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Table 2 Intraoperative, early and late postoperative surgical outcomes, and complication data collection

From: The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction

Intraoperative

Common intraoperative outcomes

Admission status (admitted/not admitted)

Need for completion axillary lymph node dissection (yes/no)

Mastectomy flap deemed to have significant ischemia (yes/no)

Significant mastectomy flap thickness asymmetry between two sides (yes/no)

Mastectomy weight (right breast (g)/left breast (g))

Mastectomy flap thickness (significant dermal exposure/patches of dermis exposed/thin flap without dermis exposed/normal)

Skin incision (horizontal ellipse/vertical ellipse/oblique ellipse/nipple-sparing with inframammary fold incision/nipple-sparing with lateral extension)

Sentinel lymph node biopsy (yes/no, left- and right-side)

Number of drains

Tension with skin closure (present/absent)

First stage of the two-stage

Direct to implant with ADM

TE style

Excess skin excision precluding one-stage implant reconstruction (yes/no)

Initial fill volume (cc)

Size of ADM (cm2)

Implant style

Implant volume (g)

Implant surface and shape (round/anatomic or textured/smooth)

If TE inserted in the place of an implant: reason (implants too large/too small/flap necrosis suspected)

Second stage surgery (exchange to implant)

 

Total TE fill volume (cc)

 

Capsulectomy (total/subtotal/none)

 

Capsulotomy (yes/no)

 

Capsulorrhapy sutures (yes/no)

 

Implant size and style

 

Implant surface and shape (round/anatomic or textured/smooth)

 

Within first 2 months of surgery

Common outcomes

Signs of seroma (yes/no, if yes, amount of fluid drained (cc))

Mastectomy flap viability (100%, 95 to 100%, 80 to 95%, 60 to 80%, <60%)

Need for debridement of necrosis (yes/no, if yes, debrided (cm2))

Signs of infection (yes/no, if yes, name and dosage of antibiotics prescribed)

Signs of incisional dehiscence (yes/no)

Other complications/additional comments

Number of days until drains removed

Two-stage

One-stage with ADM

Need for deflation of TE (yes/no)

Signs of implant malposition (yes/no)

Signs of TE malposition (yes/no)

Signs of implant exposure (yes/no)

Signs of TE exposure (yes/no)

Signs of ADM exposure (yes/no)

Expansion each visit (cc)

 

Long-term complications common to both procedures

Signs of implant malposition (yes/no)

Signs of implant exposure (yes/no)

Signs of implant rippling (yes/no, if yes, superior/medial)

Symmetry (overall) (poor/fair/good/outstanding/excellent)

Symmetry of inframammary fold (poor/fair/good/outstanding/excellent)

Hypertrophic or keloid scar present (yes/no, assessed for each breast)

Aesthetics (poor/fair/good/outstanding/excellent, assessed for each breast)

Capsular contracture (none/II barely visible, palpable/III visible, palpable/IV severe, painful, assessed for each breast)

  1. ADM, acellular dermal matrix; TE, tissue expander.