Staples Equal Sutures for Skin Closure After Soft Tissue Tumor Resection
Hits:1266
Time:2019-05-01 00:40:30 |
Wound closure accounts for a relatively constant portion of the time required to complete a surgical case. Both longer closure times and wound infections contribute to higher medical costs and patient morbidity.
We therefore determined whether (1) biologic and treatment factors greater influenced wound healing than the choice of sutures or staples; and (2) different times to closure affected cost when sutures or staples are used in patients with musculoskeletal tumors.
We retrospectively reviewed 511 patients who had sarcoma resections of the buttock, thigh, and femur from 2003 to 2010; 376 had closure with sutures and 135 with staples. Data were abstracted on patient demographics, comorbidities, select procedural data, and wound complications. Wound complications were defined by hospitalization within 6 months postoperatively for a wound problem, irrigation and débridement, or infection treated with antibiotics. We determined the association between staples versus sutures and wound complications after controlling for confounding factors. The minimum followup was 2 weeks. A prospective, timed analysis of wounds closed with either sutures or staples was also performed.
We found an association between obesity and radiation and wound complications. Wounds were closed an average of 5.3 minutes faster with staples than with suture (0.29 minutes versus 5.6 minutes, respectively), saving a mean 2.1% of the total operating time although the total operating time was similar in the two groups.
We found no difference in wound complications after closure with sutures or staples, although obesity and radiation treatment appear to affect wound outcomes. Data suggest that time saved in the operating room by closing with staples compensates for added material costs and does not compromise wound care in patients with lower extremity sarcomas.
Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence
The selection of skin closure method for orthopaedic procedures is influenced by several factors, including the ease of closure, speed, cost, and potential complications such as wound infection and dehiscence [20]. During the past three decades, orthopaedic surgeons have had many choices for superficial wound closure, including metal staples or nylon sutures [8].
Initially this decision was guided solely by physician preference; however, as concerns about cost, poor wound outcomes, and patient satisfaction have become increasingly important, attention has been focused on demonstrating a clear benefit of one method over the other to guide practice [3, 7, 9, 18–21]. No clear advantage between sutures or staples has been demonstrated, and authors have attempted to show the advantages of each method. It has been argued that staples are more cost-effective, easier to use, and faster for closing wounds [6, 11]. Additionally, recent data have indicated that staples may be associated with higher risks of wound infection after orthopaedic procedures [20]. Other studies have shown that obesity, acute radiotherapy, and other comorbidities affect wound healing [10, 12, 17]. However, the combined influence of these patient characteristics and wound closure methods on wound outcome has not been adequately investigated.
We therefore determined whether (1) biologic and treatment factors would have a greater influence on wound healing than the choice of sutures or staples; and (2) the times to closure and cost differ when sutures or staples are used in patients surgically treated for musculoskeletal tumors.
With prior institutional review board approval, we retrospectively reviewed the records of 681 patients who had sarcoma resections of the buttock, thigh, and femur from 2003 to 2010. Patients were identified by searching a financial database for Current Procedural Terminology codes 27047, 27048, 27049, 27328, 27329, 27364, 27365, and 27059 and then identifying patients having undergone radical resections or excisions of the pelvis, thigh, or buttock. Excisions and resections were defined according to the MSTS-accepted Enneking definitions for these procedures [4]. Data were collected from the patients’ electronic medical records and were managed using REDCap™ electronic data capture tools hosted at Vanderbilt University. Patients were excluded if (1) wounds were closed by nonorthopaedic teams (N = 14); (2) there was no 2-week followup visit (N = 17); (3) if death occurred within 1 month (N = 8); (4) amputation within 3 months of the procedure (N = 3); or (5) the operation involved reconstruction with a wound flap, use of wound vacuum-assisted closure, or skin graft (N = 12). For patients with excisions followed by resection, only the final definitive procedure was included. Of 681 patients reviewed, 54 were excluded and 511 met inclusion criteria. Of those patients, 64% had operations involving the thigh (Table 1).
Characteristics | Sutures (N = 376) | Staples (N = 135) | p value |
---|---|---|---|
Patient characteristics | |||
Age, mean years (SD) | 49.5 (20.7) | 52 (18.4) | 0.30 |
Male | 178 (47%) | 58 (43%) | |
Female | 198 (53%) | 77 (57%) | 0.38 |
Diabetic | 43 (11%) | 27 (20%) | 0.01 |
Smoker | 130 (35%) | 40 (30%) | 0.30 |
Obese (body mass index > 30 kg/m2) | 109 (29%) | 42 (31%) | 0.64 |
Surgery characteristics | |||
Location: buttock | 54 (14%) | 14 (10%) | |
Location: femur | 80 (21%) | 37 (27%) | |
Location: thigh | 242 (64%) | 84 (62%) | 0.24 |
Length of incision, mean (SD) | 17.9 (10.6) | 18.3 (13.5) | 0.47 |
Incision: straight | 243 (65%) | 112 (83%) | |
Incision: curvilinear | 22 (6%) | 8 (6%) | |
Incision: other | 111 (30%) | 15 (11%) | < 0.001 |
Drain use | 213 (57%) | 84 (62%) | 0.26 |
Tumor characteristics | |||
High-grade dysplasia | 229 (61%) | 87 (64%) | |
Low-grade dysplasia | 147 (39%) | 48 (36%) | 0.47 |
Tumor size, mean (SD) | 11.7 (7.2) | 10.3 (7.7) | 0.01 |
Final pathology | |||
Primary sarcoma | 189 (50%) | 51 (38%) | |
Benign tumor | 155 (41%) | 67 (50%) | |
Metastatic disease | 32 (9%) | 17 (13%) | 0.04 |
Treatment characteristics | |||
Chemo pre-/postoperative | 70 (19%) | 25 (19%) | 0.98 |
Radiation pre-/postoperative | 163 (43%) | 43 (32%) | 0.02 |
Complications | |||
Wound complication | 41 (11%) | 7 (5%) | 0.08 |
Infection | 23 (6%) | 5 (4%) | 0.40 |
Surgical débridement | 6 (2%) | 4 (3%) | 0.53 |
Surgical protocols were standardized across the cohort; all patients received a chlorhexidine scrub in holding, Betadine (Purdue Pharma, Stamford, CT, USA) wash and DuraPrep (3M, St. Paul, MN, USA) in the operating room, and were treated with 24 hours of cephalexin. Patients for only two surgeons were used (GH, HS), who preferred closing with either sutures or staples. All cases were conducted in the same operating rooms with an experienced surgical team dedicated to this division. In all patients, fascia was closed with 0 Vicryl (Ethicon, Somerville, NJ) sutures and subsequent layers deep to the dermis with 2-0 Vicryl sutures. Cutaneous wound closure with either staples or nylon sutures was identified in the operative note and recorded; 376 patients underwent surgical closure with sutures and 135 with staples. Wounds were closed by attendings, residents, or first assistants with either staples or 3-0 nylon sutures using a simple interrupted stitch.
Length of incision, antibiotics used, method of closure, and drain use were obtained from operative reports or discharge summaries. In < 5% of patients, length of incision was not recorded so tumor size was used as a surrogate. For patients with multiple incisions for more than one tumor, the largest incision and tumor were included. The average length of incision and tumor size was 18 ± 13 cm and 11 ± 7 cm, respectively. Tumor type and size were based on final pathology reports. The final diagnosis was primary sarcoma in 47% of patients with high-grade dysplasia being found in 38% of patients.
Comorbidities and patient demographics were determined through chart review. Radiation exposure was defined as therapeutic radiation to the operative site 1 month before or 1 month after surgical intervention. Patients with recurrent disease were only considered to have been irradiated if therapy occurred within 1 month of surgery. Patients with metastatic disease to bone with irradiation at the primary site were not considered radiation-exposed. Chemotherapy was defined as neoadjuvant or adjuvant chemotherapy either 1 month before or after surgical intervention. Pre- or postoperative radiation was documented in 40% of patients, wound complications (defined subsequently) in 9% of patients, and wound infection in 6% of patients. Patients closed with sutures tended to have less diabetes (11% versus 20%), larger tumors (12 cm versus 10 cm), more perioperative radiation (43% versus 32%), and more wound complications (11% versus 5%) (Table 1).
Wound complications were collected from followup clinic visit notes, hospitalizations, and operative reports. The minimum followup was 2 weeks (range, 2 weeks to 6 months). Patients were identified as having a wound complication if (1) they were hospitalized within 6 months postoperatively for a wound-related complication; (2) they ever received in-clinic or operative irrigation and débridement; or (3) they had infections described in clinic notes and were treated with antibiotics. Warmth, erythema, discharge, seromas, dehiscence, or postradiation changes without specific mention of infection or treatment were not considered wound complications.
To determine closure time, we prospectively observed 10 patients with 20- to 30-cm wounds in which the decision to close with sutures or staples had been predetermined by the surgeon. Wounds were marked off into 10-cm segments, and the time to closure was measured in minutes. A total of 10 measurements were made for both sutures and staples. These were compared with total operating room time as outlined in the anesthetic record. Cost was determined for one package of 3-0 SH PO 18-inch nylon sutures and a 35-mm wide skin stapler (AutoSuture™; Covidien, Mansfield, MA, USA). Hospital cost was determined per 30-minute block of operating room time for each Current Procedural Terminology code, converted to cost per minute, and then averaged across the data set.
The number of study participants needed for this study was based on a sample size calculation for multiple logistic regression analysis using a method by Peduzzi et al. [13]. The estimate was based on the expected proportion of wound complications in the population (p), the number of expected covariates to include in the multivariable regression model (k), and a specified equation (N = 10*k/p). Using a conservative proportion of 0.13 and seven covariates, an alpha level of 0.05, and a power of 0.80, a sample size of 538 was needed to detect an association between closure type and wound complications, controlling for six covariates. A second a priori sample size calculation was performed to determine the sample size needed to detect a statistically significant difference in wound complications across closure type (sutures versus staples). We determined that a sample size of 494 was needed to detect a 9% difference in complications with an alpha level of 0.05 and power of 0.80. A failure to detect a difference across groups could represent a Type II error.
Descriptive statistics were used to summarize variables and to assess normality, identify outliers, determine appropriate summaries of location and spread, and assess the need for nonparametric analysis. Students’ t-tests for continuous variables and chi-square or Fisher’s exact tests for dichotomous variables were used to compare characteristics across closure groups. Bivariate logistic regression analyses were performed to assess associations between patient and clinical characteristics and wound complications. Type of closure and variables that were significant at p < 0.05 in bivariate analyses (Table 2) were entered into a multivariable logistic regression analysis. Stata statistical software (Version 11.0; Stata Corp, College Station, TX, USA) was used to analyze the data.
Variable | Odds ratio (95% CI) | p value |
---|---|---|
Sutures versus staples | 2.2 (0.98–5.1) | 0.06 |
Age | 1.02 (1.01–1.04) | 0.01 |
Obese versus not obese | 2.2 (1.2–4.0) | 0.01 |
Diabetic versus nondiabetic | 1.5 (0.70–3.3) | 0.29 |
Smoker versus nonsmoker | 1.2 (0.66–2.3) | 0.51 |
Buttock versus thigh/femur | 0.92 (0.38–2.3) | 0.86 |
Length of incision | 1.05 (1.03–1.08) | < 0.001 |
Drain versus no drain | 4.0 (1.8–8.8) | < 0.001 |
Tumor size | 1.1 (1.03–1.1) | 0.001 |
Benign tumor versus others | 0.13 (0.05–0.34) | < .001 |
Chemotherapy versus no chemotherapy | 0.60 (0.25–1.5) | 0.26 |
Radiation versus no radiation | 7.7 (3.6–16.2) | < 0.001 |