Clinical trial NCT00933829: Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures
Official title: Comparison of Cosmetic Outcomes of Lacerations of the Trunk and Extremity Repaired Using Absorbable Versus Non-absorbable Sutures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lacerations
Wounds
Injuries
Keywords: absorbable sutures
non-absorbable sutures
wound management
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale.
timeFrame: at least 3 months post-injury
Secondary outcomes:
measure: Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury.
timeFrame: 8-12 days post-injury
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Raemma p Luck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Qattan MM. Vicryl Rapide versus Vicryl suture in skin closure of the hand in children: a randomized prospective study. J Hand Surg Br. 2005 Feb;30(1):90-1. doi: 10.1016/j.jhsb.2004.08.005.
citation: Tejani C, Sivitz AB, Rosen MD, Nakanishi AK, Flood RG, Clott MA, Saccone PG, Luck RP. A comparison of cosmetic outcomes of lacerations on the extremities and trunk using absorbable versus nonabsorbable sutures. Acad Emerg Med. 2014 Jun;21(6):637-43. doi: 10.1111/acem.12387.