|Year : 2020 | Volume
| Issue : 1 | Page : 27-31
Comparison of skin closure technique with stapler and subcuticular suture in patients with inguinal hernia undergoing lichtenstein tension-free mesh repair – An open-label randomized controlled trial
Sathasivam Sureshkumar1, Datta Souraja1, Elangovan Archana1, Sahla Sathar1, Thulasingam Mahalakshmy2, Chinnakali Palanivel2, Vikram Kate1
1 Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
2 Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
|Date of Submission||27-Feb-2020|
|Date of Acceptance||18-May-2020|
|Date of Web Publication||18-Aug-2020|
Dr. Vikram Kate
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry - 605 006
Source of Support: None, Conflict of Interest: None
Background: Both subcuticular suturing and stapler closure are used for skin closure. However, the superiority of one over the other is yet to be established clearly. Aims: This study compares the efficacy of skin closure technique by stapler and subcuticular suture in patients undergoing Lichtenstein repair for inguinal hernia. Methods: Elective inguinal hernia repair patients were randomized to undergo skin closure using either subcuticular sutures or staplers. Skin closure time in minutes, postoperative wound site pain using the Visual Analog Scale, wound cosmesis and scar outcome using the Patient and Observer Scar Assessment Scale, and patient satisfaction using the Likert scale were assessed. Results: A total of 38 patients with inguinal hernia were included: 20 in subcuticular suture group and 18 in stapler group. The scar outcomes assessed by patients (3.05 ± 1.83 vs. 4.94 ± 2.54; P = 0.0013) and observers (2.83 ± 0.98 vs. 4.44 ± 1.67; P = 0.0105) were significantly better in the subcuticular group. The time taken for skin closure was significantly longer in the suture group (P < 0.001). There was no significant difference between the two groups in terms of postoperative wound pain (P = 0.65), patient satisfaction (P = 0.238), and outcome of wound healing (P = 0.900). Conclusion: The cosmetic outcome of skin closure with subcuticular suture was better. Time taken for skin closure using staplers was shorter compared to suturing. Postoperative wound pain, patient satisfaction, and wound healing were similar between the two groups.
Keywords: Patient satisfaction, postoperative wound pain, skin closure, visual analog scale, wound cosmesis
|How to cite this article:|
Sureshkumar S, Souraja D, Archana E, Sathar S, Mahalakshmy T, Palanivel C, Kate V. Comparison of skin closure technique with stapler and subcuticular suture in patients with inguinal hernia undergoing lichtenstein tension-free mesh repair – An open-label randomized controlled trial. Int J Adv Med Health Res 2020;7:27-31
|How to cite this URL:|
Sureshkumar S, Souraja D, Archana E, Sathar S, Mahalakshmy T, Palanivel C, Kate V. Comparison of skin closure technique with stapler and subcuticular suture in patients with inguinal hernia undergoing lichtenstein tension-free mesh repair – An open-label randomized controlled trial. Int J Adv Med Health Res [serial online] 2020 [cited 2020 Sep 20];7:27-31. Available from: http://www.ijamhrjournal.org/text.asp?2020/7/1/27/292399
| Introduction|| |
Skin closure is an integral step of nearly every surgical procedure. Of the several factors which can influence the outcome of wound healing in a surgical procedure, factors intrinsic to the patient are often nonmodifiable.,, However, extrinsic factors, especially those pertaining to aseptic conditions, the surgical technique, and perioperative wound care, are potentially modifiable and thus can reduce rates of wound complications.
If the closure device fails to provide adequate support to the skin tissue, the wound edges may open up, potentially leading to wound infection, poor cosmesis, and low patient satisfaction. Postsurgical complications such as infection can result in prolonged hospitalization and impose a considerable economic burden on the patient as well as the health providers.
As in any other surgery, wound closure is of paramount importance in hernioplasty as well. Staplers are frequently used in various types of surgeries, including hernia repair surgeries, owing to their ease and rapidity of use. However, subcuticular suturing for skin closure provides a more favorable cosmetic result and fewer wound complications. For this reason, several randomized trials have recommended this technique in clean surgeries such as orthopedic surgery, cardiovascular surgery, and cesarean section.,, However, in trials involving colorectal and open abdominal, surgeries, subcuticular suturing was not found to be superior to that of stapler closure.
Only a limited number of studies are available with varying results comparing the skin closure with subcuticular suturing and stapling. Hence, this study was carried out to compare these techniques in terms of wound cosmesis, postoperative pain, and duration of skin closure.
| Methods|| |
The study was a single-center, prospective, open-label, parallel-arm, randomized controlled trial carried out in the Department of Surgery, JIPMER, from May 2018 to August 2018. The study was approved by the JIPMER Undergraduate Research Monitoring Committee and Institute Ethics Committee. The study was registered at www.ctri.gov.in, CTRI number: CTRI/2018/08/015470.
All consecutive patients, of age 18 years and above, diagnosed with inguinal hernia and undergoing elective open Lichtenstein tension-free mesh repair in the Department of Surgery, JIPMER, Puducherry, were included in the study. Patients with complications such as recurrence, obstruction, and strangulation and those who were operated in emergency settings were excluded. Written informed consent was taken from all the participants, and patients were informed that they could withdraw from the study at any point during the study period.
Following informed consent, patients were randomly assigned to undergo skin closure either by subcuticular sutures or by staples (“suture” and “stapler” groups, respectively). Block randomization was done using computer-generated random numbers with block sizes of 4 and 6. Randomization was done before the surgical procedure. Allocation concealment was done by the Serially Numbered Opaque Sealed Envelope technique. Sealed envelopes were prepared by a person independent of the investigators. The envelopes were opened by the nurse and group allocation was done before starting the surgery and necessary skin closure material was given to the nursing assistant. The operating surgeon was informed about the closure technique immediately before the skin closure. This was an open-label trial, and neither the patient nor the observer was blinded for the method of skin closure.
All the surgical procedures were carried out under spinal anesthesia. One dose of prophylactic antibiotic was given with intravenous cloxacillin 500 mg before the skin incision. Standard steps of surgery were followed with mesh fixation using 2-0 prolene. External oblique aponeurosis was closed with 2-0 prolene. Subcutaneous tissue approximation was not done routinely and was decided by the operating surgeon based on the thickness of the subcutaneous tissue. In the stapler group, the dermis of each edge was attached using metallic skin staples 10–15 mm apart. In the suture group, continuous subcuticular suture with 3-0 Monocryl was used to attach the dermis of each edge, with an interval of 15–25 mm and the length of the bite of sutures 15–25 mm from the edge of the skin. Wound was then covered with sterile dressing and was opened after 48 h to check the wound status. Patients were started on oral fluids after 8 h and solid diet after 24 h. Standard postoperative protocol to achieve tolerance of fluids and diet before discharge was followed.
Outcome parameters studied
The primary outcome of the study was to compare the cosmetic outcome of the wound between the two skin closure methods as measured on the 30th postoperative day using the Patient and Observer Scar Assessment Scale (POSAS) scale. The secondary outcomes include comparison of the time taken for skin closure in minutes, postoperative wound pain assessed by the Visual Analog Scale (VAS) at 24 h postoperatively, outcome of wound healing, and patient satisfaction at 30 days assessed by the Likert scale between the two skin closure methods.
Data were collected using a specified proforma. Skin closure time was measured intraoperatively from the starting of the skin closure to the end of skin closure in minutes, and the length of skin incision was measured in centimeter. Postoperative wound site pain was assessed using VAS at 24 h as all patients were given two doses of injectable analgesics at 8 hourly interval after surgery and assessment of pain before 24 h might be influenced by the analgesic effect, masking the effect of skin closure technique on the wound pain. For wound cosmesis and scar outcome, a previously validated 6-point Patient and Observer Scar Assessment Scoring (POSAS) tool was used. It consisted of a “total score” ranging from 6 to 60 (6 indicating the best and 60 the worst scar outcome) and an “overall opinion” ranging from 1 to 10 (lower score indicating better outcome) in both the patient and observer scales. The assessment was done on the 30th postoperative day. Patient satisfaction was assessed using the Likert five-point scale, with 5 indicating “very satisfied,” 4 “satisfied,” 3 “neutral,” 2 “dissatisfied,” and 1 “very dissatisfied.”
As the study was carried out as a pilot project, no sample size was calculated. All eligible patients over the study period of 2 months were included in the study. The data were entered in MS Excel and analyzed using (StataCorp. 2019. Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC) (STATA). Per-protocol analysis was done for the trial. Unpaired student's t-test was used for comparing normally distributed data such as age distribution and time taken for skin closure between the two groups. The Chi-square test was used to compare the prevalence of comorbidities and outcome of wound healing between the two groups. The Mann–Whitney U-test was used for data with non-normal distribution such as postoperative wound site pain (VAS) and wound cosmesis (POSAS).
| Results|| |
Between June and July 2018, 44 patients with inguinal hernia were assessed for eligibility. After exclusion of six patients, the remaining 38 were enrolled and randomly assigned – 20 to subcuticular sutures and 18 to staplers (henceforth the “suture” and “stapler” groups, respectively). The CONSORT flow diagram for the trial is depicted in [Figure 1]. Subsequently, four patients were excluded from analysis due to loss to follow-up.
The baseline patient characteristics were well balanced, except for the age and prevalence of hypertension [Table 1]. The mean age of the suture group was 41.1 years and that of the stapler group was 49.8 years (P = 0.03). Four patients in the suture group were found to be hypertensive but none in the stapler group (P = 0.04). Three patients in the suture group and five patients in the stapler group had diabetes, and this difference was not statistically significant (P = 0.33). The body mass index between the two groups were comparable (26.1 ± 0.22 vs. 25.3 ± 0.24 kg/m2; P = 0.14).
Our primary end point was cosmetic outcome of the wound as measured on the 30th postoperative day by the POSAS scale [Table 2]. The mean “total score” (obtained as a sum of the scores of 6 components of the POSAS scale) between the suture and stapler groups as assessed by the patients (19.0, 17.75) and the observers (17.11, 19.19) was found to be similar. However, the “overall opinion,” which is scored separately from the “total score,” significantly differed among the two interventions. Scar outcome of subcuticular suture was better according to mean patient score (3.05 ± 1.83) and mean observer score (2.83 ± 0.98) as compared to staplers (4.94 ± 2.54 and 4.44 ± 1.67) (P = 0.0013 and P = 0.0105).
|Table 2: Primary outcome - wound cosmesis, as per patient and observer scar assessment scale scores on postoperative day 30|
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[Table 3] summarizes the details of the secondary outcomes. The time taken for skin closure was significantly longer in the suture group (P < 0.001). The postoperative wound pain assessed using the VAS at 24 h postoperatively was comparable in both the groups (P = 0.65). Patient satisfaction did not significantly differ between the two interventions (P = 0.238). Outcome of wound healing was also similar between the two groups, with two patients in each group healing with residual inflammation (P = 0.900).
|Table 3: Secondary outcomes - time taken for skin closure, postoperative pain, patient satisfaction, and wound healing outcome|
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| Discussion|| |
The role of the external skin closure device in influencing the scar outcome and wound complications following a surgical procedure has been an area of considerable research. However, there is no clear consensus in the literature regarding the benefit of subcuticular suture over stapler closure, with several studies claiming conflicting results.,,, To the best of our knowledge, this is the first prospective randomized study done in the Indian population comparing the efficacy of skin closure between staplers and subcuticular sutures in patients with inguinal hernia undergoing Lichtenstein tension-free mesh repair, with cosmetic outcome of the wound being our primary end point.
Four patients, two in each group, were lost to follow-up. The mean age of the two groups differed significantly from each other, probably as a result of the small sample size. The total score of the Patient and Observer Scar Assessment Scale did not differ significantly between the two groups, indicating that cosmetic outcomes of both were comparable. Two separate studies done on postcesarean section patients in Alabama, USA, and Nigeria, reported similar findings. However, in our study, the overall opinion regarding the appearance of the scar, which is assessed separately from the total score, was significantly lower in the suture group in both the patient and observer groups, with a lower score indicating better outcome. Although the reason for the difference in the outcome based on the total score was unclear, it is possible that the patients in the two groups are lesser in number to find the statistical difference in the total score, however, sufficient to find the difference in the overall opinion score. Studying the scar outcome in a larger population may give more insights into this apparent difference.
The time taken for skin closure, measured as centimeter per minute, was faster in the stapler group than the suture group, consistent with the findings of Rousseau et al. and Basha et al. The suturing involves handling of needle and suture to approximate the dermis edges, making sure the edges are approximated without overhanging and inequality at the corner. Whereas, the stapling technique is easier as it requires lesser technical skill, and the concern about overhanging edges and inequal corner are lesser. The apparent difference in the simplicity of the technique and the lesser skill required may be favoring the stapling to consume lesser time for skin closure.,,, Postoperative pain at the incision site was comparable in both groups, which was similar to findings from other studies., In our study, patient satisfaction did not significantly differ between the two interventions (P = 0.238). This correlated with the findings of Basha et al., who reported that incidence of wound complications including surgical site infection and inadequate approximation was the main factor influencing patient satisfaction, and after adjusting for this confounding variable, there was no significant difference in patient satisfaction regarding method of skin closure. Staple removal may cause discomfort to the patients and may lead to patient dissatisfaction. The study did not evaluate the patient dissatisfaction or acceptance of staple removal, however, this outcome could be more useful in studying the benefit of using subcuticular absorbable suture and can be included in future studies.
The major limitation of this study was its small sample size, which may have resulted in contradictory findings. Due to the small sample size, we were also unable to adequately analyze the incidence of wound infection and complications.
| Conclusion|| |
The cosmetic outcome of skin closure with subcuticular suture was perceived to be better by both patients and observers as per the “overall opinion” of POSAS score. However, calculation of the “total score” showed no significant difference between staplers and suture groups. Time taken for skin closure using staples was significantly less compared to the time taken for subcuticular skin closure by suturing. Postoperative wound pain, patient satisfaction, and wound healing were similar between the two groups.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]