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| Name | Class |
|---|---|
| Fondation Hôpital Saint-Joseph | OTHER |
The goal of this study is to assess whether running deep wound stiches will be superior to deep interrupted stiches in body contouring surgeries in massive weight loss patients. This is a split-wound study, thereby providing an internal control within each wound. Each side of the wound will be randomized to receive one of the two suturing techniques. Patients and raters will be blinded to the suture technique used in both wound-halfs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Running sutures | Active Comparator | Deep layers will be closed using running sutures |
|
| Interrupted sutures | Experimental | Deep layers will be closed using interrupted sutures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Running sutures | Other |
| ||
| Interrupted sutures |
| Measure | Description | Time Frame |
|---|---|---|
| Scar cosmesis | The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars. | 15 days |
| Scar cosmesis | The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars. | 1.5 months |
| Scar cosmesis | The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars. | 3 months |
| Scar cosmesis | The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Scar Width | The width of the scar will be measured 10 centimeter from the midline on both scar-halfs. | 3 months |
| Measurement of Scar Width | The width of the scar will be measured 10 centimeter from the midline on both scar-halfs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Josph Hospital | Recruiting | Paris | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 6 months |
| Adverse Events | Noting the presence or absence of dehiscence, infection or spitting sutures. | 15 days |
| Adverse Events | Noting the presence or absence of dehiscence, infection or spitting sutures. | 1.5 months |
| Adverse Events | Noting the presence or absence of dehiscence, infection or spitting sutures. | 3 months |
| Adverse Events | Noting the presence or absence of dehiscence, infection or spitting sutures. | 6 months |
| Time spent suturing the wound | The time spent suturing each half of the scar will be recorded in minutes | up to 24h |
| Number of suture thread needed | The number of threads used to suture each half of the scar will be recorded | up to 24h |