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

June 2, 2020 updated by: Temple University

Comparison of Cosmetic Outcomes of Lacerations of the Trunk and Extremity Repaired Using Absorbable Versus Non-absorbable Sutures

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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: suture
non-absorable sutures and absorable sutures
Procedure: Absorbable Suture Arm
use of irradiated polyglactin 910
Other Names:
  • Vicryl Rapide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Investigators

  • Principal Investigator: Raemma p Luck, MD, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

July 2, 2009

First Submitted That Met QC Criteria

July 6, 2009

First Posted (ESTIMATE)

July 7, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12177 (REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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