Clinical trial NCT05490602: Comparison Study in Different Sutures Techniques in Reduction of Known Abdominoplasty Complications and Improving Patients' Post-operative Outcomes
Official title: Comparison Study in Different Sutures Techniques in Reduction of Known Abdominoplasty Complications and Improving Patients' Post-operative Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Abdominoplasty
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women at our department undergoing primary abdominoplasty with transposition of umbilicus with or without liposuction.

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

Adult women at our department undergoing primary abdominoplasty with transposition of umbilicus with or without liposuction

Exclusion Criteria:

* Age \<18 or \>65 years
* History of chemotherapy
* Smoker patient, diabetic patient
* Male patient
* \< 6 months postpartum
* Non-compliant patient

Primary outcomes:
measure: Visual assessment of the wound
timeFrame: 1 year post surgery
measure: Pinch fat of dog ears
timeFrame: 3 months post surgery
measure: Pinch fat of dog ears
timeFrame: 1 year post surgery
measure: Sexual Activity questionnaire
timeFrame: 3 months post surgery
measure: Sexual Activity questionnaire
timeFrame: 1 year post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
References: