Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.
The purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. Patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the Dermabond Prineo skin adhesive system versus standard subcuticular suture. Dermabond Prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. In addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermabond Prineo Group | Active Comparator | At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system. |
|
| Suture Group | Placebo Comparator | At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermabond Prineo | Device | For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Scar Satisfaction Scale Score | The patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction. | Assessed at 6-weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surgical Site Infection (SSI) | A composite of surgical site infection (SSI) will be assessed. This composite will include superficial and deep SSI, endometritis, wound separation from any cause, and/or fascial dehiscence. | Assessed during delivery hospitalization and at 6-week follow-up |
| Skin Closure Time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Russell Miller, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center/NYP | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32271475 | Background | Goto S, Sakamoto T, Ganeko R, Hida K, Furukawa TA, Sakai Y. Subcuticular sutures for skin closure in non-obstetric surgery. Cochrane Database Syst Rev. 2020 Apr 9;4(4):CD012124. doi: 10.1002/14651858.CD012124.pub2. | |
| 25431843 | Background | Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJ. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD004287. doi: 10.1002/14651858.CD004287.pub4. |
| Label | URL |
|---|---|
| Dermabond Prineo | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dermabond Prineo Group | At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system. Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines. |
| FG001 | Suture Group | At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture. Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dermabond Prineo Group | At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system. Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Scar Satisfaction Scale Score | The patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction. | Posted | Median | Inter-Quartile Range | score on a scale | Assessed at 6-weeks postpartum |
|
Up to 6 weeks post-surgery
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dermabond Prineo Group | At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system. Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged Hospitalization | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical site complication | Surgical and medical procedures | Non-systematic Assessment | Surgical site infection or complication for delivery |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russell Miller, MD | Columbia University | 212-305-6293 | rsm20@cumc.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2024 | Jan 13, 2026 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006406 | Hematoma |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Women undergoing cesarean delivery will be recruited and randomized to skin closure with either the Dermabond Prineo system or standard subcuticular suture.
Not provided
Not provided
Not provided
Not provided
| Suture | Other | For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method. |
|
The skin closure time will be assessed. |
| Intraoperative |
| Operative Time | The total operative time will be assessed. | Intraoperative |
| 16079683 | Background | van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6. |
| 29739243 | Background | Fleisher J, Khalifeh A, Pettker C, Berghella V, Dabbish N, Mackeen AD. Patient satisfaction and cosmetic outcome in a randomized study of cesarean skin closure. J Matern Fetal Neonatal Med. 2019 Nov;32(22):3830-3835. doi: 10.1080/14767058.2018.1474870. Epub 2018 May 24. |
| BG001 |
| Suture Group |
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture. Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Suture Group |
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture. Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method. |
|
|
| Secondary | Incidence of Surgical Site Infection (SSI) | A composite of surgical site infection (SSI) will be assessed. This composite will include superficial and deep SSI, endometritis, wound separation from any cause, and/or fascial dehiscence. | Posted | Number | surgical site infections | Assessed during delivery hospitalization and at 6-week follow-up |
|
|
|
| Secondary | Skin Closure Time | The skin closure time will be assessed. | Posted | Mean | Inter-Quartile Range | minutes | Intraoperative |
|
|
|
| Secondary | Operative Time | The total operative time will be assessed. | Posted | Mean | Inter-Quartile Range | minutes | Intraoperative |
|
|
|
| 0 |
| 73 |
| 5 |
| 73 |
| 9 |
| 73 |
| EG001 | Suture Group | At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture. Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method. | 0 | 78 | 11 | 78 | 8 | 78 |
| Readmission or presentation to ED | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
|
Not provided
Not provided
Not provided