As usual, naive media, including The New York Times, accepted the study's findings without reservations. Also as usual, I did not.
Here's why.
I actually read the full version of the paper, which appeared in the June issue of Obstetrics and Gynecology.
My major concern is this (from the paper): Staples were removed on postoperative days 4–10 at the discretion of the health care provider. In fact, staples were removed at a median of 6 days. That means half of the patients, who had an average BMI of 32.5, had their staples removed in 6 or fewer days.
Of the stapled group, 216 (57.6%) patients returned after discharge for removal and 160 (42.4%) had their staples removed before hospital discharge which averaged 4.5 days.
I would never remove staples from an abdominal incision in fewer than 7-10 days, especially in an obese patient. The only reasons to remove staples before discharging a patient would be to avoid scheduling an office visit within a week or so after the hospitalization or to save the doctor's office the cost ($1.95 to $9.99) of purchasing a disposable staple remover.
The most common wound complication was separation of the skin. From the paper: The majority of patients who had a wound separation either healed spontaneously or had Steri-Strips placed. Two patients required wound packing (one in the suture group, one in the staple group).
Although wound separation occurred in significantly more of the stapled patients (7.4% vs. 1.6%) the median length of skin separation in the stapled group was 2 cm—less than 1 inch—and not a big deal.
The authors acknowledge that the skin wound separations caused almost no problems for the patients.
More from the paper: The decreases in the individual rates of wound infection, hematoma, seroma, or readmission for a wound complication in the suture compared with the staple group were not statistically significant.
What this paper shows is that if you remove staples before wounds have had enough time to complete the initial phase of healing, separation of the skin, which is not a serious problem, will occur in some patients.
Bottom line: If you don’t take staples out too soon, it's OK to use them to close the skin, and as the paper found, you will save an average of 9 minutes of OR time.
PS: There were two interesting misrepresentations in the NY Times article about the paper. One, The study, which received funding from Ethicon, a maker of sutures… failed to mention that Ethicon also makes skin staplers. Two, Stitching takes about nine minutes longer than stapling. But in a C-section, Dr. Berghella [the study's senior author] said, where local anesthesia is generally used, that time difference is unimportant. Local anesthesia for a C-section? The article was obviously written by a man. He must have meant spinal or epidural.
27 comments:
Sutures must be more expensive than staples, but I wouldn't have thought so. Did the paper state the method of suture closure, sub cuticular or interrupted?
Suture closure was "subcuticular continuous 4-0 suture (poliglecaprone or polyglactin)." I believe that staples are more expensive than sutures, but the savings in OR time would negate that difference. I was going to discuss the financial aspects, but it is hard to find out the true costs (not charges) for staples, staple removers, sutures, and OR time.
Then I wonder what Ethicon's game is. Maybe they have an oversupply of suture material?
Have almost always used subcuticular closure for CS incisions in 19 years of practice--they seem much more comfortable for the patient (that just-pregnant abdomen always folds over at least a little bit) and more convenient for us rounding without having to removed staples. Patients dread that much more than I ever suspected. That said, most women go home postop day #3 after CS and when I did staple, staples were always removed just prior to discharge (to your point, though, we always put steristrips on after removal). Don't remember anyone in any of the 4 states I've worked or trained in leaving pfannenstiel staples in for more than 4-5 days....
Artiger, I'm not sure why Ethicon funded the study. I know it's hard to believe, but they may have actually done it without any hidden agenda.
Anon, thank you for commenting. I defer to your personal experience with the surgery. I have no preference or preconceived idea about whether sutures or staples are better for closing cesarean section incisions. I am more concerned with the methodology of the research paper and its conclusion that staples cause more wound complications than sutures.
Since the time of staple removal was not standardized, and my experience tells me that removing staples early is more likely to result in gaping of the skin, I don't think the authors are justified and categorically stating that more wound complications result from stapling. The points you raise are pertinent but not addressed by the paper in question.
Have you applied for jobs, freelancing, telling these papers what to look for in terms of how they might not appear to be as good resources for medical information as they think they are?
Maybe Dr. Oz or Dr. Phil are the ones running their approval dept.
Anon, thanks for the suggestion, but the media are not looking for truth. They want to get clicks. It's a better story for them if staples are portrayed as evil instruments of the devil.
The OR scheduling anesthesiologist told me once that our academic medical center accounted for OR time at roughly $100/minute in costs to the "system", including everything from anesthesia fees, surgeon's fees, nurse/tech costs, cleaning, and supplies.
So if it is a true 9 minute savings, it could be big on a global scale.
I do have to say that patients tended to prefer suture for incisions in that area, both for immediate comfort, reduced anxiety over removal, and eventual cosmetic results.
So let me get this straight. Artiger thinks that a company who makes both sutures and staplers funded this study in an effort to get rid of their oversupply of sutures? That is totally ludicrous. I am quite certain that the cost associated with sponsoring the study would far exceed the gains of selling more suture as a result of it.
Staples are UGLY! All the patient and family see is the skin closure. I have had countless patients complain about stapled skin closure…I have never had one complain about a sutured closure.
As I mentioned above, I was going to try to address costs but there is no agreed upon standard for determining how much OR time costs. Hospitals vary widely.
I hope Artiger was kidding about what Ethicon's motives may have been.
Reviews have found that staples are associated with more wound infections in orthopedic surgery but the same or fewer infections in all other types of procedures. Staples save significant amounts of time in the OR but are more painful to remove. The cosmetic results of both staples and sutures are similar. Here are some references.
http://www.ncbi.nlm.nih.gov/pubmed/21944632
http://www.bmj.com/content/340/bmj.c1199
http://escholarship.org/uc/item/01m9k1jm
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0075132
Sutures have one other advantage: learning how to put them in properly is valuable for juniors, correct use of forceps and wrist pronation/supination etc. Staples are just too easy. But then, in the UK, we don't worry about the time costs of theatre, though staples are usually more expensive.
And taking staples/sutures out after 3-5 days after a C/S is just asking for trouble.
Yes, I was kidding. Anonymous, please turn up your sarcasm meter.
Korhomme, I agree that teaching residents and students to suture has value. I just don't think this paper makes a convincing argument for the superiority of sutures over staples for wound closure. I also agree that the authors took the staples out to early.
Artiger, thanks for confirming that you were not serious. I have found that sarcasm and irony are often hard to communicate online. Much as I dislike emoticons or pseudo-emoticons [:-)], I have begun to use them more and more.
Perhaps in the current computer-driven milieu this is impossible, but how about this:
Save time and close the wound with staples (except in the learning situation outlined above).
On the day of discharge, the surgeon examines the patient and the wound and feels everything is fine.
The surgeon writes an order for the nurse to remove the staples and apply Dermabond (OR Mastisol and Steri-Strips) to the wound. In patients with a high BMI, Dermabond is probably less likely to come off with the perspiration and moistness that can occur in the suprapubic region.
No staples to take home. No 9th day office visit for staple removal. Saves doctor time. Both methods will last long enough for the wound to repair adequately. Give patient some extra SteriStrips in case some fall off.
I tried superglue, I tried Steri-Strips. neither was very satisfactory. I usually just closed (I didn't do C/S) with a subcuticular suture of undyed Dexon or Vicryl. Nothing to be removed, and usually no problems. It's just a bit fiddly.
Robert, that might work. I never trusted Dermabond in large wounds.
Korhomme, I'd say if subcuticular suture works for you, do it. It can take a while in a big patient.
Great blog! Speaking as a layman here, but the comment of 9 minutes of saving in the OR - by the use of staples instead of sutures - reads as somewhat callous to me. Is that the bottom line? How much time/money can be saved? Is that savings to the hospital, patient or doctor? Curious about the last as recently, before undergoing surgery, took a certain amount of persuasion before the surgeon's agreement to use sutures. Do less surgeons learn to stitch in 2014?
Anon, thanks for the compliment and for commenting.
A minute of OR time can cost a patient or her insurance company anywhere from $20 to $80 (http://ether.stanford.edu/asc/documents/management2.pdf). I've heard that some hospitals charge as much as $160/minute. A surgeon doesn't receive any money for taking longer to do a case. Anesthesia charges by 15 minute increments so 9 extra minutes would also likely increase that bill too.
Suturing is definitely being done less often. For small incisions, glue is often used.
I think it's much ado about nothing. Staple removal may hurt a little more, but not so much if carefully done. The wounds look similar to sutured wounds after a few months.
Dude im sure that LA was just used for closing the skin andnot during the CS. So that reversal of anaesthesia could be done earlier while the skin was still being sutured.
Hirak, you may be correct, but the paper itself does not even mention the words "local" or "anesthesia." The time difference is important because operating room time is charged by the minute and anesthesia is billed in increments of all or parts of 15 minute blocks.
I'm not a doctor but I have anecdotal evidence to share :). I've had five c-sections all closed with staples. The last two c-sections I had skin openings of less than an inch. But there is a cost and that is an emotionally exhausted post-op mother of a newborn staring down at her abdomen with, in my mind, "A GAPING WOUND!" and all the other junk that comes with thinking, "Is it going to be infected? Is it? Is my fever from mastitis or an infection or both at the same time?" But I know that's my anxiety.
What I really care about is the staples vs. sutures idea. I live in NC. I have a mass of scar tissue around my incision and that just won't go away no matter how I massage it, etc. And my fourth and fifth c-sections KILLED me. I'm not really a baby with pain, but I could barely move with my fifth without two percocets in me, vs. not using any percocet with my first c-section. I compare my situation to three friends who have had four c-sections each in California and Seattle. They all were closed with sutures each time and barely mentioned pain. I kept asking, "Doesn't it kill? I'd just sit in my hospital bed trying not to move an inch because I hurt so much." Each of their responses (and they don't know each other). "It wasn't too bad, just about the same as the other c-sections I've had." So that right there. Isn't that a staples vs. suturing different layers. And I'll be darned if that isn't worth the extra time in the OR. I don't care about a few hundred dollars vs. decreased pain, recovery time (especially with a newborn) and decreased scarring and adhesions, etc.
S, thank you for commenting. I'm not sure that your experience plus the reports of two friends is enough to sway to pendulum toward sutures. But if you came to me for surgery and told me your story, I wouldn't even think of closing your incision with staples.
S, I'm a bit puzzled; isn't an inch long skin incision a bit small for a baby to emerge from?
I think S meant that about one inch of the wound had separated. C section wounds are quite a bit longer that an inch.
Skeptical is correct. :) (are smiley faces appropriate for a serious medical blog?!)
It's not that serious.
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