency Room visit]
Parents will be asked to rate how likely they would be to recommend the closure method used for their child using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "Extremely unlikely" and a score of 100 corresponding to "Extremely likely"
- Complications [3 months]
Parents will be asked by phone at 3 months if there were any complications with their child's cut (infection, opening of the wound, etc.).
- Poor cosmetic outcome [3 months]
If a scar is rated an average of 35 or less by the Plastic Surgeons on the 100 mm Visual Analogue Scale, they will be deemed to have had a "poor cosmetic outcome."
- Presence of train tracks [3 months]
Plastic Surgeons will record if a laceration appears to have "train tracks" (or small dots on either side of a scar, all along the scar, usually caused by stitches) as they are rating each scar.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Medical complaint of laceration
-
Single, linear laceration
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Laceration less than 5 cm in length and 0.5 cm in width
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Laceration less than 12 hours old
-
Laceration minimally contaminated (no visible dirt in wound)
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Parents and child speak English
Exclusion Criteria:
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Significant medical history that may impact wound healing (hematologic or oncologic diagnosis requiring chemotherapy, ichthyosis, epidermolysis bullosa, etc.)
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Use of oral steroids (more than 5 days in the past month)
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History of keloid formation
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Allergy to skin glue, medical tape, or topical anesthetics
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Lacerations requiring deep sutures
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Lacerations caused by animal bites or scratches
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Lacerations located on the scalp, eyebrow, eyelid, lip, mucosa, joint or nail bed
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No access to photographic capabilities (camera or smartphone) and/or e-mail, OR unable to return to the Vanderbilt Children's Hospital Emergency Room to have a picture taken at 3 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt Children's Hospital | Nashville | Tennessee | United States | 37212 |
Sponsors and Collaborators
- Vanderbilt University Medical Center
Investigators
- Principal Investigator: Maureen Saint Georges Chaumet, MD, Vanderbilt University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 171108