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Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures

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ClinicalTrials.gov Identifier: NCT00933829
Recruitment Status : Withdrawn
First Posted : July 7, 2009
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Temple University

Brief Summary:
The primary objective of this prospective, randomized study is to compare cosmetic outcomes between absorbable and non-absorbable sutures in truncal and extremity lacerations in the pediatric and adult population. Secondary outcome measures include wound complications such as infection and wound dehiscence at the initial visit; and parental satisfaction and keloid formation after three months post repair.

Condition or disease Intervention/treatment Phase
Lacerations Wounds Injuries Procedure: Absorbable Suture Arm Device: Non-absorbable suture (Prolene) Procedure: suture Not Applicable

Detailed Description:
Even though there some studies showing good outcomes using absorbable sutures in skin closure in clean surgical wounds, ED based studies still need to be conducted to convince ED physicians that the use of absorbable sutures to close the skin in traumatic lacerations are just as acceptable as traditional non-absorbable sutures. Use of absorbable sutures confers several advantages over non-absorbable sutures. For one, patients do not need an additional physician visit either in the office, or more often that not, in the emergency department. These visits add to ED overcrowding, prolonged length of ED stay and are often not reimbursed if seen in the emergency department. Moreover, adult patients need to miss work or school and children often have to miss school or daycare to have these sutures removed. The potential to avert another traumatic experience from suture removal in children who had been restrained for suture placement is another advantage of using absorbable sutures over non-absorbable sutures.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Cosmetic Outcomes of Lacerations of the Trunk and Extremity Repaired Using Absorbable Versus Non-absorbable Sutures
Study Start Date : April 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Tears

Arm Intervention/treatment
Placebo Comparator: Non-absorbable arm
uses non-absorbable suture such as Prolene to repair lacerations
Device: Non-absorbable suture (Prolene)
suture

Procedure: suture
non-absorable sutures and absorable sutures

Active Comparator: Absorbable Suture Arm
uses absorbable sutures to repair lacerations
Procedure: Absorbable Suture Arm
use of irradiated polyglactin 910
Other Name: Vicryl Rapide

Procedure: suture
non-absorable sutures and absorable sutures




Primary Outcome Measures :
  1. The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale. [ Time Frame: at least 3 months post-injury ]

Secondary Outcome Measures :
  1. Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury. [ Time Frame: 8-12 days post-injury ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Isolated injury
  2. Non-contaminated or minimally contaminated wounds
  3. Linear laceration 1-5 cms
  4. Topical adhesives not indicated

Exclusion Criteria:

  1. Trunk and extremity lacerations less than 1 cm or greater than 5 cm.
  2. Moderately contaminated wounds or dirty wounds
  3. Wounds with visible foreign bodies
  4. Wounds more than 8 hours old
  5. Wounds that can be repaired using topical adhesives
  6. Complex wounds needing surgical referral
  7. Wounds caused by mammalian bites
  8. Wounds in patients with immune deficiency, pregnancy, diabetes, suspected bleeding disorder or renal dysfunction
  9. Wounds in patients who are currently taking steroids
  10. Wounds in areas of tension such as the joint or crease
  11. Patients with allergic reaction to the topical anesthetic
  12. Irregular wounds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933829


Locations
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United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Investigators
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Principal Investigator: Raemma p Luck, MD Temple University
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00933829    
Other Study ID Numbers: 12177
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Keywords provided by Temple University:
absorbable sutures
non-absorbable sutures
wound management
Additional relevant MeSH terms:
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Lacerations
Wounds and Injuries