Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02926521 |
| Other study ID # |
IRB-P00021819 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2021 |
| Est. completion date |
June 2023 |
Study information
| Verified date |
January 2022 |
| Source |
Boston Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators' objective is to evaluate whether any of the various peripheral nerve block
catheter dressing strategies currently employed by the Boston Children's Hospital Regional
Anesthesia Service has any differential impact on specific outcome endpoints such as regional
block catheter dislodgement, catheter occlusion, catheter leakage, skin irritation, and skin
infection.
Description:
Generally speaking, the goals of affixing and dressing a peripheral nerve block (PNB)
catheter include preservation of the position and integrity of the catheter, the integrity of
the skin, and avoidance of infection. In order to accomplish this, nerve block catheters at
Boston Children's Hospital (BCH) are affixed to a patient's skin and dressed in a number of
ways, usually based on provider preference.
Just as care providers routinely employ several combinations of tape, occlusive dressings and
skin preparations to secure and protect intravenous catheters (all thought to be
standard-of-care based on their frequency of use), so do the members of the regional service
dress PNB catheters with various combinations of catheter anchors, Dermabond, Mastisol, and
Tegaderms. The exact combinations are based on physician preference and/or habit, though all
dressing schemes generally employ at minimum a standard catheter anchor (provided by the
catheter manufacturer) and a Tegaderm, frequently with the addition of either Mastisol or
Dermabond or both in combination. The four possible combinations in current use are:
1. Catheter anchor and Tegaderm only; 2. catheter anchor, Mastisol and Tegaderm; 3. catheter
anchor, Dermabond and Tegaderm; 4. catheter anchor, Mastisol, Dermabond and Tegaderm
As no formal record is kept of dressing type and/or components, there is no accurate way of
quantifying the frequencies of these dressing types being employed much less whether certain
dressing strategies historically have been more effective than others maintaining the
integrity of the catheter and surrounding skin.
These variations in routine practice suggest that there is not agreement about the benefits
of adding either Mastisol or Dermabond (or both) to a dressing scheme, especially given their
potential liabilities which include skin irritation (Mastisol, anecdotal at BCH), expense
(Dermabond, approximately $20/use) and time (a couple of minutes drying time for each of
these added elements).
Mastisol is a waterproof, clear liquid adhesive that has largely replaced tincture of benzoin
as part of occlusive dressings (for nerve block catheters, IVs, arterial and central lines)
as it is reported to have a significantly lower risk for skin irritation (1). As such,
Mastisol has essentially become a standard of care for skin fixation and dressing of numerous
catheter types. Papers in both the adult and pediatric regional anesthesia literature cite
the use of Mastisol as a routine component of catheter fixation and dressing as well (2-4).
However, there is little data in the literature evaluating the efficaciousness of Mastisol
insofar as reducing catheter leakage or dislodgement and hence justifying its continued use
as a part of catheter dressings. One study on healthy adults demonstrated differential forces
required to dislodge a taped IV catheter with or without Mastisol (64 ± 1 vs. 46 ± 2 Newtons)
however there is no data about catheter dislodgement rates over time in a clinical setting
(5). One case report in the pediatric literature proposes a theoretical benefit of Mastisol
use insofar as preventing regional anesthesia catheter dislodgement, but it too provides no
clinical data (6).
Dermabond is a cyanoacrylate tissue adhesive that forms a strong bond across apposed wound
edges, allowing normal healing to occur below and serving as a barrier to bacterial
infiltration of the wound. It has been marketed to replace sutures that are 5-0 or smaller in
diameter for incisional or laceration repair. This adhesive has been shown to save time
during wound repair, to provide a flexible water-resistant protective coating and to
eliminate the need for suture removal. Like Mastisol, Dermabond has become a commonplace
addition to PNB catheter dressings for securement and puncture/insertion site closure both at
BCH and nationally. And again, like Mastisol, there is little available data regarding
whether Dermabond use as a part of the dressing scheme makes any difference insofar as
catheter dislodgment or prevention of infection. A case series of three patients has been
reported as recently as 2003 that described inclusion of Dermabond as a technique offering a
simple, alternative method to secure a catheter for a prolonged period of time yet offered no
qualitative or quantitative outcomes data (7). Other, more invasive, methods to fasten
catheters have been advocated as well, such as suturing, retrograde subcutaneous tunneling
(8), and cutaneous sutures (9).
Providers at BCH and elsewhere do not so much disagree as to what is the correct dressing for
a nerve block catheter might be as they simply do not have relevant data to guide their
decision-making. The physicians at BCH and at other institutions are using that method they
believe is best by incorporating their own personal experiences as well as those of other
clinicians. All agree that the primary goals, or benefits, of a good dressing system would be
effective catheter stabilization, prevention of catheter occlusion or leakage, keeping the
site clean and dry, and avoidance of infection. To-date, however, nerve block catheter
dressings have not been studied in any rigorous way that might evaluate the various
techniques for such outcomes.
There is scant literature available on this topic generally, despite a dressing's presumed
importance in maintaining the appropriate position of the nerve block catheter and tip for
maximal efficacy. The literature, if it can be called that, is largely comprised of numerous
YouTube videos describing dressing and securing methodologies for nerve catheters (10);
however none have been reported as having been evaluated in any rigorous prospective or
retrospective analysis. (Reference to this general category of YouTube videos is made here as
they essentially are a source of, and reflect, the standard of care and as such indicate the
relative lack of rigorous evaluation of catheter securing techniques currently available).
Therefore the investigators wish to study whether the addition of Mastisol, Dermabond or both
to PNB catheter dressings here at BCH has any influence on outcomes such as catheter
dislodgment or function, skin integrity, and avoidance of infection. As such, the
investigators propose a prospective, randomized study of equivalence of dressing type with
the hypothesis that there is no more than a 10% difference in the rate of catheter
dislodgement (the primary endpoint) between the 4 commonly used dressing schemes for PNB
catheters at BCH.
