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

Sponsor
Brugmann University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05490602
Collaborator
(none)
100
1
9.8
10.2

Study Details

Study Description

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 our 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 allowing us to avoid a scar correction surgery and have a better aesthetic outcome. We also evaluate the amelioration of sexual activity after a pubispexy using SAQ(Sexual Activity Questionnaire).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Running subcutaneous sutures technique
  • Procedure: Classical closures

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison Study in Different Sutures Techniques in Reduction of Known Abdominoplasty Complications and Improving Patients' Post-operative Outcomes
Actual Study Start Date :
Mar 8, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Running subcutaneous sutures technique

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

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

Classical closures

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

Procedure: Classical closures
Classical closures

Outcome Measures

Primary Outcome Measures

  1. Visual assessment of the wound [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.

  2. Pinch fat of dog ears [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.

  3. Pinch fat of dog ears [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.

  4. Sexual Activity questionnaire [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.

  5. Sexual Activity questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Brugmann Brussels Belgium 1020

Sponsors and Collaborators

  • Brugmann University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Socorro ORTIZ, Head of plastic surgery department, Brugmann University Hospital
ClinicalTrials.gov Identifier:
NCT05490602
Other Study ID Numbers:
  • CHUB-Raei Ahmad
First Posted:
Aug 5, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 5, 2022