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Dialkylcarbamoyl chloride-coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study).

ABSTRACT: BACKGROUND:Disease of the pilonidal sinus is a common condition that affects mainly young adults. Options for management include excision of the sinus tracts, leaving the wound open to heal by secondary intention. The aim of this study was to compare wound healing with dialkylcarbamoyl chloride (DACC)-coated dressings versus alginate dressings. METHODS:This multicentre trial randomized consecutive patients undergoing surgery for pilonidal disease to postoperative wound care with either DACC-coated or alginate dressings. The primary outcome was the proportion of wounds healed after 75?days. Secondary outcomes were the local status of wounds during the healing process, the quality assessment of the dressings by the patient, and the time needed to return to usual activities. RESULTS:A total of 246 patients were included: 120 in the DACC-coated group and 126 in the alginate group. In per-protocol analysis, there were significantly more patients with completely healed wounds after 75?days in the DACC group than in the alginate group: 78 of 103 (75·7 per cent) versus 58 of 97 (60 per cent) respectively (odds ratio 2·55, 95 per cent c.i. 1·12 to 5·92; P = 0·023). During follow-up, wounds with alginate dressings had more fibrin than those with DACC-coated dressings, but the difference was not significant (P = 0·079). There was no difference between the two arms in patients' assessment of the dressings. CONCLUSION:The number of wounds completely healed at 75?days was significantly higher for DACC-coated compared with alginate dressings. However, the preplanned, clinically significant improvement in healing of 20 per cent was not reached. Registration number: NCT02011802 ( https://clinicaltrials.gov/).

SUBMITTER: Romain B

PROVIDER: S-EPMC7093794 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Dialkylcarbamoyl chloride-coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study).

Romain B B Mielcarek M M Delhorme J B JB Meyer N N Brigand C C Rohr S S

BJS open 20200204 2

<h4>Background</h4>Disease of the pilonidal sinus is a common condition that affects mainly young adults. Options for management include excision of the sinus tracts, leaving the wound open to heal by secondary intention. The aim of this study was to compare wound healing with dialkylcarbamoyl chloride (DACC)-coated dressings versus alginate dressings.<h4>Methods</h4>This multicentre trial randomized consecutive patients undergoing surgery for pilonidal disease to postoperative wound care with e ...[more]

PMID: 32020765

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Project description:AimsThe primary objective of this study was to compare the postoperative infection rate between negative pressure wound therapy (NPWT) and conventional dressings for closed incisions following soft-tissue sarcoma (STS) surgery. Secondary objectives were to compare rates of adverse wound events and functional scores.MethodsIn this prospective, single-centre, randomized controlled trial (RCT), patients were randomized to either NPWT or conventional sterile occlusive dressings. A total of 17 patients, with a mean age of 54 years (21 to 81), were successfully recruited and none were lost to follow-up. Wound reviews were undertaken to identify any surgical site infection (SSI) or adverse wound events within 30 days. The Toronto Extremity Salvage Score (TESS) and Musculoskeletal Tumor Society (MSTS) score were recorded as patient-reported outcome measures (PROMs).ResultsThere were two out of seven patients in the control group (28.6%), and two out of ten patients in the intervention group (20%) who were diagnosed with a SSI (p > 0.999), while one additional adverse wound event was identified in the control group (p = 0.593). No significant differences in PROMs were identified between the groups at either 30 days (TESS, p = 0.987; MSTS, p = 0.951) or six-month (TESS, p = 0.400) follow-up. However, neoadjuvant radiotherapy was significantly associated with a SSI within 30 days of surgery, across all patients (p = 0.029). The mean preoperative modified Glasgow Prognostic Score (mGPS) was also significantly higher among patients who developed a postoperative adverse wound event (p = 0.028), including a SSI (p = 0.008), across both groups.ConclusionThis is the first RCT comparing NPWT with conventional dressings following musculoskeletal tumour surgery. Postoperative wound complications are common in this group of patients and we observed an overall SSI rate of 23.5%. We propose proceeding to a multicentre trial, which will help more clearly define the role of closed incision NPWT in STS surgery. Cite this article: Bone Jt Open 2021;2(12):1049-1056.

Project description:Background: The advent of pediatric endoscopic pilonidal sinus treatment (PEPSiT) has dramatically changed the surgical management of pilonidal sinus disease (PSD) in children and adolescents. This study aimed to report the outcome of our new structurated protocol, including PEPSiT, laser epilation, and oxygen-enriched oil-based gel dressing, for treatment of PSD in pediatric patients and describe tips and tricks of the technique. Methods: We retrospectively reviewed the data of 127 pediatric patients, who underwent PEPSiT for PSD in our institutions over a 36-month period. All patients received laser epilation (LE) before and after surgery. Post-operative dressing was performed using silver sulfadiazine spray and in the last 18 months oxygen-enriched oil-based gel. We divided the patients in two groups according to the protocol adopted: G1 (laser + oxygen-enriched oil-based gel dressing) included 72 patients and G2 (laser + silver sulfadiazine spray dressing) included 55 patients. The two groups were compared regarding success rate, recurrence, wound infection rate, wound healing time, post-operative outcome, time to full daily activities and patient satisfaction. Results: No difference emerged between the two groups regarding the average operative time, the average post-operative pain score, the average analgesic requirement, the average hospitalization and the average time to full daily activities (p = 0.33). No intra- or post-operative complications including wound infection occurred in both groups. The patients required an average number of 7 LE sessions (range 4-10) to achieve complete hair removal. The overall success rate was significantly higher in G1 (n = 71, 98.6%) compared with G2 (n = 50, 90.9%) [p = 0.001]. The recurrence rate was also significantly lower in G1 (n = 1, 1.4%) compared with G2 (n = 5, 9%) [p = 0.001]. Furthermore, G1 reported a faster wound healing (average 21 days) compared with G2 (average 29 days) [p = 0.001] and a higher patient satisfaction score (average 4.9) compared with G2 (average 4.2) [p = 0.001]. Conclusions: Based upon our experience, PEPSiT may be considered the standard of care for surgical treatment of PSD in children and adolescents. Our new structurated protocol consisting of pre-operative LE, PEPSiT, and post-operative wound management with oxygen-enriched oil-based gel dressing and LE, allowed to achieve an excellent outcome, with a success rate > 98%.

Project description:ObjectiveTo determine the relative effects of open healing compared with primary closure for pilonidal sinus and optimal closure method (midline v off-midline).DesignSystematic review and meta-analyses of randomised controlled trials.Data sourcesCochrane register of controlled trials, Cochrane Wounds Group specialised trials register, Medline (1950-2007), Embase, and CINAHL bibliographic databases, without language restrictions.Data extractionPrimary outcomes were time (days) to healing, surgical site infection, and recurrence rate. Secondary outcomes were time to return to work, other complications and morbidity, cost, length of hospital stay, and wound healing rate.Study selectionRandomised controlled trials evaluating surgical treatment of pilonidal sinus in patients aged 14 years or more. Data were extracted independently by two reviewers and assessed for quality. Meta-analyses used fixed and random effects models, dichotomous data were reported as relative risks or Peto odds ratios and continuous data are given as mean differences; all with 95% confidence intervals.Results18 trials (n=1573) were included. 12 trials compared open healing with primary closure. Time to healing was quicker after primary closure although data were unsuitable for aggregation. Rates of surgical site infection did not differ; recurrence was less likely to occur after open healing (relative risk 0.42, 0.26 to 0.66). 14 patients would require their wound to heal by open healing to prevent one recurrence. Six trials compared surgical closure methods (midline v off-midline). Wounds took longer to heal after midline closure than after off-midline closure (mean difference 5.4 days, 95% confidence interval 2.3 to 8.5), rate of infection was higher (relative risk 4.70, 95% confidence interval 1.93 to 11.45), and risk of recurrence higher (Peto odds ratio 4.95, 95% confidence interval 2.18 to 11.24). Nine patients would need to be treated by an off-midline procedure to prevent one surgical site infection and 11 would need to be treated to prevent one recurrence.ConclusionsWounds heal more quickly after primary closure than after open healing but at the expense of increased risk of recurrence. Benefits were clearly shown with off-midline closure compared with midline closure. Off-midline closure should become standard management for pilonidal sinus when closure is the desired surgical option.

Dataset Information

Dialkylcarbamoyl chloride-coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study).

Publications

Dialkylcarbamoyl chloride-coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study).

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