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

Primary Purpose

Laceration

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Absorbable Sutures
Steri-Strips
Dermabond
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laceration

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Absorbable Sutures

Steri-Strips

Dermabond

Arm Description

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

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

Patients will have their laceration closed with a special skin glue called "Dermabond"

Outcomes

Primary Outcome Measures

Cosmetic Outcome of Scar at 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 as Reported by Parent
Parents will each be asked to score how much pain they felt the patient experienced 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."
Satisfaction With Time in the Emergency Department
Parents will report their satisfaction with Emergency Department length of stay using a 100-point visual analog scale with "100" meaning completely satisfied and "0" meaning not at all satisfied
Likelihood That Parent Would Recommend Laceration Closure Method
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"
Number of Complications of the Wound Site
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.). Investigators will count the number of complications reported.
Parental Reported Satisfaction With the Cosmetic Appearance of the Scar
Parents 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".
Presence of Train Tracks at the Scar Site
Plastic Surgeons will record if a scar 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 photo of the scar at 3 months post-closure. Surgeons will answer "yes" or "no".

Full Information

First Posted
September 10, 2017
Last Updated
September 7, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03280628
Brief Title
Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches
Official Title
A Randomized Controlled Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using a Tissue Adhesive (Dermabond™) Versus Adhesive Strips (Steri-Strips™) Versus Absorbable Sutures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
The COVID-19 pandemic made prospective enrollment no longer possible
Study Start Date
September 23, 2017 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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 a goal of 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The Plastic Surgeons who rate all scars at the end of the study are blinded to the closure method.
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Absorbable Sutures
Arm Type
Active Comparator
Arm Description
Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.
Arm Title
Steri-Strips
Arm Type
Experimental
Arm Description
Patients will have their laceration closed with a special medical tape called "Steri-Strips."
Arm Title
Dermabond
Arm Type
Experimental
Arm Description
Patients will have their laceration closed with a special skin glue called "Dermabond"
Intervention Type
Procedure
Intervention Name(s)
Absorbable Sutures
Other Intervention Name(s)
Stitches
Intervention Description
The patient's doctor will close the patient's laceration with absorbable sutures.
Intervention Type
Procedure
Intervention Name(s)
Steri-Strips
Other Intervention Name(s)
Medical tape
Intervention Description
The patient's doctor will close the patient's laceration with Steri-Strips.
Intervention Type
Procedure
Intervention Name(s)
Dermabond
Other Intervention Name(s)
Skin glue
Intervention Description
The patient's doctor will close the patient's laceration with Dermabond.
Primary Outcome Measure Information:
Title
Cosmetic Outcome of Scar at 3 Months
Description
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"
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain Experienced by Patient as Reported by Parent
Description
Parents will each be asked to score how much pain they felt the patient experienced 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."
Time Frame
Baseline
Title
Satisfaction With Time in the Emergency Department
Description
Parents will report their satisfaction with Emergency Department length of stay using a 100-point visual analog scale with "100" meaning completely satisfied and "0" meaning not at all satisfied
Time Frame
Baseline to wound closure, up to 30 minutes
Title
Likelihood That Parent Would Recommend Laceration Closure Method
Description
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"
Time Frame
Post-wound closure, approximately 30 minutes
Title
Number of Complications of the Wound Site
Description
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.). Investigators will count the number of complications reported.
Time Frame
3 months
Title
Parental Reported Satisfaction With the Cosmetic Appearance of the Scar
Description
Parents 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".
Time Frame
3 months
Title
Presence of Train Tracks at the Scar Site
Description
Plastic Surgeons will record if a scar 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 photo of the scar at 3 months post-closure. Surgeons will answer "yes" or "no".
Time Frame
3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly R Hanson, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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