Drainage Techniques for Postoperative Complications
Recruiting in Palo Alto (17 mi)
Overseen ByBen Mueller, MD, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Twin Cities Spine Center
Must not be taking: Anticoagulants
Disqualifiers: Infection, Tumor, Trauma, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on blood thinners (anticoagulation treatment), you may not be eligible to participate.
What data supports the effectiveness of the treatment Drain for postoperative complications?
Research shows that using drainage systems can help manage postoperative fluid collection and prevent complications like infections. For example, a study found that a modified drainage technique was feasible and safe for removing fluid in hard-to-reach areas after surgery.
12345Is drainage generally safe for humans in clinical settings?
Some studies suggest that the use of drains can lead to complications, such as infections, especially in certain surgeries like laparotomy in neonates and colorectal surgery. However, softer and more flexible drains may cause fewer problems than rigid ones.
678910How does the Drain treatment differ from other treatments for postoperative complications?
The Drain treatment is unique because it involves using softer and more pliable drains, which may cause less harm compared to stiffer, more rigid drains. Additionally, a modified surgical drain-guided technique can be used to safely and effectively manage fluid collections in hard-to-reach areas after surgery.
145911Eligibility Criteria
This trial is for individuals undergoing one or two-level open spinal decompression or fusion to treat lumbar stenosis/spondylolisthesis. It's not for those with more than two levels of lumbar fusion, anterior surgery, CSF leaks, infections, tumors, trauma history, perioperative anticoagulation treatment, incidental durotomy during surgery, prior lumbar fusion or significant blood loss during operation.Inclusion Criteria
I had surgery for lower back issues caused by narrowed spaces or slipped discs.
Exclusion Criteria
My surgery involved an accidental tear in the spinal cord covering.
I have had lumbar fusion surgery on more than 2 levels.
I have had surgery on the front part of my lower spine.
I have had a leak of fluid around my brain after surgery.
I have had surgery to fuse bones in my lower back.
I am on blood thinners around the time of my surgery.
I lost more than one liter of blood during surgery.
Participant Groups
The study aims to determine if using a drain after spinal decompression/fusion surgeries can reduce postoperative complications like infection or the need for additional surgeries. Participants will be randomly assigned to receive either the drainage technique being studied or no drain.
3Treatment groups
Experimental Treatment
Active Control
Group I: Passive DrainExperimental Treatment1 Intervention
The drain will be used with gravity alone.
Group II: Active DrainExperimental Treatment1 Intervention
The drain will be used with compression suction.
Group III: No DrainActive Control1 Intervention
No drain will be used.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Abbott Northwestern HospitalMinneapolis, MN
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Who is running the clinical trial?
Twin Cities Spine CenterLead Sponsor
Allina Health SystemCollaborator
References
Predictive factors for failure of percutaneous drainage of postoperative abscess after abdominal surgery. [2016]The aims of this study were to assess the efficacy of percutaneous drainage of postoperative abscess after abdominal surgery and to identify factors predictive of failed drainage.
Early experience with the Thopaz+ chest drainage system - is this a new era in the management of post-cardiotomy bleeding? [2022]Monitoring postoperative drainage is a key aspect of patient assessment in the early postoperative period. Accurate assessment of drainage allows rapid diagnosis of postoperative bleeding, preventing excessive hemoglobin drop and cardiac tamponade. However, traditional methods of mediastinal drainage appear to be inaccurate and measurement can often be subjective, delaying the procedure.
Procrastination of wound drainage and malnutrition affect the outcome of joint arthroplasty. [2022]The association between wound drainage and subsequent periprosthetic infection is well known. However, the most appropriate treatment of wound drainage is not well understood. We retrospectively reviewed the records of 10,325 patients (11,785 procedures), among whom 300 patients (2.9%) developed persistent (greater than 48 hours postoperatively) wound drainage. Wound drainage stopped spontaneously between 2 and 4 days in 217 patients treated with local wound care and oral antibiotics. The remaining 83 patients (28%) underwent further surgery. A single débridement resulted in cessation of drainage without subsequent infection in 63 of 83 patients (76%), whereas 20 (24%) patients continued to drain and underwent additional treatment (repeat débridement, resection arthroplasty, or long-term antibiotics). Timing of surgery and the presence of malnutrition predicted failure of the first débridement. There were no differences between the success and failure groups with regard to all other examined parameters, including demographic or surgical factors.
Incidence of postoperative complications in patients with breast cancer depending on the type of drain. [2023]Postoperative complications in patients with breast cancer delay the initiation of adjuvant therapy, prolong the length of hospitalization and reduce the patients' quality of life. Although their incidence can be influenced by many factors, the connection with the type of drain is insufficiently studied in the literature. The aim of this study was to assess whether there is an association between the use of a different drainage system and the occurrence of postoperative complications.
Modified Surgical Drain-Guided Percutaneous Catheter Drainage of Postoperative Fluid Collection in Inaccessible Locations. [2023]To investigate the feasibility and safety of a modified surgical drain-guided percutaneous catheter drainage technique for postoperative fluid collection in inaccessible locations.
Safety of early pelvic drain removal in colorectal surgery based on drainage quantity. [2023]This study aimed to investigate the association between the drainage quantity of pelvic drains and postoperative complications in colorectal surgery.
A prospective comparative study of routine versus deferred pelvic drain placement after radical prostatectomy: impact on complications and opioid use. [2021]To evaluate the association of post-RP drain placement with post-operative complications and opioid use at a high-volume institution.
Placement of prophylactic drains after laparotomy may increase infectious complications in neonates. [2021]The aim of this study was to determine if the placement of prophylactic drains influences the incidence of postoperative adverse events in neonates.
Observations on wound drainage with a review of the literature. [2021]Observations have been made on the choice of wound drainage in 119 general surgical or urological procedures performed by surgeons in a general hospital. Complications of the drains used are reported. Softer and more pliable drains appear to cause less morbidity than the stiffer, more rigid variety. The literature dealing with drainage is reviewed.
Subcutaneous suction drains do not prevent surgical site infections in clean-contaminated abdominal surgery-results of a systematic review and meta-analysis. [2020]The role of subcutaneous prophylactic drainage in preventing postoperative abdominal wound complications is still controversial. We aimed to elucidate whether any difference in the incidence of surgical site infection (SSI) exists between patients with or without subcutaneous suction drain following clean-contaminated abdominal surgery.
Evaluation of the potential complications of surgical wound drainage in primary total hip arthroplasty: a prospective controlled double-blind study. [2022]The routine use of postoperative wound drainage following total hip arthroplasty (THA) to avoid the creation of excessive haematomas is controversial because of the potential risk of blood loss and wound infection.