Inguinal IncisionsNCT00909805
Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence
A study testing cutaneous suture (Surjet) and 2-octyl-cyanoacrylate (Dermabond® glue) in people with Inguinal Incisions, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial summary
Inguinal incisions are the most frequent incisions used in children before the acquisition of continence (180 incisions per year for the Pediatric Surgery Department in Nice CHU). Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Inguinal Incisions
- What is being tested?
- cutaneous suture (Surjet) and 2-octyl-cyanoacrylate (Dermabond® glue)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 4 sitesFrance
- Study dates
- Sep 2009to Jun 2018
- 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 Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children less than 24 months old
- Continuous nappies wearing for non-acquisition of continence
- Need of a surgical intervention which entry way is an inguinal incision in the inguinal fold (POTTS incision) for the following indications:
- inguinal hernia
- testicular ectopy
- hydrocele
Show all 10Show fewer
- chord cyst
- Surgical incision smaller than 5 cm
- Informed consent form signed by both parents or by the legal representative
- Patient affiliated to French national health and pensions organization
Who cannot join
- Chronic or acute dermatological affection that can hamper wound-healing (atopic pathology, infectious pathology…)
- General affection that can hamper wound-healing (chronic denutrition)
- Cutaneous infection at the incision site
- Scar in the concerned region
- Medical history of wound-healing trouble
- Digestive pathology causing chronic or acute diarrhea
Show all 10Show fewer
- Allergy to one of the used compounds (glue, string, wound dressing)
- Operative indication set in emergency with immediate surgery
- Non-acceptance of the protocol, refusal to participate to the study by one of the parents or the legal representative
- Impossibility of doing the follow up of the child, in accordance with the pre-established rules of the protocol
Trial locations and contacts
4 sites in 1 country.
France4 sites
Assistance Publique Hopitaux de Marseille - Hôpital Timone Enfants
Marseille, Bouches Du Rhône, 13000
Centre Hospitalier Universitaire de Montpellier - Hôpital Lapeyronie
Montpellier, Hérault, 34000
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet2
Nice, Alpes Maritimes, 06000
Fondation Lenval -Hôpital Pédiatrique
Nice, Alpes Maritimes, 06000
About this study
Official title: Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence. Randomised, Prospective, Non-inferiority Study.
Inguinal incisions are the most frequent incisions used in children before the acquisition of continence (180 incisions per year for the Pediatric Surgery Department in Nice CHU). However, healing of those wounds can be made hard because of soiling induced by urine and/or stool, which is unavoidable in case of wearing nappies.
Nowadays, in order to overcome a possible contamination of the surgical wound, post-surgery wound dressing is protected by the application of a waterproof band aid (like Tegaderm®) during wound-healing (evaluated to a mean of 7 days). When the band aid is soiled, a nurse changes it, causing unpleasantness in low age children (whose epidermal fragility is well known), and sometimes parents worry.
Read more
Moreover, those occlusive wound dressings avoid any control of the surgical wound during healing phase.
At the end of the wound-healing time, wound dressings are removed, causing discomfort for children and necessity of a qualified nurse staff at visit times.
Cutaneous use glues, introduced in surgery more than 10 years ago, allow making waterproof and transparent sutures, with a firmness equivalent to a 2/0 string suture (cutaneous suture in children is made with 5/0) and has its own local antiseptic properties. It does not need to be covered by any wound dressing during wound-healing phase. Moreover, cosmetic results for the 2-octyl-cyanoacrylate in the adult and children series (without any precise age distinction) seem to be equivalent to conventional sutures. Finally, its application goes with time saving (in preoperative and during wound-healing phase) and increases comfort for patients.
The aim of this study is to evaluate the efficiency of cutaneous use glue Dermabond® (2-octyl-cyanoacrylate) in surgical inguinal incisions sutures in children before the acquisition of continence, by a non-inferiority randomized multicentric prospective study.
Two patient groups will be studied, the sutures of one control group will be made with a conventional technique (intradermic surjet surgical suture), and one patient group will be sutured with 2-octyl-cyanoacrylate. The principal evaluation criteria is the suture quality (short- and long-term cosmetic aspect) evaluated by the surgeon.
Two secondary criteria will be studied :
- Parental satisfaction
- Ease of clinical nursing management Each studied criteria will be evaluated by a numeric score.
- Conditions
- Inguinal Incisions
- Being tested
- cutaneous suture (Surjet), 2-octyl-cyanoacrylate (Dermabond® glue)
- Keywords
- dermabond glue, suture, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cutaneous suture (Surjet)Device
cutaneous surjet suture
2-octyl-cyanoacrylate (Dermabond® glue)Device
Also called 2-octyl-cyanoacrylate (Dermabond®)
the cutaneous suture is made with glue only
| Study group | Role | What they receive |
|---|---|---|
| Cutaneous suture with glue | Experimental | Inguinal surgical incision closing using Dermabond® glue instead of cutaneous suture with surjet Receives: Device: 2-octyl-cyanoacrylate (Dermabond® glue) |
| Conventional suture | Active comparator | Inguinal surgical incision closing with conventional cutaneous suture (surjet) Receives: Device: cutaneous suture (Surjet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate or suboptimal wound-healing rate defined by a HOLLANDER cosmetic score higher or equal to 5 at the end of the initial wound-healing period.
Measured: J7-J10 and J+ 6 month
Secondary outcomes (3)
Re-evaluation of the HOLLANDER cosmetic score 6 month after wound-healing.
Measured: J0, J7-J10 and J + 6 month
Parental satisfaction: 0-100 numeric scale divided in 5 items.
Measured: J0, J7-J10 and J + 6 month
Nurse satisfaction : 0-100 numeric scale divided in 4 items.
Measured: J0, J7-J10 and J + 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal IncisionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Lenval, Centre Hospitalier Régional Universitaire Montpellier, Assistance Publique Hopitaux De Marseille
- Responsible party
- Sponsor
- Investigators
- Jean BREAUD, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909805
- Sponsor's protocol ID
- 08-PP-10
- Status last verified
- Feb 2018
- First submitted
- 28 May 2009
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence. Randomised, Prospective, Non-inferiority Study.
- ClinicalTrials.gov ID
- NCT00909805
- Acronym / sponsor ID
- 08-PP-10
- Conditions
- Inguinal Incisions
- Keywords
- dermabond glue, suture, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Fondation Lenval, Centre Hospitalier Régional Universitaire Montpellier, Assistance Publique Hopitaux De Marseille
- Study start
- Sep 2009 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 29 May 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.
Inguinal incisions are the most frequent incisions used in children before the acquisition of continence (180 incisions per year for the Pediatric Surgery Department in Nice CHU). However, healing of those wounds can be made hard because of soiling induced by urine and/or stool, which is unavoidable in case of wearing nappies.
Nowadays, in order to overcome a possible contamination of the surgical wound, post-surgery wound dressing is protected by the application of a waterproof band aid (like Tegaderm®) during wound-healing (evaluated to a mean of 7 days). When the band aid is soiled, a nurse changes it, causing unpleasantness in low age children (whose epidermal fragility is well known), and sometimes parents worry.
Moreover, those occlusive wound dressings avoid any control of the surgical wound during healing phase.
At the end of the wound-healing time, wound dressings are removed, causing discomfort for children and necessity of a qualified nurse staff at visit times.
Cutaneous use glues, introduced in surgery more than 10 years ago, allow making waterproof and transparent sutures, with a firmness equivalent to a 2/0 string suture (cutaneous suture in children is made with 5/0) and has its own local antiseptic properties. It does not need to be covered by any wound dressing during wound-healing phase. Moreover, cosmetic results for the 2-octyl-cyanoacrylate in the adult and children series (without any precise age distinction) seem to be equivalent to conventional sutures. Finally, its application goes with time saving (in preoperative and during wound-healing phase) and increases comfort for patients.
The aim of this study is to evaluate the efficiency of cutaneous use glue Dermabond® (2-octyl-cyanoacrylate) in surgical inguinal incisions sutures in children before the acquisition of continence, by a non-inferiority randomized multicentric prospective study.
Two patient groups will be studied, the sutures of one control group will be made with a conventional technique (intradermic surjet surgical suture), and one patient group will be sutured with 2-octyl-cyanoacrylate. The principal evaluation criteria is the suture quality (short- and long-term cosmetic aspect) evaluated by the surgeon.
Two secondary criteria will be studied :
- Parental satisfaction
- Ease of clinical nursing management Each studied criteria will be evaluated by a numeric score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cutaneous suture with glue | Experimental | Device: 2-octyl-cyanoacrylate (Dermabond® glue)Inguinal surgical incision closing using Dermabond® glue instead of cutaneous suture with surjet |
| Conventional suture | Active comparator | Device: cutaneous suture (Surjet)Inguinal surgical incision closing with conventional cutaneous suture (surjet) |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children less than 24 months old
- Continuous nappies wearing for non-acquisition of continence
- Need of a surgical intervention which entry way is an inguinal incision in the inguinal fold (POTTS incision) for the following indications:
- Surgical incision smaller than 5 cm
- Informed consent form signed by both parents or by the legal representative
Key exclusion criteria (10 listed)
- Chronic or acute dermatological affection that can hamper wound-healing (atopic pathology, infectious pathology…)
- General affection that can hamper wound-healing (chronic denutrition)
- Cutaneous infection at the incision site
- Scar in the concerned region
- Medical history of wound-healing trouble
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 |
|---|---|---|
| cutaneous suture (Surjet)cutaneous surjet suture | Device | Conventional suture |
| 2-octyl-cyanoacrylate (Dermabond® glue)Also: 2-octyl-cyanoacrylate (Dermabond®)the cutaneous suture is made with glue only | Device | Cutaneous suture with glue |
Primary outcome
Adequate or suboptimal wound-healing rate defined by a HOLLANDER cosmetic score higher or equal to 5 at the end of the initial wound-healing period.
Time frame: J7-J10 and J+ 6 month
3 secondary outcomes
Re-evaluation of the HOLLANDER cosmetic score 6 month after wound-healing.
Time frame: J0, J7-J10 and J + 6 month
Parental satisfaction: 0-100 numeric scale divided in 5 items.
Time frame: J0, J7-J10 and J + 6 month
Nurse satisfaction : 0-100 numeric scale divided in 4 items.
Time frame: J0, J7-J10 and J + 6 month
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 23 Jul 2018.
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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.
Jean BREAUD, MD principal investigator
Centre Hospitalier Universitaire de Nice
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cutaneous suture (Surjet) and 2-octyl-cyanoacrylate (Dermabond® glue) in people with Inguinal Incisions, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
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 10 inclusion and 10 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Adequate or suboptimal wound-healing rate defined by a HOLLANDER cosmetic score higher or equal to 5 at the end of the initial wound-healing period. (time frame: J7-J10 and J+ 6 month). 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 23 Jul 2018.