LacerationsNCT00933829
Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures
A study testing Absorbable Suture Arm, Non-absorbable suture (Prolene) and suture in people with Lacerations and Wounds, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lacerations, Wounds, Injuries
- What is being tested?
- Absorbable Suture Arm, Non-absorbable suture (Prolene) and suture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Isolated injury
- Non-contaminated or minimally contaminated wounds
- Linear laceration 1-5 cms
- Topical adhesives not indicated
Who cannot join
- Trunk and extremity lacerations less than 1 cm or greater than 5 cm.
- Moderately contaminated wounds or dirty wounds
- Wounds with visible foreign bodies
- Wounds more than 8 hours old
- Wounds that can be repaired using topical adhesives
- Complex wounds needing surgical referral
Show all 12Show fewer
- Wounds caused by mammalian bites
- Wounds in patients with immune deficiency, pregnancy, diabetes, suspected bleeding disorder or renal dysfunction
- Wounds in patients who are currently taking steroids
- Wounds in areas of tension such as the joint or crease
- Patients with allergic reaction to the topical anesthetic
- Irregular wounds
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: 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.
Read the 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.
- Conditions
- Lacerations, Wounds, Injuries
- Being tested
- Absorbable Suture Arm, Non-absorbable suture (Prolene), suture
- Keywords
- absorbable sutures, non-absorbable sutures, wound management
- Medical subject headings
- Lacerations, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable Suture ArmProcedure or surgery
Also called Vicryl Rapide
use of irradiated polyglactin 910
Non-absorbable suture (Prolene)Device
suture
sutureProcedure or surgery
non-absorable sutures and absorable sutures
| Study group | Role | What they receive |
|---|---|---|
| Non-absorbable arm | Placebo comparator | uses non-absorbable suture such as Prolene to repair lacerations Receives: Device: Non-absorbable suture (Prolene); Procedure: suture |
| Absorbable Suture Arm | Active comparator | uses absorbable sutures to repair lacerations Receives: Procedure: Absorbable Suture Arm; Procedure: suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale.
Measured: at least 3 months post-injury
Secondary outcomes (1)
Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury.
Measured: 8-12 days post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LacerationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raemma p Luck, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933829
- Sponsor's protocol ID
- 12177
- Status last verified
- Jun 2020
- First submitted
- 2 Jul 2009
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15620501Tejani 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.
PubMed 25039547
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cosmetic Outcomes of Lacerations of the Trunk and Extremity Repaired Using Absorbable Versus Non-absorbable Sutures
- ClinicalTrials.gov ID
- NCT00933829
- Acronym / sponsor ID
- 12177
- Conditions
- Lacerations, Wounds, Injuries
- Keywords
- absorbable sutures, non-absorbable sutures, wound management
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-absorbable arm | Placebo comparator | Device: Non-absorbable suture (Prolene), Procedure: sutureuses non-absorbable suture such as Prolene to repair lacerations |
| Absorbable Suture Arm | Active comparator | Procedure: Absorbable Suture Arm, Procedure: sutureuses absorbable sutures to repair lacerations |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Isolated injury
- Non-contaminated or minimally contaminated wounds
- Linear laceration 1-5 cms
- Topical adhesives not indicated
Key exclusion criteria (12 listed)
- Trunk and extremity lacerations less than 1 cm or greater than 5 cm.
- Moderately contaminated wounds or dirty wounds
- Wounds with visible foreign bodies
- Wounds more than 8 hours old
- Wounds that can be repaired using topical adhesives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorbable Suture ArmAlso: Vicryl Rapideuse of irradiated polyglactin 910 | Procedure or surgery | Absorbable Suture Arm |
| Non-absorbable suture (Prolene)suture | Device | Non-absorbable arm |
| suturenon-absorable sutures and absorable sutures | Procedure or surgery | Absorbable Suture Arm, Non-absorbable arm |
Primary outcome
The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale.
Time frame: at least 3 months post-injury
1 secondary outcome
Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury.
Time frame: 8-12 days post-injury
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Results publication: PubMed 15620501Al-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.
- Derived from this study: PubMed 25039547Tejani 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.
- abstract of Vicryl Rapide and RCTLink provided by the sponsor.
- use of absorbable sutures in pediatric facial lacerationsLink provided by the sponsor.
- review of wound management, suturesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raemma p Luck, MD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable Suture Arm, Non-absorbable suture (Prolene) and suture in people with Lacerations and Wounds, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale. (time frame: at least 3 months post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00933829, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.