Comparison Study in Different Sutures Techniques in Reduction of Known Abdominoplasty Complications and Improving Patients' Post-operative Outcomes

NCT05490602 | Active Not Recruiting

• 1 other identifier: CHUB-Raei Ahmad
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Abdominoplasty

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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)

  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)

  1 year post surgery

Study Arms (2)

Running subcutaneous sutures technique

Abdominoplasty patients will be recruited. 50 patients will undergo the running subcutaneous sutures technique closures.

Procedure: Running subcutaneous sutures technique

Classical closures

Abdominoplasty patients will be recruited. 50 patients will undergo classical closures.

Procedure: Classical closures

Interventions

Running subcutaneous sutures technique PROCEDURE

The Running subcutaneous sutures consist of running sutures in the profound and superficial dermis without knotting the thread (suture).

Running subcutaneous sutures technique

Classical closures PROCEDURE

Classical closures

Classical closures

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of plastic surgery department

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 5, 2022
• Study Start: March 8, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

BE (1)