Study: NCT03838575

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 2% alcoholic chlorhexidine skin prep (SKIN PREP)
Description: This intervention describes the preparation of the intact skin incision site immediately prior to incision, using chlorhexidine gluconate (CHG) in an alcohol-based solution, providing durable sterilisation of the surgical field. Pre-prepared applicators will be available for use in this trial (ChloraPrep™ sticks, 2% CHG with 70% isopropyl alcohol, BD Infection Prevention).

Intervention type: DRUG
Group type: OTHER
Intervention: 2% alcoholic chlorhexidine skin prep (SKIN PREP)
Description: This intervention describes the preparation of the intact skin incision site immediately prior to incision, using chlorhexidine gluconate (CHG) in an alcohol-based solution, providing durable sterilisation of the surgical field. Pre-prepared applicators will be available for use in this trial (ChloraPrep™ sticks, 2% CHG with 70% isopropyl alcohol, BD Infection Prevention).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 2% alcoholic chlorhexidine skin prep (SKIN PREP)
Description: This intervention describes the preparation of the intact skin incision site immediately prior to incision, using chlorhexidine gluconate (CHG) in an alcohol-based solution, providing durable sterilisation of the surgical field. Pre-prepared applicators will be available for use in this trial (ChloraPrep™ sticks, 2% CHG with 70% isopropyl alcohol, BD Infection Prevention).

Intervention type: DRUG
Group type: OTHER
Intervention: 2% alcoholic chlorhexidine skin prep (SKIN PREP)
Description: This intervention describes the preparation of the intact skin incision site immediately prior to incision, using chlorhexidine gluconate (CHG) in an alcohol-based solution, providing durable sterilisation of the surgical field. Pre-prepared applicators will be available for use in this trial (ChloraPrep™ sticks, 2% CHG with 70% isopropyl alcohol, BD Infection Prevention).

Intervention type: DEVICE
Group type: OTHER
Intervention: Iodophor Antimicrobial Incise Drapes (DRAPE)
Description: Please note: In January 2022, following the first interim analysis, arms including intervention 2 - Iodophor-impregnated incise drape (arms C, E, G and H) were closed to recruitment.~This intervention describes the application of a single Iodophor Antimicrobial Incise Drape to be applied topically onto the prepared and draped surgical field by sterile, gloved members of the surgical team before the surgical incision is performed. Only after the skin preparation solution has dried completely can the incise drape be applied.

Intervention type: DEVICE
Group type: OTHER
Intervention: Iodophor Antimicrobial Incise Drapes (DRAPE)
Description: Please note: In January 2022, following the first interim analysis, arms including intervention 2 - Iodophor-impregnated incise drape (arms C, E, G and H) were closed to recruitment.~This intervention describes the application of a single Iodophor Antimicrobial Incise Drape to be applied topically onto the prepared and draped surgical field by sterile, gloved members of the surgical team before the surgical incision is performed. Only after the skin preparation solution has dried completely can the incise drape be applied.

Intervention type: DEVICE
Group type: OTHER
Intervention: Iodophor Antimicrobial Incise Drapes (DRAPE)
Description: Please note: In January 2022, following the first interim analysis, arms including intervention 2 - Iodophor-impregnated incise drape (arms C, E, G and H) were closed to recruitment.~This intervention describes the application of a single Iodophor Antimicrobial Incise Drape to be applied topically onto the prepared and draped surgical field by sterile, gloved members of the surgical team before the surgical incision is performed. Only after the skin preparation solution has dried completely can the incise drape be applied.

Intervention type: DEVICE
Group type: OTHER
Intervention: Iodophor Antimicrobial Incise Drapes (DRAPE)
Description: Please note: In January 2022, following the first interim analysis, arms including intervention 2 - Iodophor-impregnated incise drape (arms C, E, G and H) were closed to recruitment.~This intervention describes the application of a single Iodophor Antimicrobial Incise Drape to be applied topically onto the prepared and draped surgical field by sterile, gloved members of the surgical team before the surgical incision is performed. Only after the skin preparation solution has dried completely can the incise drape be applied.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Gentamicin-impregnated implants/ sponges (SPONGE)
Description: This intervention describes the implantation of Gentamicin-impregnated collagen implants at the time of fascial closure. Each sponge (10 by 10 cm) contains 280mg of collagen and 130mg of gentamicin. The sponges gradually degrade and the gentamicin solution permeates into surrounding tissues to create a high local antimicrobial concentration within the surgical wound.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Gentamicin-impregnated implants/ sponges (SPONGE)
Description: This intervention describes the implantation of Gentamicin-impregnated collagen implants at the time of fascial closure. Each sponge (10 by 10 cm) contains 280mg of collagen and 130mg of gentamicin. The sponges gradually degrade and the gentamicin solution permeates into surrounding tissues to create a high local antimicrobial concentration within the surgical wound.

Intervention type: DEVICE
Group type: OTHER
Intervention: Gentamicin-impregnated implants/ sponges (SPONGE)
Description: This intervention describes the implantation of Gentamicin-impregnated collagen implants at the time of fascial closure. Each sponge (10 by 10 cm) contains 280mg of collagen and 130mg of gentamicin. The sponges gradually degrade and the gentamicin solution permeates into surrounding tissues to create a high local antimicrobial concentration within the surgical wound.

Intervention type: DEVICE
Group type: OTHER
Intervention: Gentamicin-impregnated implants/ sponges (SPONGE)
Description: This intervention describes the implantation of Gentamicin-impregnated collagen implants at the time of fascial closure. Each sponge (10 by 10 cm) contains 280mg of collagen and 130mg of gentamicin. The sponges gradually degrade and the gentamicin solution permeates into surrounding tissues to create a high local antimicrobial concentration within the surgical wound.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: NONE (Control)
Description: Any skin preparation of the surgeon's choice may be used in the control arm apart from 2.0% Alcoholic Chlorhexidine Skin Prep.~No drapes or sponges of any kind may be used.