A Randomized Controlled Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using a Tissue Adhesive (Dermabond™) Versus Adhesive Strips (Steri-Strips™) Versus Absorbable Sutures

Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches



Sponsors


Source

Vanderbilt University Medical Center

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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 we 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.

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 to 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 patient and parents will be asked to answer a short questionnaire. Finally, they
will be given discharge instructions and sent home. At 3 months, study staff 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. We 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.

Overall Status

Not yet recruiting

Start Date

2017-09-01

Completion Date

2019-01-01

Primary Completion Date

2018-08-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Cosmetic outcome
3 months

Secondary Outcome

Measure

Time Frame

Pain experienced by patient
Initial Emergency Room visit
Need for extra pain meds or sedation
Initial Emergency Room visit
Length of procedure
Initial Emergency Room visit
Cost of visit
Initial Emergency Room visit
Length of Emergency Room stay
Initial Emergency Room visit
Resource utilization
Initial Emergency Room visit
Likelihood that parent would recommend laceration closure method
Initial Emergency Room visit
Complications
3 months
Poor cosmetic outcome
3 months
Presence of train tracks
3 months

Enrollment

90

Condition


Intervention

Intervention Type

Procedure

Intervention Name


Description

The patient's doctor will close the patient's laceration with absorbable sutures.

Arm Group Label

Absorbable Sutures

Other Name

Stitches


Intervention Type

Procedure

Intervention Name


Description

The patient's doctor will close the patient's laceration with Steri-Strips.

Arm Group Label

Steri-Strips

Other Name

Medical tape


Intervention Type

Procedure

Intervention Name


Description

The patient's doctor will close the patient's laceration with Dermabond.

Arm Group Label

Dermabond

Other Name

Skin glue



Eligibility

Criteria

Inclusion Criteria:

- Medical complaint of laceration

- Single, linear laceration

- Laceration less than 5 cm in length and 0.5 cm in width

- Laceration less than 12 hours old

- Laceration minimally contaminated (no visible dirt in wound)

- Parents and child speak English

Exclusion Criteria:

- Significant medical history that may impact wound healing (hematologic or oncologic
diagnosis requiring chemotherapy, ichthyosis, epidermolysis bullosa, etc.)

- Use of oral steroids (more than 5 days in the past month)

- History of keloid formation

- Allergy to skin glue, medical tape, or topical anesthetics

- Lacerations requiring deep sutures

- Lacerations caused by animal bites or scratches

- Lacerations located on the scalp, eyebrow, eyelid, lip, mucosa, joint or nail bed

- 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

Gender

All

Minimum Age

N/A

Maximum Age

18 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Maureen Saint Georges Chaumet, MD
Principal Investigator
Vanderbilt University Medical Center

Overall Contact

Last Name

Maureen Saint Georges Chaumet, MD

Phone

615-936-7317

Email



Location

Facility

Status

Vanderbilt Children's Hospital
Nashville Tennessee 37212 United States
Not yet recruiting

Location Countries

Country

United States


Verification Date

2017-09-01

Lastchanged Date

2017-09-10

Firstreceived Date

2017-09-10

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Vanderbilt University Medical Center

Investigator Full Name

Maureen Saint georges chaumet

Investigator Title

Pediatric Emergency Fellow


Has Expanded Access

No

Condition Browse


Number Of Arms

3

Arm Group

Arm Group Label

Absorbable Sutures

Arm Group Type

Active Comparator

Description

30 patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.


Arm Group Label

Steri-Strips

Arm Group Type

Experimental

Description

30 patients will have their laceration closed with a special medical tape called "Steri-Strips."


Arm Group Label

Dermabond

Arm Group Type

Experimental

Description

30 patients will have their laceration closed with a special skin glue called "Steri-Strips."



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Single (Outcomes Assessor)

Masking Description

The Plastic Surgeons who rate all 90 scars at the end of the study are blinded to the closure method.



ClinicalTrials.gov processed this data on September 12, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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