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Effect of Adhesive Strips and Dermal Sutures vs Dermal Sutures Only on Wound Closure: A Randomized Clinical Trial.

ABSTRACT: Although applying adhesive strips to a wound closure has been shown to have outcomes equivalent to those with cuticular suturing, it is unknown whether adhesive strips provide additional benefit compared with dermal suturing alone.To determine whether the addition of adhesive strips to a wound closed with buried interrupted subcuticular sutures improves outcomes following wound closure.A prospective, randomized split-wound intervention was conducted between November 14, 2013, and May 16, 2014, in patients who underwent cutaneous surgical procedures at the University of California, Davis, outpatient dermatology clinic. Fifty-seven patients 18 years or older with postoperative defects of at least 3 cm, resulting from either Mohs micrographic surgical procedures or surgical excision, were screened for participation. Nine patients were excluded and 48 were enrolled.Half of each wound was randomized to receive buried interrupted subcuticular sutures and overlying adhesive strips and the other half received buried interrupted subcuticular sutures only.At 3 months' follow-up, each patient and 2 blinded observers evaluated the wound using the Patient Observer Scar Assessment Scale.The total mean (SD) Patient Observer Scar Assessment Scale score for observers for the side that received a combination of adhesive strips and buried interrupted subcuticular suturing (12.3 [4.8]) and the side that received sutures only (12.9 [6.3]) did not differ significantly at 3 months (P?=?.32). There was no significant difference in the total patient assessment scale score between the combination closure (14.0 [7.6]) and sutures only (14.7 [7.6]) sides at 3 months (P?=?.39). There was also no significant difference between the 2 closure methods in terms of mean (SD) scar width (both methods: 1.1 [0.8] mm, P?=?.89) at follow-up.Combination closure with adhesive strips and buried interrupted subcuticular suturing was not significantly associated with improved overall scar assessment compared with buried interrupted subcuticular suturing alone when evaluated by blinded observers or the patients themselves. Our results do not support the use of adhesive strips as a means to improve cosmetic outcomes or reduce scar width.clinicaltrials.gov Identifier: NCT01979497.

SUBMITTER: Custis T

PROVIDER: S-EPMC4982140 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material. METHODS/DESIGN:A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. The primary outcome measure will be a composite all-cause wound complication outcome measure composed of: infection, wound drainage, wound necrosis, blistering, dehiscence, suture abscess and material sensitivity reaction. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's?t-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle). A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery. DISCUSSION:Wound closure material is an afterthought for many orthopaedic surgeons. The combined results of several comparative trials suggests that the choice of wound closure materials may have an impact on the rate of surgical site infections. However, the strength of the evidence is poor given the heterogeneity of the methods employed in previous studies. The following study protocol aims to guide surgeons in their choice of wound closure material by determining if there is a difference in complication rates in sutured and stapled wounds. TRIAL REGISTRATION:This trial was registered at ClinicalTrials.gov under the identifier NCT01146236 (registered June 14, 2010).

Project description:BackgroundWound complications following midline laparotomies are common and the main source of postoperative morbidity including superficial or deep wound infection, skin dehiscence, fascia dehiscence, and incisional hernia. Abdominal closure complications are strongly associated with suture technique and material, in addition to other factors related to the patient and type of surgery performed. The traditional technique is to place the fascia sutures 1 cm apart and at least 1 cm away from the fascia edge. A Swedish study described a new technique of placing the sutures 5 mm apart and 5 mm away from the fascia edge, resulting in lower rates of abdominal wound complications. This study has a number of limitations. There is a need for improved quality evidence to convince the surgical community to change the closure technique of abdominal wounds aiming to reduce morbidity, which is exemplified in incisional hernias and other various postop complications.MethodsThis is a 1:1 randomized, controlled, patient- and assessor-blinded, parallel design, superiority trial, with a primary endpoint of incisional hernia at 1 year. The study will be conducted at AUBMC over a 3-year period. Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique. In order to detect a drop of 12% in the incidence of incisional hernia, with 80% power and an alpha of 0.05, we will need to recruit 114 patients per arm. After adjusting for loss to follow-up, target recruitment is 274 subjects. We will compare both arms for the primary, secondary, and exploratory outcomes, using chi-square or t test as appropriate. Univariate and multivariate logistic regression will be done.DiscussionThis trial will assess postop complications following abdominal midline wound closures via two different suturing techniques. This trial will generate evidence-based conclusions that will allow surgeons to assess the role of a new abdominal closure technique in decreasing short- and long-term postoperative complications, for a commonly performed procedure.Trial registrationClinicalTrials.gov NCT03527433 . Registered on 17 May 2018 before starting participant enrollment.

Project description:BackgroundProlonged wound drainage after TKA is associated with increased risk of infection. To decrease wound drainage, tissue adhesive has been suggested as an adjunct to wound closure after TKA; however, no studies of which we are aware have investigated the effect of tissue adhesive in a modern fast-track TKA setting.Questions/purposesThe purpose of this study was to evaluate the effect of wound closure using a high-viscosity tissue adhesive in simultaneous bilateral TKA with respect to (1) postoperative wound drainage, measured as number of dressing changes in the first 72 hours postoperatively; and (2) wound healing assessed using the ASEPSIS score.MethodsThirty patients undergoing simultaneous bilateral TKA were included in the study. The left knee was randomized to receive either standard three-layer closure with staples or the same closure supplemented with tissue adhesive with the opposite treatment used on the contralateral knee. One patient underwent a constrained TKA and underwent revision 2 days after the index procedure and was therefore excluded leaving 29 patients (58 knees) for analysis. Sixty-two percent (n = 18) were female. Mean age was 64 years (range, 42-78 years). Mean body mass index was 28 kg/m (range, 21-38 kg/m). Postoperative wound drainage was evaluated as drainage resulting in a dressing change. The wound dressing was changed if it was soaked to the borders of the absorbable dressing at any point. The nurses changing the dressing were blinded to treatment allocation up to the first dressing change. The number of dressing changes during the first 72 hours postoperatively was recorded. The secondary study endpoint was the ASEPSIS score, which is a clinical score assessing wound healing. ASEPSIS score, measured by a nurse not involved in the treatment, was compared between the groups at 3 weeks followup.ResultsKnees with tissue adhesive underwent fewer dressing changes (median, 0; interquartile range [IQR], 0-1) compared with the contralateral knee (IQR, 1-2; difference of medians, one dressing change; p = 0.001). A total of 59% of knees in the intervention group did not undergo any dressing changes before discharge, whereas 24% of knees in the control group did not undergo any dressing changes before discharge (p = 0.02). The knees in the intervention group and the control group did not differ with respect to ASEPSIS score at 3 weeks.ConclusionsTissue adhesive as an adjunct to standard wound closure after primary TKA reduced the number of dressing changes after surgery, but did not change the appearance or healing of the wound at 3 weeks based on the ASEPSIS scores. Whether the small differences observed here in terms of the number of dressing changes performed will justify the additional costs associated with using this product or whether there are other differences associated with the use of tissue adhesive that may prove important such as patient preferences or longer term differences in wound healing or infection should be studied in the future.Level of evidenceLevel I, therapeutic study.

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Effect of Adhesive Strips and Dermal Sutures vs Dermal Sutures Only on Wound Closure: A Randomized Clinical Trial.

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