Surgical site infections are one of the top causes of postoperative morbidity and death worldwide, but there is little agreement and much debate over the most effective wound dressing to improve outcomes and reduce the health care burden.
Recent clinical trials have indicated that transparent, semiocclusive films have advantages over gauze held by adhesive tape.
But current transparent film bandages may become dislodged during activities such as showering, say authors of a pilot study published in thePatients may not realize the bandage has been disrupted, which can lead to infection.
“Clinicians, patients, and caregivers are alerted to the loss of dressing integrity and can replace the dressing when any portion of the perimeter changes to a blue [color],” the authors explain. “In addition, the dressing turns blue when the central pad is saturated with fluid, allowing the patient or provider to change the dressing.”
DSD is indicated for wounds that have low levels of exudate.
Two transparent film dressings compared
Researchers recruited 20 patients from the general population in Pittsburgh, for a small pilot study to test DSD against a comparator film dressing (3M Tegaderm + Pad). The volunteers received “a small stipend,” according to the paper.
A 1.5-centimeter incision was made in both forearms of each volunteer. The forearms were randomized regarding which got which bandage. Both bandages have been cleared by the U.S. Food and Drug Administration as nonsignificant-risk devices.
Volunteers were instructed to wear the dressing and continue their typical activities of daily living.
The average age of the volunteers was 52 years (range, 20-80 years). Among the 20 volunteers, 11 reported no comorbidities, and 45% reported at least one comorbidity.
Most of the volunteers favored DSD over the comparator in a postoperative survey – 75% to 25%, according to the report.
The wear time between the two transparent dressings across all subjects was 1.4 days. There was no difference in wear time, logged by the volunteers, between the two groups.
There were no infectious complications, the paper states.
The maker, DrySee (Houston), which holds three patents on the product, supported the research with an unrestricted grant.
DrySee CEO Brad Greer told this news organization, “With DrySee, you know when to change your dressing. All other dressings look the same wet, saturated, or dry.”
He said the study confirms what they have seen in practice, adding that the product is unique.
“No one else in the world has this technology,” Mr. Greer said.
Surgeons want to see more data
Heather Evans, MD, a general surgeon with the Medical University of South Carolina, MUSC Health, Charleston, who was not involved with the study, praised the color-indicator design and said she liked the bandage’s narrow indication for low-exudate wounds.
She said in an interview, “It’s a lot to put on a layperson to suddenly know how to take care of wounds when you leave the hospital.”
Giving them the confidence that their wound is safe if the blue doesn’t appear “is a really cool concept,” she said.
She said that, although the volunteers included some elderly people and people with conditions such as diabetes that could affect, the bandage needs to be tested with a bigger trial to see if it is effective outside controlled conditions.
She also said that some occlusive dressings will be more durable and stay on days longer than DSD or the comparator, which may affect the choice for some.
“The average length of dressing time in this study was less than 2 days,” she pointed out.
Jim Rickert, MD, an orthopedic surgeon with Indiana University Health Bedford, who was not involved with the study, agreed that any surgical or wound dressing, including transparent films, can become dislodged, and said, “This type of product has promise but this is a small pilot study. I would want to see results from a trial of actual surgical patients to see if this type of dressing did indeed decrease post-op infections compared to standard dressing materials.”
Not all are convinced either that there is a need to be filled or that DSD will be the right solution.
Therese Duane, MD, a general surgeon with Texas Health Harris Methodist Fort Worth, who was not part of the study, said in an interview that she “has no issues with the current products.”
She added that more information is needed before considering DSD a better solution, including animal studies and use “on very sick patients.”
“Twenty volunteers with cuts on their arm is barely a start for comparison,” she said.
The authors, led by Kristy Breisinger, a research analyst with the SerenaGroup Research Foundation in Cambridge, Mass., acknowledged the limitations, including the small sample size and that the trial was conducted at only one institution. Additionally, the analysis is based on descriptive statistics.
They write that the trial design was chosen “to simulate a real-world setting that is not always achievable in animal studies.”
The research was sponsored by an unrestricted grant from the maker of DSD, DrySee Inc., in Houston.
Mr. Greer is DrySee’s CEO. The authors and Dr. Duane, Dr. Rickert, and Dr. Evans declared no relevant financial relationships.
A version of this article first appeared on.