Drainage Techniques for Postoperative Complications

Overseen By John M Dawson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Twin Cities Spine Center

Must not be taking: Anticoagulants

Disqualifiers: Infection, Tumor, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

975 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{1 4 5 9 11}

Research Team

Ben Mueller, MD, PhD

Principal Investigator

Twin Cities Spine Center

Eligibility 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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Postoperative Care

Participants undergo one- or two-level open posterior lumbar decompression or decompression and fusion surgery, followed by immediate postoperative care including the use of drainage techniques

1 week

Postoperative Monitoring

Participants are monitored for complications, drain removal, and other postoperative outcomes

12 weeks

Regular follow-up visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Drain

Trial Overview 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.

Participant Groups

Group I: Passive Drain Experimental Treatment 1 Intervention

The drain will be used with gravity alone.

Group II: Active Drain Experimental Treatment 1 Intervention

The drain will be used with compression suction.

Group III: No Drain Active Control 1 Intervention

No drain will be used.

Who Is Running the Clinical Trial?

Twin Cities Spine Center

Lead Sponsor

Trials

4

Recruited

1,300+

Allina Health System

Collaborator

Trials

60

Recruited

1,178,000+

Findings from Research

Percutaneous drainage of postoperative abdominopelvic abscesses is an effective treatment method, achieving a success rate of 78% in a study of 81 patients.

The presence of residual collection after the first drainage procedure is a significant predictor of treatment failure, indicating that careful monitoring is essential for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors for failure of percutaneous drainage of postoperative abscess after abdominal surgery. Kassi, F., Dohan, A., Soyer, P., et al.[2016]

The Thopaz+ digital chest drainage system was used in 42 cardiac surgery patients, allowing for accurate monitoring of postoperative drainage without complications, which enhances patient safety.

This system facilitates early patient rehabilitation and provides a more objective assessment of drainage compared to traditional methods, leading to quicker therapeutic decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early experience with the Thopaz+ chest drainage system - is this a new era in the management of post-cardiotomy bleeding? Pawelkowska, K., Bartus, S., Sobczynski, R., et al.[2022]

In a study of 10,325 patients, 2.9% experienced persistent wound drainage after surgery, with most cases resolving spontaneously or through local care and oral antibiotics.

For patients requiring surgical intervention, a single débridement was effective in stopping drainage in 76% of cases, highlighting its efficacy, although factors like timing of surgery and malnutrition were linked to higher failure rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procrastination of wound drainage and malnutrition affect the outcome of joint arthroplasty. Jaberi, FM., Parvizi, J., Haytmanek, CT., et al.[2022]

In a study of 183 breast cancer patients, the use of a capillary drain resulted in a significantly lower incidence of postoperative hematomas (10.34%) compared to a Redon drain (22.92%).

Both types of drains showed similar rates of seroma formation (39.6% for Redon vs. 35.6% for capillary), and there were no significant differences in drainage time or total wound drainage amount.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of postoperative complications in patients with breast cancer depending on the type of drain. Procházka, V., Závadová, A., Žatecký, J., et al.[2023]

The modified surgical drain-guided percutaneous catheter drainage technique was successfully used in 24 patients with a high technical success rate of 91.7% and a clinical success rate of 90.9%, demonstrating its efficacy in draining fluid collections in difficult-to-access locations.

No adverse events were reported within 30 days of the procedure, indicating that this technique is safe for patients who cannot undergo conventional drainage methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Surgical Drain-Guided Percutaneous Catheter Drainage of Postoperative Fluid Collection in Inaccessible Locations. Lee, HN., Hyun, D., Lee, WH., et al.[2023]

In a study of 122 colorectal surgery patients, it was found that the quantity of drainage from pelvic drains decreases shortly after surgery, regardless of whether complications arise, suggesting that early drain removal may be safe and beneficial.

The study indicated that drainage quantity is not a reliable indicator for diagnosing or treating organ-space surgical site infections, as only a small number of patients showed changes in drainage quality related to infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of early pelvic drain removal in colorectal surgery based on drainage quantity. Yoshimura, K., Ohge, H., Watadani, Y., et al.[2023]

In a study of 498 patients undergoing robot-assisted or open radical prostatectomy (RP), routine placement of pelvic drains did not lead to a reduction in post-operative complications or opioid use, indicating that drains may not be necessary for all patients.

Experienced surgeons can safely defer drain placement in most robot-assisted RP cases without increasing the risk of adverse events or complications, suggesting a potential for improved patient comfort and reduced recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective comparative study of routine versus deferred pelvic drain placement after radical prostatectomy: impact on complications and opioid use. Huang, MM., Patel, HD., Su, ZT., et al.[2021]

In a study of neonates undergoing laparotomy, the use of prophylactic drains did not significantly reduce overall postoperative complications compared to a non-drainage approach, with complication rates of 48% for the drainage group and 36% for the non-drainage group.

Interestingly, in cases involving upper gastrointestinal tract operations, the drainage group experienced significantly higher rates of total postoperative complications and infectious complications, suggesting that the use of drains may actually increase the risk of infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placement of prophylactic drains after laparotomy may increase infectious complications in neonates. Inoue, M., Uchida, K., Otake, K., et al.[2021]

In a study of 119 surgical procedures, it was observed that softer and more pliable wound drains resulted in fewer complications compared to stiffer, rigid drains.

The findings suggest that the choice of drain material can significantly impact patient outcomes, highlighting the importance of selecting appropriate drainage methods in surgical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observations on wound drainage with a review of the literature. Golovsky, D., Conolly, WB.[2021]

A meta-analysis of 8 studies involving 2833 patients found no significant difference in the incidence of surgical site infections (SSI) between patients who had subcutaneous suction drains and those who did not after clean-contaminated abdominal surgery.

The results suggest that routine use of subcutaneous drains is not recommended for preventing postoperative wound infections, although there may be specific patient groups that could still benefit from their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous suction drains do not prevent surgical site infections in clean-contaminated abdominal surgery-results of a systematic review and meta-analysis. Coletta, D., Del Basso, C., Giuliani, G., et al.[2020]

In a study of 1162 patients undergoing total hip arthroplasty, those with negative pressure wound drainage experienced a significantly greater drop in blood hemoglobin and hematocrit levels, leading to a higher need for blood transfusions compared to those without drainage.

Despite lower pain levels on the first day post-surgery in the drainage group, overall functional outcomes and infection rates were similar between both groups, suggesting that the use of drainage may not provide significant benefits and could increase transfusion requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the potential complications of surgical wound drainage in primary total hip arthroplasty: a prospective controlled double-blind study. Lychagin, AV., Rosenberg, N., Gritsyuk, AA.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictive factors for failure of percutaneous drainage of postoperative abscess after abdominal surgery. [2016]

2. Poland pubmed.ncbi.nlm.nih.gov

Early experience with the Thopaz+ chest drainage system - is this a new era in the management of post-cardiotomy bleeding? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Procrastination of wound drainage and malnutrition affect the outcome of joint arthroplasty. [2022]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

Incidence of postoperative complications in patients with breast cancer depending on the type of drain. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Modified Surgical Drain-Guided Percutaneous Catheter Drainage of Postoperative Fluid Collection in Inaccessible Locations. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety of early pelvic drain removal in colorectal surgery based on drainage quantity. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

A prospective comparative study of routine versus deferred pelvic drain placement after radical prostatectomy: impact on complications and opioid use. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Placement of prophylactic drains after laparotomy may increase infectious complications in neonates. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

Observations on wound drainage with a review of the literature. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Subcutaneous suction drains do not prevent surgical site infections in clean-contaminated abdominal surgery-results of a systematic review and meta-analysis. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the potential complications of surgical wound drainage in primary total hip arthroplasty: a prospective controlled double-blind study. [2022]