Skip to main content
. 2022 Apr 26;2022(4):CD009261. doi: 10.1002/14651858.CD009261.pub7

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
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.
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
Outcomes
  • The number of wound‐healing complications within 21 days

  • Aesthetic appearance and quality of scarring (additional measurements at 42, 90, 180, and 365 days)


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.
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.