Obesity Clinical Trial
— CAPSOfficial title:
Evaluation of ciNPT Effects on Healing and Post-surgical Complications in High-risk Post- Bariatric Patients Undergoing Body-contouring Abdominoplasty: a Monocentric Prospective RCT
The overarching goal of this research is to assess whether the post-operative use of
closed-incision Negative Pressure Therapy (ciNPT) accelerates healing of surgical wounds,
improves surgical outcomes, and reduces the rate of local complications in high-risk, obese,
post-bariatric patients undergoing abdominal body-contouring procedures (abdominal
panniculectomy or "abdominoplasty") compared to standard wound care.
The investigators postulate that ciNPT can cost-effectively improve outcomes and standard of
post-surgical care in this specific category of patients.
This hypothesis will be tested through a prospective, interventional, case-control,
randomized clinical trial.
Status | Not yet recruiting |
Enrollment | 130 |
Est. completion date | January 31, 2023 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - previous bariatric surgery for weight loss - candidate for/undergoing an abdominal panniculectomy (abdominoplasty) - Residual BMI >30 kg/m2 at the time of the operation - Evidence of pannus (abdominal) ptosis (Pittsburgh Rating Scale >2) - Lipodystrophy and inelasticity of the skin - Presence at the time of surgery of at least one local risk factor (e.g. a history or the presence of local complications such as skin blistering, recurrent erythema, panniculitis, or chronic infection; history of abdominal hernia or need for abdominal hernia repair) OR one systemic risk factor (diabetes, smoking habit, serum proteins below 6g/dL). Exclusion Criteria: - Severe systemic co-morbidities (defined as ASA III or higher) - Malignant tumors - Conditions or medications affecting wound healing (e.g. steroidal drugs or keloids) - Known allergies to components of the treatment - Presence of severe local cutaneous complications (open wounds, extensive infections) at the time of surgery. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera, Ospedale Civile di Legnano | Acelity |
Abatangelo S, Saporiti E, Giatsidis G. Closed Incision Negative-Pressure Therapy (ciNPT) Reduces Minor Local Complications in Post-bariatric Abdominoplasty Body Contouring: a Retrospective Case-Control Series. Obes Surg. 2018 Jul;28(7):2096-2104. doi: 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of post-surgical local complications | The change in post-surgical local complications (Skin blistering/necrosis, Surgical Site Infections, hematoma, seroma, need for re-operation) through 30 days after surgery. | 30 days | |
Secondary | Time-to-heal | A change in time (days) to complete wound closure for treated groups vs. controls. | <60 days | |
Secondary | Scar quality: Vancouver Scar Scale | A change in the macroscopic quality of scars at a 30 and 90 days follow up (measured with the Vancouver Scar Scale-VSS [Score range: 0-13, lower scores being a better outcome]). | 30 and 90 days | |
Secondary | Medical costs | A change in direct medical costs (considering cumulative costs related to: hospitalization, standard and additional post-operative care, additional surgical and medical care for complications) in the first 60 days after surgery. | 60 days |
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