LacerationsCatgutNCT00681070
Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations
A study testing Arm 2: Absorbable sutures and Arm 1: non-absorbable sutures in people with Lacerations and Wounds, run by Temple University at 2 sites in United States.
Trial summary
Our research hypothesis in this study is that there is no difference in long-term cosmetic outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric facial lacerations. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Lacerations, Wounds
- What is being tested?
- Arm 2: Absorbable sutures and Arm 1: non-absorbable sutures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clean. minimally contaminated facial lacerations, between 1-5 cms long, less than 8 hours old, not caused by animal bites, not needing plastic surgery repair
Who cannot join
- Pregnancy
- Bleeding
- Renal
- Endocrine problems
- Dirty wounds
- Irregular wounds
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Temple University Hospital
Philadelphia, Pennsylvania, 19130
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
About this study
Official title: Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations, Part 2
Our research hypothesis in this study is that there is no difference in long-term cosmetic outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric facial lacerations.
Read the detailed description
The standard method of repair for facial lacerations is to close such wounds with non-absorbable sutures. Recently, topical skin adhesives such as n-butyl-2-cyanoacrylate and 2-octyl cyanoacrylate have been used more frequently as these have been shown to be a faster and less painful way to close superficial facial lacerations. However, lacerations that are deeper, gaping or occurring along lines of excessive tension, such as the chin, still need sutures for repair. Non-absorbable sutures have to be taken out at 4-7 days. This involves another physician visit, parental absence from work, and children who need to be taken out of school or daycare for a simple suture removal.
In Part Iof the study, we were able to demonstrate non-inferiority of absorbable sutures to nylon sutures. However, we purposely removed all remaining absorbable sutures on the 5-7 day follow-up visit. In Part II, we will allow the absorbable sutures to dissolve on their own. We will again assess long term cosmetic outcomes, as well parental satisfaction, and short and long-term complication rates at 3 months.
- Conditions
- Lacerations, Wounds
- Being tested
- Arm 2: Absorbable sutures, Arm 1: non-absorbable sutures
- Keywords
- laceration, wound management, absorbable sutures, cosmetic outcomes
- 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.
Arm 2: Absorbable suturesOther
Also called fast-absorbing catgut 5-0 by Johnson and Johnson
use of absorbable catgut sutures in pediatric facial lacerations
Arm 1: non-absorbable suturesOther
Use of non-absorbing sutures
| Study group | Role | What they receive |
|---|---|---|
| Arm1: Non-absorbable sutures | Active comparator | use of non-absorbable sutures in facial laceration in this arm Receives: Other: Arm 1: non-absorbable sutures |
| Arm 2: Absorbable sutures | Active comparator | use of absorbable sutures in this arm Receives: Other: Arm 2: Absorbable sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
cosmetic outcomes
Measured: 3 months
Secondary outcomes (1)
infection
Measured: 4-6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681070
- Sponsor's protocol ID
- 11020
- Other IDs
- 11020-2
- Acronym
- Catgut
- Status last verified
- Feb 2017
- First submitted
- 19 May 2008
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations, Part 2
- ClinicalTrials.gov ID
- NCT00681070
- Acronym / sponsor ID
- Catgut / 11020
- Conditions
- Lacerations, Wounds
- Keywords
- laceration, wound management, absorbable sutures, cosmetic outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Apr 2008 (actual)
- Primary completion
- Apr 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 May 2008 (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.
Our research hypothesis in this study is that there is no difference in long-term cosmetic outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric facial lacerations.
Detailed description
The standard method of repair for facial lacerations is to close such wounds with non-absorbable sutures. Recently, topical skin adhesives such as n-butyl-2-cyanoacrylate and 2-octyl cyanoacrylate have been used more frequently as these have been shown to be a faster and less painful way to close superficial facial lacerations. However, lacerations that are deeper, gaping or occurring along lines of excessive tension, such as the chin, still need sutures for repair. Non-absorbable sutures have to be taken out at 4-7 days. This involves another physician visit, parental absence from work, and children who need to be taken out of school or daycare for a simple suture removal.
In Part Iof the study, we were able to demonstrate non-inferiority of absorbable sutures to nylon sutures. However, we purposely removed all remaining absorbable sutures on the 5-7 day follow-up visit. In Part II, we will allow the absorbable sutures to dissolve on their own. We will again assess long term cosmetic outcomes, as well parental satisfaction, and short and long-term complication rates at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1: Non-absorbable sutures | Active comparator | Other: Arm 1: non-absorbable suturesuse of non-absorbable sutures in facial laceration in this arm |
| Arm 2: Absorbable sutures | Active comparator | Other: Arm 2: Absorbable suturesuse of absorbable sutures in this arm |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clean. minimally contaminated facial lacerations, between 1-5 cms long, less than 8 hours old, not caused by animal bites, not needing plastic surgery repair
Key exclusion criteria (6 listed)
- Pregnancy
- Bleeding
- Renal
- Endocrine problems
- Dirty wounds
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 |
|---|---|---|
| Arm 2: Absorbable suturesAlso: fast-absorbing catgut 5-0 by Johnson and Johnsonuse of absorbable catgut sutures in pediatric facial lacerations | Other | Arm 2: Absorbable sutures |
| Arm 1: non-absorbable suturesUse of non-absorbing sutures | Other | Arm1: Non-absorbable sutures |
Primary outcome
cosmetic outcomes
Time frame: 3 months
1 secondary outcome
infection
Time frame: 4-6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 2: Absorbable sutures and Arm 1: non-absorbable sutures in people with Lacerations and Wounds, run by Temple University at 2 sites 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
cosmetic outcomes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2017.