Researchers at The University of Texas Health Science Center at Houston (UTHealth) plan to launch a clinical study looking at complication rates in patients who have experienced severe trauma to the abdominal area and require immediate surgery to diagnose and treat the injuries at Memorial Hermann-Texas Medical Center.
The principal investigator is John Harvin, M.D., who is an assistant professor of surgery with John P. and Kathrine G. McGovern Medical School at UTHealth and is affiliated with the Memorial Hermann Texas Trauma Institute.
This study will involve a group of patients who require an immediate abdominal laparotomy and physicians do not have definitive guidelines to close or leave open. Harvin and group will closely monitor the patients while they are in the hospital and will contact them at six months to check on their recovery progress. The purpose of the study is to see if there are more complications in the group of patients who have their incision left open after the first surgery.
The trauma surgeon performing the surgery will determine if the patient is a good candidate to be enrolled in the study. This study will require the physicians to begin this research without first obtaining an informed consent of the patient or the legal representative and/or family member. All reasonable attempts will be made to contact a family member to discuss this study and obtain their permission for the patient to be enrolled in the study. All studies are voluntary and the patient and/or family members can decide at any time to withdraw from the study.
Harvin and members of the UTHealth research team will present the project and field questions at a series of meetings with community groups depicted as representatives of the city of Houston, Harris County, and surrounding cities and counties. A member of the Committee for the Protection of Human Subjects (CPHS) will also attend the meetings to assist in answering questions related to emergency consent issues, etc. Upon completion of the community consultation meetings, Harvin's team will report back to the CPHS, which will determine whether UTHealth will participate in this clinical study at Memorial Hermann-Texas Medical Center.
If you would like to schedule a community consultation meeting or would like more information, please visit go.uth.edu/dcltrial or contact Harvin at 713-500-6407.