AbdominoplastyNCT05490602
Comparison Study in Different Sutures Techniques in Reduction of Known Abdominoplasty Complications and Improving Patients' Post-operative Outcomes
An observational study of Abdominoplasty, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
After an important weight loss abdominoplasty has become one of the most frequent interventions to remove excess skin to achieve the best cosmetic and body perception psychological results after weight loss. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abdominoplasty
- What is being tested?
- Running subcutaneous sutures technique and Classical closures
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Mar 2022to 31 Dec 2024
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women at our department undergoing primary abdominoplasty with transposition of umbilicus with or without liposuction.
Who may be able to join
- Adult women at our department undergoing primary abdominoplasty with transposition of umbilicus with or without liposuction
Who cannot join
- Age <18 or >65 years
- History of chemotherapy
- Smoker patient, diabetic patient
- Male patient
- < 6 months postpartum
- Non-compliant patient
Trial locations and contacts
1 site in 1 country.
About this study
After an important weight loss abdominoplasty has become one of the most frequent interventions to remove excess skin to achieve the best cosmetic and body perception psychological results after weight loss. The American Society of Plastic surgeons have published documents in 2004 indicating a 344% increase in the number of abdominoplasty cases.
Dog ears is one of the classical complications in body contouring and abdominoplasty which needs a scar revision to achieve the optimum cosmetic result. It's due to bad tension from the closed scar.
Read more
In a classical abdominoplasty wound closure subcuticular, (or intradermal) sutures can be interrupted or placed in a running fashion. Such a technique obviates the need for external skin sutures and circumvents the possibility of suture marks in the skin. Other techniques have been described in the literature to reduce abdominoplasty complication (seroma, hematoma, infection, dog ear, flap necrosis etc.. ) such as classical high lateral tension and lipo-aspiration on preventing dog ears and elongation scar was evaluated and progressive tension sutures. The running subcutaneous sutures that consist of running sutures in the profound and superficial dermis without knotting the thread(suture) showed less dog ears occurrence and other complications which leads to more patient satisfaction and less scar revision. Dog ear is referred to as a puckering of the skin that appears sometimes at the end of a scar, especially after procedures that involve some degree of skin tightening or when skin after the end of the scar is looser than skin along the scar itself creating a small excess of skin where the incision ends.
So far there's no reported epidemiology for dog ears in the literature, however it's mentioned in some papers where it's a common complication and reason for scar revision in abdominoplasty and breast reduction surgery.
The aim of this study is to compare the incidence of dog ear and other complications in classical abdominoplasty closure to running subcutaneous sutures, method, which decreases dog ear incidence, wound dehiscence, infection and hypertrophic scar which are actually quite common after abdominoplasty. This allows to avoid a scar correction surgery and have a better aesthetic outcome. The investigators also evaluate the amelioration of sexual activity after a pubis-pexy using SAQ(Sexual Activity Questionnaire).
- Conditions
- Abdominoplasty
- Being tested
- Running subcutaneous sutures technique, Classical closures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running subcutaneous sutures techniqueProcedure or surgery
The Running subcutaneous sutures consist of running sutures in the profound and superficial dermis without knotting the thread (suture).
Classical closuresProcedure or surgery
Classical closures
| Study group | Role | What they receive |
|---|---|---|
| Running subcutaneous sutures technique | Abdominoplasty patients will be recruited. 50 patients will undergo the running subcutaneous sutures technique closures. Receives: Procedure: Running subcutaneous sutures technique | |
| Classical closures | Abdominoplasty patients will be recruited. 50 patients will undergo classical closures. Receives: Procedure: Classical closures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment of the wound
Pre-operative and post-operative photography will be taken in both groups allowing a visual assessment of the result. The end results will be examined by a third blinded party without a previous knowledge of which technique was used.
Measured: 1 year post surgery
Pinch fat of dog ears
Absence/presence of dog ears. Dog ears is one of the classical complications in body contouring and abdominoplasty which needs a scar revision to achieve the optimum cosmetic result. It's due to bad tension from the closed scar.
Measured: 3 months post surgery
Pinch fat of dog ears
Absence/presence of dog ears. Dog ears is one of the classical complications in body contouring and abdominoplasty which needs a scar revision to achieve the optimum cosmetic result. It's due to bad tension from the closed scar.
Measured: 1 year post surgery
Sexual Activity questionnaire
The sexual activity questionnaire is a 20-item tool that is focused on the relational, emotional, and behavioral aspects of sexual activity in the general population. Each question is rated using a four-point Likert scale from 0 to 3 (0 : not at all, and 3 : very much)
Measured: 3 months post surgery
Sexual Activity questionnaire
The sexual activity questionnaire is a 20-item tool that is focused on the relational, emotional, and behavioral aspects of sexual activity in the general population. Each question is rated using a four-point Likert scale from 0 to 3 (0 : not at all, and 3 : very much)
Measured: 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start8 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Socorro ORTIZ, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490602
- Sponsor's protocol ID
- CHUB-Raei Ahmad
- Status last verified
- Feb 2024
- First submitted
- 4 Aug 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study in Different Sutures Techniques in Reduction of Known Abdominoplasty Complications and Improving Patients' Post-operative Outcomes
- ClinicalTrials.gov ID
- NCT05490602
- Acronym / sponsor ID
- CHUB-Raei Ahmad
- Conditions
- Abdominoplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Aug 2022 (actual)
- 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.
After an important weight loss abdominoplasty has become one of the most frequent interventions to remove excess skin to achieve the best cosmetic and body perception psychological results after weight loss. The American Society of Plastic surgeons have published documents in 2004 indicating a 344% increase in the number of abdominoplasty cases.
Dog ears is one of the classical complications in body contouring and abdominoplasty which needs a scar revision to achieve the optimum cosmetic result. It's due to bad tension from the closed scar.
In a classical abdominoplasty wound closure subcuticular, (or intradermal) sutures can be interrupted or placed in a running fashion. Such a technique obviates the need for external skin sutures and circumvents the possibility of suture marks in the skin. Other techniques have been described in the literature to reduce abdominoplasty complication (seroma, hematoma, infection, dog ear, flap necrosis etc.. ) such as classical high lateral tension and lipo-aspiration on preventing dog ears and elongation scar was evaluated and progressive tension sutures. The running subcutaneous sutures that consist of running sutures in the profound and superficial dermis without knotting the thread(suture) showed less dog ears occurrence and other complications which leads to more patient satisfaction and less scar revision. Dog ear is referred to as a puckering of the skin that appears sometimes at the end of a scar, especially after procedures that involve some degree of skin tightening or when skin after the end of the scar is looser than skin along the scar itself creating a small excess of skin where the incision ends.
So far there's no reported epidemiology for dog ears in the literature, however it's mentioned in some papers where it's a common complication and reason for scar revision in abdominoplasty and breast reduction surgery.
The aim of this study is to compare the incidence of dog ear and other complications in classical abdominoplasty closure to running subcutaneous sutures, method, which decreases dog ear incidence, wound dehiscence, infection and hypertrophic scar which are actually quite common after abdominoplasty. This allows to avoid a scar correction surgery and have a better aesthetic outcome. The investigators also evaluate the amelioration of sexual activity after a pubis-pexy using SAQ(Sexual Activity Questionnaire).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Running subcutaneous sutures technique | – | Procedure: Running subcutaneous sutures techniqueAbdominoplasty patients will be recruited. 50 patients will undergo the running subcutaneous sutures technique closures. |
| Classical closures | – | Procedure: Classical closuresAbdominoplasty patients will be recruited. 50 patients will undergo classical closures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women at our department undergoing primary abdominoplasty with transposition of umbilicus with or without liposuction.
Key inclusion criteria (1 listed)
- Adult women at our department undergoing primary abdominoplasty with transposition of umbilicus with or without liposuction
Key exclusion criteria (6 listed)
- Age <18 or >65 years
- History of chemotherapy
- Smoker patient, diabetic patient
- Male patient
- < 6 months postpartum
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 |
|---|---|---|
| Running subcutaneous sutures techniqueThe Running subcutaneous sutures consist of running sutures in the profound and superficial dermis without knotting the thread (suture). | Procedure or surgery | Running subcutaneous sutures technique |
| Classical closuresClassical closures | Procedure or surgery | Classical closures |
Primary outcome
Visual assessment of the wound
Time frame: 1 year post surgery
Pre-operative and post-operative photography will be taken in both groups allowing a visual assessment of the result. The end results will be examined by a third blinded party without a previous knowledge of which technique was used.
Pinch fat of dog ears
Time frame: 3 months post surgery
Absence/presence of dog ears. Dog ears is one of the classical complications in body contouring and abdominoplasty which needs a scar revision to achieve the optimum cosmetic result. It's due to bad tension from the closed scar.
Pinch fat of dog ears
Time frame: 1 year post surgery
Absence/presence of dog ears. Dog ears is one of the classical complications in body contouring and abdominoplasty which needs a scar revision to achieve the optimum cosmetic result. It's due to bad tension from the closed scar.
Sexual Activity questionnaire
Time frame: 3 months post surgery
The sexual activity questionnaire is a 20-item tool that is focused on the relational, emotional, and behavioral aspects of sexual activity in the general population. Each question is rated using a four-point Likert scale from 0 to 3 (0 : not at all, and 3 : very much)
Sexual Activity questionnaire
Time frame: 1 year post surgery
The sexual activity questionnaire is a 20-item tool that is focused on the relational, emotional, and behavioral aspects of sexual activity in the general population. Each question is rated using a four-point Likert scale from 0 to 3 (0 : not at all, and 3 : very much)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominoplasty, run by Brugmann University Hospital at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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 Belgium. 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?
Results are not available in the source record.
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?
Visual assessment of the wound (time frame: 1 year post surgery). The study lists 5 primary outcomes in all. 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 7 Feb 2024.