Tanaydin 2018.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Study grouping: parallel Ethics and informed consent: ethics approved and consent obtained Sample size calculation: no Follow‐up period: 365 days postsurgery ITT analysis: wounds (breasts), not people were assessed Funding: funded by Smith & Nephew Ltd, who provided the PICO dressings and the Cutometer and financed a research assistant for carrying out the assessments and measurements |
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Participants |
Location: the Netherlands Intervention group: n = 32,control group: n = 32 (participants served as their own control) Mean age (range): 40.9 (18 to 61) Inclusion criteria: patients > 18 years of age who underwent bilateral superomedial pedicle Wise‐pattern breast reduction mammoplasty and had postsurgical incisions of similar length on each breast. Exclusion criteria: pregnancy or lactation, using steroids, or other immune modulators known to affect wound healing; history of radiation of the breast; tattoos in the area of the incision; skin conditions such as cutis laxa that would result in poor healing or widen scars, history of radiation of the breast, patients with a known significant history of hypertrophic scarring or keloids, and postsurgical incisions still actively bleeding, exposure of blood vessels, organs, bone, or tendon at the base of the reference wound; and incisions > 12 inches (30 cm) maximum linear dimension. |
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Interventions |
Aim/s: to evaluate the effectiveness of postsurgery incision treatment comparing a portable disposable NPWT system with standard care using fixation strips. Group 1 (NPWT) intervention: a single‐use NPWT system without an exudate canister Group 2 (control) intervention: fixation strips (Steri‐Strip; 3M, St Paul, Minnesota, USA) Study date/s: 1 June 2012 to 9 April 2014 |
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Outcomes |
Validity of measure/s: wound‐healing complications were defined as delayed healing (surgical incision not 100% closed at day 7 postsurgery), or occurrence of dehiscence or infection within 21 days postsurgery. Time points: all included participants (N = 32) had follow‐up visits and assessments at screening (pre‐surgery), day 0 (baseline, postsurgery), day 7, 21, 42, 90, 180, and 365 postsurgery. |
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Notes | The breasts were randomised and served as own control. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was used for allocation of NPWT and fixation strip to the right or left breast incision site per patient, using sealed envelopes. Treatment site information was accessed digitally (www.sealedenvelope.com) upon the start of the treatment postsurgically." Comment: appeared to be a computerised method of sequence generation. |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was used for allocation of NPWT and fixation strip to the right or left breast incision site per patient, using sealed envelopes. Treatment site information was accessed digitally (www.sealedenvelope.com) upon the start of the treatment postsurgically." Comment: appeared to be a web‐based allocation centre. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "As NPWT and fixation strips are optically different, blinding of the physician and patients was not feasible". Comment: participants and personnel were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "as NPWT and fixation strips are optically different, blinding of the physician and patients was not feasible; however, data analysis was performed blinded". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 32 enrolled participants were accounted for in the analyses. |
Selective reporting (reporting bias) | Low risk | Expected outcomes reported. Protocol retrospectively registered as NL40698.068.12/METC12‐3‐026. |
Other bias | Unclear risk | This was a 'split‐body' or 'intra‐individual' design where a person with 2 wounds had 1 wound randomised to each treatment. It was not clear whether the analysis took this into account. |