Dataset Information

Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial.

ABSTRACT: One of the major risk variables for surgical site infection is wound management. Understanding infection risk factors for breast operations is essential in order to develop infection-prevention strategies and improve surgical outcomes. The aim of this trial is to assess the influence of dressing wear time on surgical site infection rates and skin colonization. Patients' perception at self-assessment will also be analyzed.This is a two-arm randomized controlled trial. Two hundred breast cancer patients undergoing immediate or delayed breast reconstruction will be prospectively enrolled. Patients will be randomly allocated to group I (dressing removed on postoperative day one) or group II (dressing removed on postoperative day six). Surgical site infections will be defined by standard criteria from the Centers for Disease Control and Prevention (CDC). Skin colonization will be assessed by culture of samples collected at predefined time points. Patients will score dressing wear time with regard to safety, comfort and convenience.The evidence to support dressing standards for breast surgery wounds is empiric and scarce. CDC recommends protecting, with a sterile dressing for 24 to 48 hours postoperatively, a primarily closed incision, but there is no recommendation to cover this kind of incision beyond 48 hours, or on the appropriate time to shower or bathe with an uncovered incision. The results of the ongoing trial may support standard recommendations regarding dressing wear time after breast reconstruction.ClinicalTrials.gov identifier: http://NCT01148823.

SUBMITTER: Veiga DF

PROVIDER: S-EPMC3604956 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial.

Veiga Daniela Francescato DF Veiga-Filho Joel J Damasceno Carlos Américo Veiga CA Sales Edilaine Maria Leci EM Morais Thiago Bezerra TB Almeida Wânia Eliza WE Novo Neil Ferreira NF Ferreira Lydia Masako LM

Trials 20130222

<h4>Background</h4>One of the major risk variables for surgical site infection is wound management. Understanding infection risk factors for breast operations is essential in order to develop infection-prevention strategies and improve surgical outcomes. The aim of this trial is to assess the influence of dressing wear time on surgical site infection rates and skin colonization. Patients' perception at self-assessment will also be analyzed.<h4>Methods/design</h4>This is a two-arm randomized cont ...[more]

PMID: 23432779

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Project description:Breast reconstruction using the free muscle-sparing transversus abdominus myocutaneous or deep inferior epigastric perforator flaps are common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdominal donor site remains a major source of postoperative pain. Conventional postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side effects such as sedation, headache, nausea, vomiting, breathing difficulties and bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane peripheral nerve block.This study is a double-blind, placebo-controlled, randomized controlled trial designed to rigorously test the effectiveness of a transversus abdominis plane catheter delivering intermittent local anesthetic in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. The primary objective of this study is compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups including the patient-controlled anesthesia amounts and oral narcotic doses converted to intravenous morphine equivalent units. The secondary outcome measures include the following parameters: total in-hospital cumulative opioid consumption; daily patient-reported pain scores; total in-hospital cumulative anti-nausea consumption; nausea and sedation scores; and Quality of Recovery score; time to first bowel movement, ambulation, and duration of hospital stay.Autologous breast reconstruction using abdominal tissue is rapidly becoming the reconstructive option of choice for postmastectomy patients across North America. A substantial component of the pain experienced by patients after this abdominally based procedure is derived from the abdominal wall incision. By potentially decreasing the need for systemic opioids and their associated side effects, this transversus abdominis plane block study will utilize the most scientifically rigorous double-blind, placebo-controlled, randomized controlled trial methodology to potentially improve both clinical care and health outcomes in breast cancer surgery patients.Clinicaltrials.gov NCT01398982.

Project description:The two-stage tissue expander/implant (TE/I) reconstruction is currently the gold standard method of implant-based immediate breast reconstruction in North America. Recently, however, there have been numerous case series describing the use of one-stage direct to implant reconstruction with the aid of acellular dermal matrix (ADM). In order to rigorously investigate the novel application of ADM in one-stage implant reconstruction, we are currently conducting a multicentre randomized controlled trial (RCT) designed to evaluate the impact on patient satisfaction and quality of life (QOL) compared to the two-stage TE/I technique.The MCCAT study is a multicenter Canadian ADM trial designed as a two-arm parallel superiority trial that will compare ADM-facilitated one-stage implant reconstruction compared to two-stage TE/I reconstruction following skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) at 2 weeks, 6 months, and 12 months. The source population will be members of the mastectomy cohort with stage T0 to TII disease, proficient in English, over the age of 18 years, and planning to undergo SSM or NSM with immediate implant breast reconstruction. Stratified randomization will maintain a balanced distribution of important prognostic factors (study site and unilateral versus bilateral procedures). The primary outcome is patient satisfaction and QOL as measured by the validated and procedure-specific BREAST-Q. Secondary outcomes include short- and long-term complications, long-term aesthetic outcomes using five standardized photographs graded by three independent blinded observers, and a cost effectiveness analysis.There is tremendous interest in using ADM in implant breast reconstruction, particularly in the setting of one-stage direct to implant reconstruction where it was previously not possible without the intermediary use of a temporary tissue expander (TE). This unique advantage has led many patients and surgeons alike to believe that one-stage ADM-assisted implant reconstruction should be the procedure of choice and should be offered to patients as the first-line treatment. We argue that it is crucial that this technique be scientifically evaluated in terms of patient selection, surgical technique, complications, aesthetic outcomes, cost-effectiveness, and most importantly patient-reported outcomes before it is promoted as the new gold standard in implant-based breast reconstruction.ClinicalTrials.gov: NCT00956384.

Project description:BackgroundThe Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.Methods/designThis is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.SettingThe University Health Network, a tertiary care cancer center in Toronto, Canada.ParticipantsAdult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.InterventionWe designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient.ControlUsual care includes access to an informational booklet, website, and patient volunteer if desired.OutcomesExpected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial.DiscussionOur pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013.Trial registrationNCT01857882.

Project description:BACKGROUND:Most breast cancer patients undergoing mastectomy are candidates for breast reconstruction. Deciding about breast reconstruction is complex and the preference-sensitive nature of this decision requires an approach of shared decision making between patient and doctor. Women considering breast reconstruction have expressed a need for decision support. We developed an online patient decision aid (pDA) to support decision making in women considering immediate breast reconstruction. The primary aim of this study is to assess the impact of the pDA in reducing decisional conflict, and more generally, on the decision-making process and the decision quality. Additionally, we will investigate the pDA's impact on health outcomes, explore predictors, and assess its cost-effectiveness. METHODS:A multicenter, two-armed randomized controlled trial (1:1) will be conducted. Women with breast cancer or ductal carcinoma in situ who will undergo a mastectomy and are eligible for immediate breast reconstruction will be invited to participate. The intervention group will receive access to the online pDA, whereas the control group will receive a widely available free information leaflet on breast reconstruction. Participants will complete online questionnaires at: baseline (T0), 1 week after consultation with a plastic surgeon (T1), and 3 (T2) and 12 months (T3) after surgery. The primary outcome is decisional conflict. Secondary outcomes include other measures reflecting the decision-making process and decision quality (e.g., decision regret), patient-reported health outcomes (e.g., satisfaction with the breasts) and costs. DISCUSSION:This study will provide evidence about the impact of an online pDA for women who will undergo mastectomy and are deciding about breast reconstruction. It will contribute to the knowledge on how to optimally support women in making this difficult decision. TRIAL REGISTRATION:This study is retrospectively registered at ClinicalTrials.gov ( NCT03791138 ).

Dataset Information

Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial.

Publications

Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial.

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