Laparotomy Clinical Trial
Official title:
DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery
NCT number | NCT03966768 |
Other study ID # | 0001 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 15, 2023 |
Est. completion date | December 31, 2025 |
Verified date | September 2022 |
Source | Mesh Suture Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multisite randomized control proof-of-concept trial to evaluate the safety of Duramesh laparotomy closure in the trauma and emergency laparotomy setting. The study will be performed at University of Maryland Shock Trauma Center and Walter Reed National Military Medical Center. One hundred (100) patients will be randomized (2:1) to Duramesh laparotomy closure versus conventional suture closure. After the patient has been confirmed to be a candidate for the trial, randomization will be performed in the operating room upon completion of the index abdominal procedure. Duramesh will be provided for patients assigned to the Duramesh treatment arm. Patients will be followed for 1 year following laparotomy closure at follow-up intervals of 1 month, 3 months, 6 months, and 12 months.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Midline laparotomy greater than 5 cm in length - Urgent or emergent surgery following trauma - Urgent or emergent surgery for diverticulitis - Large or small bowel obstruction, acute abdomen, or intra-abdominal hemorrhage. - Open abdomen after midline laparotomy. Exclusion Criteria: - Prior hernia repair or existing abdominal mesh - Metastatic cancer - Pregnancy - Immunosuppression. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mesh Suture Inc. | Uniformed Services University of the Health Sciences, University of Maryland, Walter Reed National Military Medical Center |
Dumanian GA, Lanier ST, Souza JM, Young MW, Mlodinow AS, Boller AM, Mueller KH, Halverson AL, McGee MF, Stulberg JJ. Mesh sutured repairs of contaminated incisional hernias. Am J Surg. 2018 Aug;216(2):267-273. doi: 10.1016/j.amjsurg.2017.10.025. Epub 2017 Oct 25. — View Citation
Dumanian GA, Tulaimat A, Dumanian ZP. Experimental study of the characteristics of a novel mesh suture. Br J Surg. 2015 Sep;102(10):1285-92. doi: 10.1002/bjs.9853. Epub 2015 Jul 8. — View Citation
Lanier ST, Dumanian GA, Jordan SW, Miller KR, Ali NA, Stock SR. Mesh Sutured Repairs of Abdominal Wall Defects. Plast Reconstr Surg Glob Open. 2016 Sep 28;4(9):e1060. eCollection 2016 Sep. — View Citation
Souza JM, Dumanian ZP, Gurjala AN, Dumanian GA. In vivo evaluation of a novel mesh suture design for abdominal wall closure. Plast Reconstr Surg. 2015 Feb;135(2):322e-330e. doi: 10.1097/PRS.0000000000000910. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical site infection | Superficial or deep infection of the surgical site | 1 month | |
Primary | Surgical site infection | Superficial or deep infection of the surgical site | 3 months | |
Primary | Surgical site infection | Superficial or deep infection of the surgical site | 6 months | |
Primary | Surgical site infection | Superficial or deep infection of the surgical site | 12 months | |
Secondary | Surgical site occurrence | Any complication related to the surgical site, including hematoma, seroma, dehiscence, fistula, small bowel obstruction, exposed suture, return to the operating room, readmission, or mortality | 1 month | |
Secondary | Surgical site occurrence | Any complication related to the surgical site, including hematoma, seroma, dehiscence, fistula, small bowel obstruction, exposed suture, return to the operating room, readmission, or mortality | 3 months | |
Secondary | Surgical site occurrence | Any complication related to the surgical site, including hematoma, seroma, dehiscence, fistula, small bowel obstruction, exposed suture, return to the operating room, readmission, or mortality | 6 months | |
Secondary | Surgical site occurrence | Any complication related to the surgical site, including hematoma, seroma, dehiscence, fistula, small bowel obstruction, exposed suture, return to the operating room, readmission, or mortality | 12 months | |
Secondary | Intraoperative and hospitalization endpoints | Details regarding abdominal wall closure | Within 30 days | |
Secondary | Intraoperative and hospitalization endpoints | Length of hospital stay | Within 30 days | |
Secondary | Intraoperative and hospitalization endpoints | Length of the laparotomy incision and length of suture remnant | Within 30 days | |
Secondary | Intraoperative and hospitalization endpoints | Size of Duramesh used | Within 30 days | |
Secondary | Hernia formation | Clinical development of an incisional hernia | anytime within 12 months | |
Secondary | Patient reported outcomes | NRS pain scale | 3 months | |
Secondary | Patient reported outcomes | NRS pain scale | 6 months | |
Secondary | Patient reported outcomes | HerQles | 6 months | |
Secondary | Patient reported outcomes | SF-36 | 6 months | |
Secondary | Patient reported outcomes | HerQles | 12 months | |
Secondary | Patient reported outcomes | SF-36 | 12 months | |
Secondary | Patient reported outcomes | NRS pain scale | 12 months |
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