TY - JOUR
T1 - Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI-2 Trial)
T2 - study protocol for a randomised controlled pilot trial
AU - Chetter, Ian
AU - Arundel, Catherine Ellen
AU - Fairhurst, Caroline Marie
AU - Rodgers, Sara Anita
AU - Saramago Goncalves, Pedro Rafael
AU - Torgerson, David John
AU - Dixon, Stephen
AU - Henderson, Eileen
AU - Oswald, Angela
AU - Dumville, Jo
AU - Stubbs, Nikki
AU - Buckley, Hannah
AU - Clarke, Emma
AU - Cullum, Nicky
AU - Lamb, Karen
AU - McGinnis, Elizabeth
AU - Soares, Marta O
N1 - © 2021, The Author(s).
PY - 2016/11/8
Y1 - 2016/11/8
N2 - Background: Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips. However, some wounds may break open or be left to heal from the bottom up (i.e. healing by secondary intention). Surgical Wounds Healing by Secondary Intention (SWHSI) are often more complex to manage, and require additional treatments during the course of healing. There is significant uncertainty regarding the best treatment for these complex wounds, with limited robust evidence regarding the clinical and cost-effectiveness of different dressings and treatments; one such treatment is Negative Pressure Wound Therapy (NPWT) which is frequently used in the management of SWHSI. Previous randomised controlled trials (RCTs) of NPWT have failed to recruit to time and target, thus we aimed to conduct a pilot RCT to assess the feasibility of conducting a future, full-scale RCT. Methods: This pilot RCT will test the methods and feasibility of recruiting, randomising, and retaining participants into a larger trial of NPWT verses usual care for patients with SWHSI. Participants will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 3 months. Discussion: This study will provide a full assessment of methods for, and feasibility of, recruiting, randomising, and retaining patients with SWHSI in a trial of NPWT versus usual care. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. Trial registration: Clinical Trial Registry: ISRCTN12761776, registered on 10 December 2015 - retrospective registration.
AB - Background: Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips. However, some wounds may break open or be left to heal from the bottom up (i.e. healing by secondary intention). Surgical Wounds Healing by Secondary Intention (SWHSI) are often more complex to manage, and require additional treatments during the course of healing. There is significant uncertainty regarding the best treatment for these complex wounds, with limited robust evidence regarding the clinical and cost-effectiveness of different dressings and treatments; one such treatment is Negative Pressure Wound Therapy (NPWT) which is frequently used in the management of SWHSI. Previous randomised controlled trials (RCTs) of NPWT have failed to recruit to time and target, thus we aimed to conduct a pilot RCT to assess the feasibility of conducting a future, full-scale RCT. Methods: This pilot RCT will test the methods and feasibility of recruiting, randomising, and retaining participants into a larger trial of NPWT verses usual care for patients with SWHSI. Participants will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 3 months. Discussion: This study will provide a full assessment of methods for, and feasibility of, recruiting, randomising, and retaining patients with SWHSI in a trial of NPWT versus usual care. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. Trial registration: Clinical Trial Registry: ISRCTN12761776, registered on 10 December 2015 - retrospective registration.
KW - Healing
KW - Negative pressure wound therapy
KW - Randomised controlled trial
KW - Secondary intention
KW - Surgical wounds
UR - http://www.scopus.com/inward/record.url?scp=84994475230&partnerID=8YFLogxK
U2 - 10.1186/s13063-016-1661-1
DO - 10.1186/s13063-016-1661-1
M3 - Article
C2 - 27821142
SN - 1745-6215
VL - 17
SP - 1
EP - 7
JO - Trials
JF - Trials
IS - 1
M1 - 535
ER -